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	<title>Thought Leadership</title>
	<link>https://www.prometrika.com/thought-leadership/thought-leadership/</link>
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	<description>As a leading clinical research organization (CRO), we are continuously innovating, thinking, problem solving and sharing our knowledge and insights. Our Thought Leadership section of our website supports these efforts while providing valuable articles we thinking you&#x00027;ll enjoy reading.</description>
	<pubDate>Mon, 16 Mar 2026 16:32:04 -0400</pubDate>
	<ttl>60</ttl>
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		<title>Global Trial Challenge:  The Logistics of International Trials</title>
		<description><![CDATA[Today, international trials make up the majority (~65% on clinicaltrials.gov) of ongoing clinical trials. For sponsors and patients, the globalization of drug development has shortened the time to commercialization in key markets and expanded the availability of important new treatments. But globalization comes with a number of challenges, not the least of which is mastering logistics across countries, regions, and time zones. PROMETRIKA has formed strategic partnerships with like-minded and similarly sized local CROs in over 80 countries on 5 continents. These relationships optimize the management of key logistic concerns such as time zone differences, supply chain consistency, language barriers, and ethical and cultural considerations.]]></description>
		<pubDate>Tue, 10 Mar 2026 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-the-logistics-of-international-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-the-logistics-of-international-trials/</guid>
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		<title>Reflections from SCOPE 2026: Balancing Patient Centricity with High-Tech Innovation</title>
		<description><![CDATA[SCOPE 2026 in Orlando this year felt like a pivotal moment for our industry. It wasn’t just about the latest technical innovations, it was about how we ground these innovations in the human experience.

My conference experience began at dawn with Sunrise Yoga: In Gratitude for Clinical Research Participants, organized by CISCRP. PROMETRIKA, was proud to sponsor an event that centers on the very people who make our work possible. Practicing yoga as the sun rose over Orlando was a “grounded” way to start the week– it reminded me that behind every data point is a human life. The calm did not last long, though, as the conference was packed, the exhibit hall vendors were hungry, and the energy was high.]]></description>
		<pubDate>Fri, 13 Feb 2026 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/reflections-from-scope-2026-balancing-patient-centricity-with-high-tech-innovation/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/reflections-from-scope-2026-balancing-patient-centricity-with-high-tech-innovation/</guid>
	</item>
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		<title>Why Beacon Academy Matters to Me &#x00026; PROMETRIKA’s Support of My Community Involvement</title>
		<description><![CDATA[When I take a moment to reflect on what led me to be the person I am today, the road to success in all of my accomplishments began at Beacon Academy. I am a member of the founding class of 2006, and the profound impact Beacon Academy has is truly 14 months that last a lifetime.

Beacon Academy is more than just a school. It’s a 10-year program for students from historically under-resourced communities, catalyzed by a transformational “Beacon Year” between 8th and 9th grade. This gap year is designed to prepare highly motivated students to succeed in top-tier high schools, colleges, and ultimately, fulfilling careers. Beyond academics, Beacon supports its students with a variety of resources including financial assistance, college and career guidance, care packages, and a powerful alumni network. Their mission is rooted in advancing educational equity and closing the opportunity gap by making a long-term commitment and investment in its students.]]></description>
		<pubDate>Tue, 03 Feb 2026 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/why-beacon-academy-matters-to-me-prometrikas-support-of-my-community-involvement/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/why-beacon-academy-matters-to-me-prometrikas-support-of-my-community-involvement/</guid>
	</item>
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		<title>Successful Split Release of Clinical Electronic Data Capture Systems (EDC)</title>
		<description><![CDATA[Building a robust and efficient electronic data capture system (EDC) for today’s complex clinical trials is a major undertaking. The elements of the EDC must be carefully planned, the programming must be succinct, and the risks to data integrity must be considered. Clearly, these crucial requirements demand careful thought and can be time-consuming. An option for the timely initiation of a trial may be to split the release (a.k.a., the “go-live”) of EDC elements in a controlled and considered manner. PROMETRIKA’s Data Management team has extensive experience with planning and executing successful split-release EDCs.]]></description>
		<pubDate>Thu, 08 Jan 2026 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/successful-split-release-of-clinical-electronic-data-capture-systems-edc/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/successful-split-release-of-clinical-electronic-data-capture-systems-edc/</guid>
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		<title>Global Trial Challenge: Data Quality and Integrity</title>
		<description><![CDATA[Sponsors of global trials face many challenges. One of the most sensitive concerns is appropriate collection and handling of clinical data. Data managers face variation in data collection methods and clinical trial practices among the countries or regions participating in a global trial. PROMETRIKA’s successful approach to data integrity includes strong global oversight and advanced technology and processes.]]></description>
		<pubDate>Thu, 04 Dec 2025 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-data-quality-and-integrity/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-data-quality-and-integrity/</guid>
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		<title>Highlights from the 8th Annual New England Rare Disease Statistics (NERDS) Workshop 2025: Transforming Rare Disease Drug Development</title>
		<description><![CDATA[The 2025 New England Rare Disease Statistics (NERDS) workshop, held on October 9-10 in Boston, brought together leading biostatisticians, data scientists, clinical researchers, and regulatory professionals from academia and industry. This workshop served as an important forum for exchanging innovative ideas aimed at addressing the unique statistical and regulatory challenges inherent to rare disease drug research and development. At PROMETRIKA, we continue to advance collective expertise and strengthen our contributions to successful clinical development.]]></description>
		<pubDate>Fri, 28 Nov 2025 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-the-8th-annual-new-england-rare-disease-statistics-nerds-workshop-2025-transforming-rare-disease-drug/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-the-8th-annual-new-england-rare-disease-statistics-nerds-workshop-2025-transforming-rare-disease-drug/</guid>
	</item>
	<item>
		<title>PROMETRIKA’s Culture of Risk Management and Inspection Readiness</title>
		<description><![CDATA[The PROMETRIKA team attended the Fierce Biotech Week conference, which offered a front row seat to the evolving landscape of clinical research, where innovation is not just a buzzword but a driving force. The conversations centered around the growing adoption of Risk-Based Quality Management (RBQM) and the ongoing evolution of the Trial Master File (TMF) as a critical tool for inspection readiness. These topics not only dominated sessions and panels, they sparked dynamic roundtable discussions, signaling a shift in how the industry is approaching trial efficiency, compliance and data integrity.]]></description>
		<pubDate>Thu, 20 Nov 2025 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/prometrikas-culture-of-risk-management-and-inspection-readiness/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/prometrikas-culture-of-risk-management-and-inspection-readiness/</guid>
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		<title>Quantitative Decision-making Enhanced by AI Advances</title>
		<description><![CDATA[As the role of statisticians continues to change in a rapidly advancing digital landscape, adaptability and continued learning matter now more than ever. To this end, PROMETRIKA supports its team members in attending conferences where the most current methods and industry guidance are discussed. the annual American Statistical Association (ASA) Biopharmaceutical Section Regulatory-Industry Statistics Workshop in Rockville, MD,features representation from the pharmaceutical industry, academia, and the FDA. The most recent conference focused heavily on the evolving role of statisticians in the artificial intelligence (AI) and machine learning (ML) era. A consensus emerged regarding AI and ML, following innovative perspectives shared by several speakers. While both are viewed as powerful tools with great potential to more efficiently deliver life-saving therapies to patients, caution must be exercised in model implementation.]]></description>
		<pubDate>Fri, 14 Nov 2025 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/quantitative-decision-making-enhanced-by-ai-advances/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/quantitative-decision-making-enhanced-by-ai-advances/</guid>
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	<item>
		<title>From Envelopes to AI: The Evolution and Future of IRT in Clinical Trials</title>
		<description><![CDATA[At PROMETRIKA, we continuously evaluate how emerging technologies can strengthen clinical trial execution, compliance, and data integrity. As trials become more complex and adaptive, systems like Interactive Response Technologies (IRT) - also known as Randomization and Trial Supply Management (RTSM) – need to adapt accordingly to keep up with the increased demands of these trial designs.]]></description>
		<pubDate>Mon, 03 Nov 2025 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/from-envelopes-to-ai-the-evolution-and-future-of-irt-in-clinical-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/from-envelopes-to-ai-the-evolution-and-future-of-irt-in-clinical-trials/</guid>
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	<item>
		<title>The Growing Applications of Artificial Intelligence and Machine Learning in Biostatistics and Data Science</title>
		<description><![CDATA[The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is held annually in Rockville, MD to provide biostatisticians with the opportunity to collaborate and expand the frontiers of statistical knowledge. The 2025 ASA conference centered around the future of statistics in the era of artificial intelligence (AI) and machine learning (ML). Two statisticians attended on behalf of PROMETRIKA to explore current AI/ML research efforts and use cases from statisticians across industry, academia, and regulatory agencies. Across a three-day series of short courses, speaker sessions, panels, roundtables, and poster sessions, a clear message emerged that AI/ML has a strong potential to improve statistical frameworks throughout the drug development life cycle.]]></description>
		<pubDate>Wed, 15 Oct 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-growing-applications-of-artificial-intelligence-and-machine-learning-in-biostatistics-and-data-science/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-growing-applications-of-artificial-intelligence-and-machine-learning-in-biostatistics-and-data-science/</guid>
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		<title>AI-driven Tools Enhance Data Management</title>
		<description><![CDATA[The development of ‘artificial intelligence’(AI)-driven tools for data management has accelerated in the past few years. The promise of these systems is to provide a more intuitive experience for data management and sponsor teams, making it easier to track trends, spot anomalies, and generate near-real time data reports. These features, combined with AI’s ability to learn from data, make these tools a modern essential for improving data quality and accelerating clinical trials.]]></description>
		<pubDate>Wed, 01 Oct 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/ai-driven-tools-enhance-data-management/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/ai-driven-tools-enhance-data-management/</guid>
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		<title>Paper vs. Electronic: Patient Reported Outcomes in Clinical Trials</title>
		<description><![CDATA[Leveraging the advantages of electronically captured patient-reported data in early phase trials

As clinical trial planning begins, PROMETRIKA Clinical Trial Managers (CTMs) and Project Managers (PMs) are often asked by Sponsors to assess the pros and cons of using paper documentation (e.g., diaries) vs. electronic data entry for patient-reported data. Our broad experience with different phases of clinical trials helps us advise Sponsors on this decision.]]></description>
		<pubDate>Thu, 18 Sep 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/paper-vs-electronic-patient-reported-outcomes-in-clinical-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/paper-vs-electronic-patient-reported-outcomes-in-clinical-trials/</guid>
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		<title>eTMF Maintenance: Best Practices for an Inspection-Ready eTMF</title>
		<description><![CDATA[The importance of keeping an inspection-ready electronic trial master file (eTMF) at all times cannot be understated; the TMF tells the story of the clinical trial and should serve as the ultimate source of truth for the study. An inspection-ready TMF is complete without being redundant and efficient while still upholding high standards of quality. This might sound like a lot of work, but don’t let it intimidate you; an inspection-ready TMF can be achieved by following the steps outlined below.]]></description>
		<pubDate>Tue, 05 Aug 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/etmf-maintenance-best-practices-for-an-inspection-ready-etmf/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/etmf-maintenance-best-practices-for-an-inspection-ready-etmf/</guid>
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		<title>Highlights from PharmaSUG 2025: Optimizing SAS Programming Pipelines Using the %Unpack and %SearchReplace Macros for Version Control and Customization</title>
		<description><![CDATA[We had the opportunity to present our paper, “Optimizing SAS Programming Pipelines Using the %Unpack and %SearchReplace Macros for Version Control and Customization”, written by Ning Ning, Statistical Programmer I, and Assir Abushouk, Manager, Statistical Programming, at PharmaSUG 2025 in San Diago. The presentation focused on a practical SAS macro program we developed to address common challenges in clinical programming, particularly around version control, customization, and study startup efficiency in CROs.]]></description>
		<pubDate>Mon, 28 Jul 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-pharmasug-2025-optimizing-sas-programming-pipelines-using-the-unpack-and-searchreplace-macros-for-version/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-pharmasug-2025-optimizing-sas-programming-pipelines-using-the-unpack-and-searchreplace-macros-for-version/</guid>
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		<title>Highlights from PharmaSUG 2025: Automating SAE Reconciliation with SAS e-Poster</title>
		<description><![CDATA[PROMETRIKA’s Biostatics and Statistical Programming teams continually seek new and innovative ways to address the many functions of data analysis in clinical research. Our statistical programmers have had numerous successes in researching and developing new programs and methods that reduce time and steps in analyses.]]></description>
		<pubDate>Mon, 14 Jul 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-pharmasug-2025-automating-sae-reconciliation-with-sas-e-poster/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-pharmasug-2025-automating-sae-reconciliation-with-sas-e-poster/</guid>
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		<title>SDTM with a Twist: Unconventional Data Mapping Presentation at CDISC Interchange Europe</title>
		<description><![CDATA[At the recent CDISC Europe Interchange in Geneva, I had the honor of presenting the details of a project mapping clinical data into CDISC SDTM, with a twist. It was a small healthy volunteer study run at a single clinic where the site investigator built the data capture system in REDCap. ]]></description>
		<pubDate>Thu, 26 Jun 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/sdtm-with-a-twist-unconventional-data-mapping-presentation-at-cdisc-interchange-europe/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/sdtm-with-a-twist-unconventional-data-mapping-presentation-at-cdisc-interchange-europe/</guid>
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		<title>World Orphan Drug Congress 2025</title>
		<description><![CDATA[Team members at PROMETRIKA are encouraged to stay abreast of scientific and regulatory advancements in biopharma by attending industry conferences. Earlier this year, I took this opportunity to attend the World Orphan Drug Congress 2025 in Boston. Some of the brightest minds in biotech, pharma, patient advocacy, and regulatory sciences met to discuss and brainstorm around one of healthcare’s most complex challenges: rare diseases. Urgency and innovation were highlighted through powerful keynote speeches, deeply personal fireside chats, and content rich panels focused on everything from patient identification to artificial intelligence in clinical care. I’d like to share some highlights from my experience and the sessions I joined.]]></description>
		<pubDate>Fri, 30 May 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/world-orphan-drug-congress-2025/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/world-orphan-drug-congress-2025/</guid>
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		<title>A Day in the Life: Database Programmer Edition</title>
		<description><![CDATA[Some folks may think the clinical study Database Programmer is a silent partner; technical by nature and quietly working behind the scenes. Not at PROMETRIKA. At PROMETRIKA, our Database Programmers are fully engaged with the entire study team. Yes, they are technical, and they are much more. Here’s what to expect when working with the Database Programming team at PROMETRIKA.]]></description>
		<pubDate>Thu, 22 May 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-database-programmer-edition/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-database-programmer-edition/</guid>
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		<title>What the 2025 MDA Conference Reminded Me About the Heart of Clinical Research</title>
		<description><![CDATA[Attending the 2025 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference was more than just a professional checkpoint; it was a much-needed reminder of why we do what we do. I am a Sr. Clinical Trial Manager at PROMETRIKA, a full-service CRO based in Cambridge, MA. Every day, I am engaged in the meaningful work of advancing treatments for patients across many therapeutic areas.]]></description>
		<pubDate>Wed, 30 Apr 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/what-the-2025-mda-conference-reminded-me-about-the-heart-of-clinical-research/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/what-the-2025-mda-conference-reminded-me-about-the-heart-of-clinical-research/</guid>
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		<title>Serving the Community Together</title>
		<description><![CDATA[Are you in the Boston area and looking for a community service activity in which to participate with your coworkers? Consider volunteering at Community Servings in Jamaica Plain. This nonprofit organization provides medically-tailored meals to thousands of people in Massachusetts and Rhode Island experiencing a range of critical and chronic illnesses. They rely heavily on volunteers to help prepare and package an impressive 20,000-plus scratch-made meals weekly.  ]]></description>
		<pubDate>Thu, 17 Apr 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/serving-the-community-together/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/serving-the-community-together/</guid>
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		<title>PROMETRIKA Sponsors MassBio Rare Disease Day Forum</title>
		<description><![CDATA[PROMETRIKA was one of the proud sponsors of the MassBio Rare Disease Day Forum in Boston. Several of PROMETRIKA’s team members from Clinical Operations, Biostatistics, and Project Management came away from the event with new insights and increased dedication to contributing in the rare disease space.]]></description>
		<pubDate>Tue, 18 Mar 2025 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/prometrika-sponsors-massbio-rare-disease-day-forum/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/prometrika-sponsors-massbio-rare-disease-day-forum/</guid>
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		<title>Global Trial Challenge:  Diverse Regulatory Requirements</title>
		<description><![CDATA[The globalization of drug development has shortened the time to commercialization in key markets and expanded the availability of important new treatments. Before the ability to efficiently conduct a global clinical trial, separate region-specific trials were required in a number of major markets. Recent advances in technology, and collaborations among regulatory agencies, have shortened the time to gathering the data necessary for multi-region approvals. But globalization comes with a number of challenges that may be daunting for small and emerging biopharma companies. For these sponsors, there are advantages to partnering with a small global CRO. Here, we will look at PROMETRIKA’s solution to meeting the diverse regulatory requirements presented by global trials.]]></description>
		<pubDate>Fri, 28 Feb 2025 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-diverse-regulatory-requirements/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-diverse-regulatory-requirements/</guid>
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		<title>Communication and Collaboration: The Through-Line at the 2024 CDISC US Interchange</title>
		<description><![CDATA[The annual CDISC US Interchange conference is an opportunity for PROMETRIKA’s Statistical Programming team to learn about the newest ideas and trends for data dissemination in the industry. At this year’s gathering, between the keynote speaker’s sentiments, the FDA’s opening thoughts, and the breakout sessions – one idea carried through each talk; how do we increase communication and collaboration across all functions to make everyone’s life easier and reduce the work load placed on all involved – from Sponsors to CROs to the FDA to patients?]]></description>
		<pubDate>Tue, 07 Jan 2025 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/communication-and-collaboration-the-through-line-at-the-2024-cdisc-us-interchange/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/communication-and-collaboration-the-through-line-at-the-2024-cdisc-us-interchange/</guid>
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		<title>Global Trial Challenge:  Effective Management of Global Trials</title>
		<description><![CDATA[More than 64% of the trials posted on clinicaltrials.gov include at least one country outside of North America. For American-based sponsors, expanding trials outside the scope of North American regulators raises concerns around regulatory compliance, logistical methods, and participant wellbeing. Overarching all of these challenges is the question of how well international trials can be managed. PROMETRIKA has developed a management model to ensure informed and efficient communication and activities during global trials.]]></description>
		<pubDate>Tue, 31 Dec 2024 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-effective-management-of-global-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/global-trial-challenge-effective-management-of-global-trials/</guid>
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	<item>
		<title>Time Crunch – Making the Most of What Time We Have (and Why the Human is Still the Most Important Factor)</title>
		<description><![CDATA[As a Senior Medical Writer, I participated in the 2024 annual conference of the American Medical Writers Association (AMWA) to lead a roundtable on protocol QC and keep up to date on trends and best practices in documents related to clinical research. While many of the best attended sessions were related to the current and upcoming use of AI in the field of medical writing, there were plenty of sessions and workshops (as well as discussions during the protocol QC roundtable) that served as reminders that it is still the human aspect of projects that make the greatest impact in the timeliness and quality of a document or project.]]></description>
		<pubDate>Fri, 29 Nov 2024 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/time-crunch-making-the-most-of-what-time-we-have-and-why-the-human-is-still-the-most-important-factor/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/time-crunch-making-the-most-of-what-time-we-have-and-why-the-human-is-still-the-most-important-factor/</guid>
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		<title>SCDM Addresses the Benefits and Challenges of AI</title>
		<description><![CDATA[Members of PROMETRIKA’s Data Management (DM) team attended the recent Society for Clinical Data Management (SCDM) conference, held in Boston this year. This annual conference brings together the global data management community for discussions of the latest developments and challenges faced by DM professionals.]]></description>
		<pubDate>Thu, 31 Oct 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/scdm-addresses-the-benefits-and-challenges-of-ai/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/scdm-addresses-the-benefits-and-challenges-of-ai/</guid>
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	<item>
		<title>Winning Analyses for Composite Endpoints</title>
		<description><![CDATA[The win ratio, introduced by S. Pocock in 2012, is an alternative and practical approach for analyzing composite endpoints. It was originally designed to address challenges faced in cardiovascular (CV) trials, but over the years the win ratio has been utilized in multiple therapeutic areas.]]></description>
		<pubDate>Mon, 30 Sep 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/winning-analyses-for-composite-endpoints/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/winning-analyses-for-composite-endpoints/</guid>
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	<item>
		<title>Protocol to Package Insert: An Efficacy Data Journey</title>
		<description><![CDATA[At PROMETRIKA, we provide biostatistical analysis and regulatory medical writing services to our sponsor companies who have reached the stage of New Drug Application (NDA) or Biologic Licensing Application (BLA) preparation. One of the many crucial documents in these applications is the Package Insert (a.k.a., Prescribing Information or Product Information; PI), the summary of safety and efficacy data on proposed new drugs and biopharmaceuticals (‘drug’ will be used to refer to both hereafter). In the following discussion, I will trace the source and distillation of the efficacy data presented in the PI.]]></description>
		<pubDate>Sat, 31 Aug 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/protocol-to-package-insert-an-efficacy-data-journey/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/protocol-to-package-insert-an-efficacy-data-journey/</guid>
	</item>
	<item>
		<title>When is Automated SDTM Mapping a Benefit?</title>
		<description><![CDATA[This year, PROMETRIKA team members have attended many industry conferences in which the hot topics always seem to be AI and automation of processes. Of course, the innovation cool crowd is excited to jump on board. What has really piqued my attention are the discussions amongst technology vendors about automating SDTM mapping. PROMETRIKA, as a full-service CRO, has a strong focus on biostatistics, statistical, and SDTM programming. Since SDTM mapping is a major part of the programming work that we do, I asked myself “Do we need a new business model for automating SDTM programming?” After hearing multiple viewpoints on the subject, I’ve come away with a list of pros and cons of automating SDTM mapping.]]></description>
		<pubDate>Tue, 23 Jul 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/when-is-automated-sdtm-mapping-a-benefit/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/when-is-automated-sdtm-mapping-a-benefit/</guid>
	</item>
	<item>
		<title>Integrated Systems Enhance Clinical Operations Efficiency</title>
		<description><![CDATA[Throughout the 17 years that PROMETRIKA has offered Clinical Operations services, our goals have been to streamline and maximize efficiency in clinical trials and provide trial management transparency to our sponsors. We have steadily enhanced and integrated our trial data collection and management systems to achieve a fully integrated platform that will provide seamless coordination of EDC, CTMS, and eTMF data.]]></description>
		<pubDate>Sat, 29 Jun 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/integrated-systems-enhance-clinical-operations-efficiency/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/integrated-systems-enhance-clinical-operations-efficiency/</guid>
	</item>
	<item>
		<title>CDISC Advisory Council Task Force Helps Develop New Standards</title>
		<description><![CDATA[As a CDISC Platinum Member, PROMETRIKA has the opportunity to sit on the CDISC Advisory Council (CAC), which plays an important role in shaping CDISC’s development and direction. Platinum Member representatives serve on the CAC, contributing industry expertise and sharing real-world implementation experiences. The CAC represents a cross-section of organizations within the pharma industry; thus, making them a part of the review process for assessing and revising standards. Collectively, the CAC provides the CDISC Executive Team with recommendations that further the CAC mission of “unifying the voices of membership to influence and support CDISC goals.”]]></description>
		<pubDate>Fri, 31 May 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/cdisc-advisory-council-task-force-helps-develop-new-standards/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/cdisc-advisory-council-task-force-helps-develop-new-standards/</guid>
	</item>
	<item>
		<title>Meeting Regulator’s Analysis Needs: CDISC’s Analysis Results Standard</title>
		<description><![CDATA[The accurate analysis and reporting of data is necessary to the evaluation of new treatments for human diseases. Regulatory authorities must weigh the risks with the benefits of treatments in their approval decisions. Often, regulators will ask sponsors to provide information about the analyses, such as the datasets and data selection criteria used to generate the results. The Clinical Data Interchange Standards Consortium (CDISC) has described their newest initiative to standardize analysis results in the form of tables, listings, and figures (TLF) and reporting of data across the industry.]]></description>
		<pubDate>Tue, 30 Apr 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/meeting-regulators-analysis-needs-cdiscs-analysis-results-standard/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/meeting-regulators-analysis-needs-cdiscs-analysis-results-standard/</guid>
	</item>
	<item>
		<title>Understanding and Navigating FDA FAERS E2B(R3) Harmonization</title>
		<description><![CDATA[Drug Safety &#x00026; Pharmacovigilance professionals have long awaited consistency in the manner in which the US Food and Drug Administration (FDA) accepts Individual Case Safety Report (ICSR) submissions. For years, the industry has navigated different submission procedures for FDA compared with other regions, as well as differences between Investigational New Drug (IND) reporting and post-marketing pharmacovigilance reporting. The FDA has been working towards harmonization of ICSR submissions and the final guidance is here! FDA will require that both premarket and post-market safety reports be submitted electronically in the ICH E2B(R3) format, the format that is currently the standard in the EU. Let us explore the current FDA practices, the need for updated processes, timelines for implementation, and what pharmacovigilance professionals need to do to prepare for the change.]]></description>
		<pubDate>Fri, 29 Mar 2024 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/understanding-and-navigating-fda-faers-e2b-r3-harmonization/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/understanding-and-navigating-fda-faers-e2b-r3-harmonization/</guid>
	</item>
	<item>
		<title>Providing a Framework for Patient Data Privacy</title>
		<description><![CDATA[Current European law prohibits businesses from sending personal information about European citizens to companies in the United States (US) without specific contractual obligations to protect the privacy of the information.  However, the current Data Privacy Framework (DPF) allows US companies that are “Certified” under the Framework to import and process personal data of European citizens without these contractual requirements.]]></description>
		<pubDate>Thu, 29 Feb 2024 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/providing-a-framework-for-patient-data-privacy/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/providing-a-framework-for-patient-data-privacy/</guid>
	</item>
	<item>
		<title>Your Pharmacovigilance Partner – One Size Does NOT Fit All</title>
		<description><![CDATA[Pharmacovigilance is one of the most essential functions in the drug development process as it is vital for the continued safety evaluation of a product from the first time it is administered to a person through the post-marketing setting. A Pharmacovigilance program must be set up to detect, assess, understand and prevent adverse effects or other possible drug-related problems, and these activities require extensive documentation and monitoring. The global safety database is the primary tool to support Pharmacovigilance activities as it allows us to review safety cases across an entire investigational program rather than study-by-study. It is the Pharmacovigilance provider’s responsibility to ensure that the database is updated and maintained by inputting individual case safety reports (ICSRs) in a consistent, standardized, and timely manner.]]></description>
		<pubDate>Wed, 31 Jan 2024 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/your-pharmacovigilance-partner-one-size-does-not-fit-all/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/your-pharmacovigilance-partner-one-size-does-not-fit-all/</guid>
	</item>
	<item>
		<title>A Database Programming Intern&#x00027;s Experience at Medidata NEXT</title>
		<description><![CDATA[Medidata NEXT is hosted each year by PROMETRIKA’s technology partner Medidata to help sponsors stay informed on products and solutions for managing clinical trial data. I had the privilege of attending this year’s event in New York City as a PROMETRIKA representative. This was my first-ever industry conference, and Medidata NEXT set the bar high. The venue was in Times Square, and, upon entering the hotel, we were greeted with warm hospitality and a HUGE Medidata NEXT banner. The first event was the introductory keynote, which started with an impactful story of a diabetic mom and her daughter. This introduction served to remind attendees why we do what we do - help people living with medical challenges. The session continued for 2 hours and described the future direction of the Medidata platform.]]></description>
		<pubDate>Tue, 26 Dec 2023 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-database-programming-interns-experience-at-medidata-next/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-database-programming-interns-experience-at-medidata-next/</guid>
	</item>
	<item>
		<title>What&#x00027;s an IDMC?</title>
		<description><![CDATA[Maybe you’ve heard of it before. Another string of letters in the alphabet soup of clinical trials - an IDMC - sometimes also called just a DMC and other times a DSMB. But what does it stand for, what is it, and more importantly, do you need one?]]></description>
		<pubDate>Tue, 14 Nov 2023 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/whats-an-idmc/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/whats-an-idmc/</guid>
	</item>
	<item>
		<title>AMWA 2023 Conference Roundtable: &#x00022;The Well-Rounded Medical Writer: It Goes Beyond Good Writing&#x00022;</title>
		<description><![CDATA[On the surface, a medical writer has a simple calling: communicate medical information and research results clearly to the intended audience. How one achieves this goal is what sets apart a great medical writer. Arriving at a high-quality final document requires planning, clear communication, coordination between team members, and building consensus among stakeholders. These are not directly related to writing per se but are central to the success of our projects, so how does a medical writer learn and hone such skills?]]></description>
		<pubDate>Tue, 14 Nov 2023 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/amwa-2023-conference-roundtable-the-well-rounded-medical-writer-it-goes-beyond-good-writing/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/amwa-2023-conference-roundtable-the-well-rounded-medical-writer-it-goes-beyond-good-writing/</guid>
	</item>
	<item>
		<title>Navigating Common Challenges in Clinical Study Rescues: A Proven Five-Phase Approach for Success</title>
		<description><![CDATA[Clinical trials are rapidly evolving and becoming more complex as they continue to adopt novel technologies and approaches. Factors such as the number of sites and countries involved, study phase, indication, design, procedures, and the number of data sources and data points collected contribute to this complexity, imposing a strain on study execution. Furthermore, in recent years, the biopharmaceutical industry has witnessed changes in business practices and an increase in merger and acquisition activity.]]></description>
		<pubDate>Thu, 19 Oct 2023 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/navigating-common-challenges-in-clinical-study-rescues-a-proven-five-phase-approach-for-success/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/navigating-common-challenges-in-clinical-study-rescues-a-proven-five-phase-approach-for-success/</guid>
	</item>
	<item>
		<title>Experts Share New Challenges at CDISC Europe Interchange</title>
		<description><![CDATA[CDISC standards in clinical trials are the cornerstone of any successful submission to regulatory agencies. While they are “standards,” the structure and the nuances of applying them are continually evolving and changing, making it important to keep up to date in order to provide quality submissions. Here at PROMETRIKA, a full-service CRO, our statistical programmers and biostatisticians engage in continuing education activities by attending webinars, conferences, and training sessions specifically related to CDISC standards in clinical trials.]]></description>
		<pubDate>Tue, 26 Sep 2023 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/experts-share-new-challenges-at-cdisc-europe-interchange/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/experts-share-new-challenges-at-cdisc-europe-interchange/</guid>
	</item>
	<item>
		<title>My Journey to Become a Certified Clinical Data Manager</title>
		<description><![CDATA[January marks the time to develop goals for the upcoming year, and for 2023, I wanted to create a goal outside of project work and pursue individual career development. I became aware of the Certified Clinical Data Manager (CCDM®) program/exam.]]></description>
		<pubDate>Thu, 03 Aug 2023 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/my-journey-to-become-a-certified-clinical-data-manager/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/my-journey-to-become-a-certified-clinical-data-manager/</guid>
	</item>
	<item>
		<title>Excuse me, do you speak Data Management?</title>
		<description><![CDATA[Data Management (DM) and Clinical Operational teams must work hand in hand to properly execute the capture, management, and monitoring of clinical data throughout the entire life cycle of a study; however, the use of different systems, processes, and datasets makes close and effective collaboration a challenge.]]></description>
		<pubDate>Wed, 19 Jul 2023 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/excuse-me-do-you-speak-data-management/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/excuse-me-do-you-speak-data-management/</guid>
	</item>
	<item>
		<title>Implementing Agile Methodologies: Using Trello(tm) to Generate and Optimize Kanban Boards for Recurring SAS Programming Tasks</title>
		<description><![CDATA[In a CRO environment, managing Data Management programming requests presents significant challenges, including prioritization, resource planning, and timely delivery of results. There are a set of recurring tasks, coming from multiple sponsors, with varying frequencies and updates needed. Programmers need a way to keep these tasks organized and to optimize the work flow.]]></description>
		<pubDate>Thu, 01 Jun 2023 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/implementing-agile-methodologies-using-trello-tm-to-generate-and-optimize-kanban-boards-for-recurring-sas-programming-tasks/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/implementing-agile-methodologies-using-trello-tm-to-generate-and-optimize-kanban-boards-for-recurring-sas-programming-tasks/</guid>
	</item>
	<item>
		<title>As Simple as Falling Off a Log? An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain</title>
		<description><![CDATA[Recently, while performing CDISC SDTM mapping for one of our clients, a unique situation arose that involved the DA (Drug Accountability) domain.  This domain tabulates the amount of treatment units dispensed to a subject and the amount returned to gauge dosing compliance for each treated subject and is often collected in a log format.  On the surface, it seems like a fairly straight forward domain, but for this particular example, there were a number of factors that contributed to creating a complex scenario.]]></description>
		<pubDate>Mon, 01 May 2023 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/as-simple-as-falling-off-a-log-an-unusual-case-study-of-mapping-data-into-the-sdtm-da-drug-accountability-domain/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/as-simple-as-falling-off-a-log-an-unusual-case-study-of-mapping-data-into-the-sdtm-da-drug-accountability-domain/</guid>
	</item>
	<item>
		<title>A Day in the Life, Project Manager Edition</title>
		<description><![CDATA[PROMETRIKA, LLC. is a full-service CRO whose clients include national and international biopharmaceutical and medical device companies. In the clinical research environment, even “simple” studies become significant projects spanning multiple companies, teams, investigators, and regulatory bodies. Given such complexity, our Project Managers (PMs) are critical to effective management of all services and functions that contribute to the success of a project.]]></description>
		<pubDate>Sat, 01 Apr 2023 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-project-manager-edition/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-project-manager-edition/</guid>
	</item>
	<item>
		<title>Continued Learning and Development at PHUSE 2023</title>
		<description><![CDATA[I had the opportunity to attend the 2023 PHUSE conference and explore the latest advancements in clinical data analysis through engaging workshops and presentations. Key topics included CDISC Analysis Results Standards, SDTM mapping recommendation engines, incremental automation using machine learning, and Leadership and professional development. The conference provided valuable insights into emerging trends and technologies that are shaping the future of clinical research.]]></description>
		<pubDate>Wed, 01 Mar 2023 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/continued-learning-and-development-at-phuse-2023/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/continued-learning-and-development-at-phuse-2023/</guid>
	</item>
	<item>
		<title>Decentralized Clinical Trials, Part 2 - The Current Landscape</title>
		<description><![CDATA[Over the past 15 – 20 years, projected peak sales and return on investment (ROI) of new drugs has been shrinking (source: Statista and Deloitte Centre for Health Solutions). To offset this, pharmaceutical companies are pushing to get more drugs to market and multiple indications for each agent.]]></description>
		<pubDate>Tue, 14 Feb 2023 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/decentralized-clinical-trials-part-2-the-current-landscape/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/decentralized-clinical-trials-part-2-the-current-landscape/</guid>
	</item>
	<item>
		<title>Decentralized Clinical Trials, Part 1 – Its History (and Future?)</title>
		<description><![CDATA[Decentralized clinical trials (DCT) seems to have burst on to the scene in just the last few years, so it is easy to get swept up into how we can best implement them into our clinical trials. However, it is worth examining the past of this supposedly “new” method of conducting clinical trials.]]></description>
		<pubDate>Tue, 31 Jan 2023 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/decentralized-clinical-trials-part-1-its-history-and-future/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/decentralized-clinical-trials-part-1-its-history-and-future/</guid>
	</item>
	<item>
		<title>Certification for European Regulations: More Than &#x00022;Familiar&#x00022; With GDPR</title>
		<description><![CDATA[The European Parliament and the Council of the European Union approved the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/279) which became enforceable on May 25, 2018.  Because personal information, including health information, is collected during clinical trials, knowing and understanding the GDPR is critical for running clinical trials in the European Union.  Penalties for infringements of specific provisions of the Regulation can reach up to 4% of a company’s total worldwide turnover (i.e., gross revenue).]]></description>
		<pubDate>Wed, 28 Dec 2022 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/certification-for-european-regulations-more-than-familiar-with-gdpr/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/certification-for-european-regulations-more-than-familiar-with-gdpr/</guid>
	</item>
	<item>
		<title>Adjustment of Covariates in Randomized Trials</title>
		<description><![CDATA[PROMETRIKA team members make continuous learning a priority. As a statistician, it is important to keep up-to-date with the FDA’s current thinking on analytic approaches applied in clinical trials. In May 2021, the FDA published a draft guidance for industry, “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products,” which provides recommendations for use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to superiority trials and noninferiority trials.  I share some highlights and insights on this topic below.]]></description>
		<pubDate>Mon, 28 Nov 2022 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/adjustment-of-covariates-in-randomized-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/adjustment-of-covariates-in-randomized-trials/</guid>
	</item>
	<item>
		<title>Estimands Framework in Clinical Trials: Choosing the Best Strategy</title>
		<description><![CDATA[All team members at PROMETRIKA take responsibility for remaining well versed in the changes in regulations and trends that impact their work. As a biostatistician at PROMETRIKA, I recently attended the American Statistical Association annual Biophamaceutical Section Regulatory-Industry Statistics conference where we discussed the addendum to the E9 (R1) Statistical Principles for Clinical Trials titled “Estimands and Sensitivity Analysis in Clinical Trials.”  The addendum introduces the Estimands Framework and strategies for selecting an estimand. PROMETRIKA invites you to explore this addendum and learn about the estimand strategies put forth in this update. PROMETRIKA can assist you with these and other clinical trial needs.]]></description>
		<pubDate>Fri, 28 Oct 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/estimands-framework-in-clinical-trials-choosing-the-best-strategy/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/estimands-framework-in-clinical-trials-choosing-the-best-strategy/</guid>
	</item>
	<item>
		<title>Risk-based Monitoring and the Monitor&#x00027;s Roles - Part 2</title>
		<description><![CDATA[“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”]]></description>
		<pubDate>Fri, 16 Sep 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/optimizing-tlf-generation-titles-and-footnotes-applying-a-new-idea-to-a-basic-approach-2/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/optimizing-tlf-generation-titles-and-footnotes-applying-a-new-idea-to-a-basic-approach-2/</guid>
	</item>
	<item>
		<title>Risk-based Monitoring and the Monitor&#x00027;s Roles - Part 1</title>
		<description><![CDATA[“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”]]></description>
		<pubDate>Wed, 31 Aug 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/optimizing-tlf-generation-titles-and-footnotes-applying-a-new-idea-to-a-basic-approach-1/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/optimizing-tlf-generation-titles-and-footnotes-applying-a-new-idea-to-a-basic-approach-1/</guid>
	</item>
	<item>
		<title>Optimizing TLF Generation: Titles and Footnotes, Applying a New Idea to a Basic Approach</title>
		<description><![CDATA[PROMETRIKA’s statistical programming team is developing methods to enhance the efficiency and maintain high quality of table development while managing changes in the data and the requirements as table programming is in progress.]]></description>
		<pubDate>Sun, 31 Jul 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/optimizing-tlf-generation-titles-and-footnotes-applying-a-new-idea-to-a-basic-approach/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/optimizing-tlf-generation-titles-and-footnotes-applying-a-new-idea-to-a-basic-approach/</guid>
	</item>
	<item>
		<title>Applying Agile Methodology to Statistical Programming</title>
		<description><![CDATA[In any industry, there are various methods for approaching task deadlines to remain within the timeline. It is vital to choose a method that can accommodate challenges faced during the project and reduce time or at least help mitigate any delays. Effective task management is the key to maintaining the project budget and addressing other challenges.]]></description>
		<pubDate>Thu, 30 Jun 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/applying-agile-methodology-to-statistical-programming/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/applying-agile-methodology-to-statistical-programming/</guid>
	</item>
	<item>
		<title>Enhancing Inclusion in Clinical Trials With a Patient Centered Approach</title>
		<description><![CDATA[Drug development and clinical research methods evolve continuously through establishment of new regulations and through adaptations to changes in treatment accessibility, technology, evolving knowledge in biology, and appearance of new diseases. 

Patient-centric trials, in which the perspective of the patient is considered in study design and performance, is one such new approach in clinical research that primarily focuses on reducing patient burden. ]]></description>
		<pubDate>Tue, 31 May 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/enhancing-inclusion-in-clinical-trials-with-a-patient-centered-approach/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/enhancing-inclusion-in-clinical-trials-with-a-patient-centered-approach/</guid>
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		<title>The Investigator Responsibilities in IND Safety Reporting</title>
		<description><![CDATA[An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.]]></description>
		<pubDate>Sat, 30 Apr 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-investigator-responsibilities-in-ind-safety-reporting/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-investigator-responsibilities-in-ind-safety-reporting/</guid>
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		<title>The Sponsor’s Responsibilities in IND Safety Reporting</title>
		<description><![CDATA[An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.]]></description>
		<pubDate>Thu, 31 Mar 2022 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-sponsors-responsibilities-in-ind-safety-reporting/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-sponsors-responsibilities-in-ind-safety-reporting/</guid>
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	<item>
		<title>Checklists Can be a Piece of Cake</title>
		<description><![CDATA[Checklists. Some people hate them; some people love them. There have been whole books written about them. Some checklist fans say they live by their checklists. Cynics may see checklists as long, tedious, ineffective, bothersome, or just plain wrong. And, well, that’s sometimes true.

So what makes a good and effective checklist?]]></description>
		<pubDate>Mon, 28 Feb 2022 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/checklists-can-be-a-piece-of-cake/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/checklists-can-be-a-piece-of-cake/</guid>
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	<item>
		<title>CDISC SDTM Certification</title>
		<description><![CDATA[I can actually say that I have been working in the Clinical Trials industry since the last century.  I started as a database programmer, part of data management in a large (now huge) CRO.  In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse.  We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us.  Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor.  With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?]]></description>
		<pubDate>Mon, 31 Jan 2022 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/cdisc-sdtm-certification/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/cdisc-sdtm-certification/</guid>
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	<item>
		<title>Adaptive Design Options for Dose Finding Trials</title>
		<description><![CDATA[The objective of phase 1 dose-finding studies is to determine the maximum tolerated dose (MTD), defined as the highest dose at which a pre-specified proportion of subjects experience a dose limiting toxicity (DLT). Ideally, the trial design would not only be easy to implement but also efficient and ethical. In recent years, several statistical models for adaptive trial designs have emerged.]]></description>
		<pubDate>Thu, 23 Dec 2021 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/adaptive-design-options-for-dose-finding-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/adaptive-design-options-for-dose-finding-trials/</guid>
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	<item>
		<title>Source Document Verification and Source Data Review: What&#x00027;s the Difference and Why We Should Care</title>
		<description><![CDATA[The thinking on monitoring of clinical studies has been changing over the past several years, so now is a good time to reassess the place of SDV and SDR in the operation of clinical trials.]]></description>
		<pubDate>Mon, 22 Nov 2021 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/source-document-verification-and-source-data-review-whats-the-difference-and-why-we-should-care/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/source-document-verification-and-source-data-review-whats-the-difference-and-why-we-should-care/</guid>
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		<title>A Case for Binary Causality in Clinical Trials</title>
		<description><![CDATA[Related, Not Related, Likely, Possibly Related, Unlikely Related, Certain, Definitely, Unassessable, Unknown, Probably Related…if you recognize these terms, then there is a reasonable possibility you are familiar with what the Drug Safety and Pharmacovigilance world refers to as the causality assessment.]]></description>
		<pubDate>Fri, 29 Oct 2021 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-case-for-binary-causality-in-clinical-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-case-for-binary-causality-in-clinical-trials/</guid>
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		<title>The Trial Master File Paradox</title>
		<description><![CDATA[One of the great ironies that gives me chuckle in my day-to-day work is the seeming paradox that one of the purposes of the Trial Master File (TMF) is to REDUCE documentation, while in reality, the amount of documentation that goes into a TMF can honestly feel overwhelming.]]></description>
		<pubDate>Tue, 28 Sep 2021 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-trial-master-file-paradox/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-trial-master-file-paradox/</guid>
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		<title>A Day in the Life of a CRA: Monitoring at the Beginning of the New Normal – Part 2</title>
		<description><![CDATA[In March of 2020, when much of the country began to impose lockdowns and restrictions on public contact due to COVID‑19, I was in New York City on the monitoring trip noted in my previous blog. In the ensuing months, the nature of clinical trial monitoring was mostly redefined in an attempt to continue crucial studies and participant care. The following are some of my observations and lessons learned in the aftermath of that experience.]]></description>
		<pubDate>Fri, 20 Aug 2021 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-of-a-cra-monitoring-at-the-beginning-of-the-new-normal-part-2/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-of-a-cra-monitoring-at-the-beginning-of-the-new-normal-part-2/</guid>
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	<item>
		<title>Revolutionizing the Approach to Treating Cancer: Then and Today - Part 3</title>
		<description><![CDATA[In 2021, FDA has so far approved six antibodies against PD-1 or PD ligand 1 (PD-L1) for more than 75 indications. Ipilimumab remains the only FDA approved anti-CTLA-4 antibody, in melanoma indications and, in combination with nivolumab (an anti-PD‑1 antibody), in a number of other indications.]]></description>
		<pubDate>Thu, 22 Jul 2021 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/revolutionizing-the-approach-to-treating-cancer-then-and-today-part-3/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/revolutionizing-the-approach-to-treating-cancer-then-and-today-part-3/</guid>
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	<item>
		<title>Revolutionizing the Approach to Treating Cancer: Then and Today - Part 2</title>
		<description><![CDATA[Basic research in the 1990’s showed that antibodies aimed at a cell surface marker called cytotoxic T-lymphocyte antigen 4 (CTLA-4) stimulated an immune response that resulted in the killing of the tumor cells. Another cell marker, programmed death-1 (PD-1), was found to have the ability to prevent the immune system from killing cancer cells. These discoveries led to the development of cancer therapy using inhibition of negative immune regulation.]]></description>
		<pubDate>Thu, 24 Jun 2021 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/revolutionizing-the-approach-to-treating-cancer-then-and-today-part-2/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/revolutionizing-the-approach-to-treating-cancer-then-and-today-part-2/</guid>
	</item>
	<item>
		<title>Revolutionizing the Approach to Treating Cancer: Then and Today - Part 1</title>
		<description><![CDATA[We knew that immunotherapy finally had a breakthrough when James Allison and Tasuku Honjo received the Nobel Prize in Physiology or Medicine in 2018 for “discovery of cancer therapy by inhibition of negative immune regulation.”]]></description>
		<pubDate>Sat, 01 May 2021 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/revolutionizing-the-approach-to-treating-cancer-then-and-today/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/revolutionizing-the-approach-to-treating-cancer-then-and-today/</guid>
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	<item>
		<title>A Day in the Life of a CRA: Monitoring at the Beginning of the New Normal – Part 1</title>
		<description><![CDATA[I was in New York City on March 1, 2020 when the news reported that the first positive case of COVID-19 had been identified in that state. A pharmaceutical company seeking accelerated approval for one of their products had selected PROMETRIKA to re-monitor their study’s efficacy data after a recommendation from the European Medicines Agency. I ended up traveling to NYC on short notice after learning about an urgent need for a monitoring visit at one of the oldest and largest teaching hospitals in the United States. While leading a two-day monitoring visit at that hospital, it was announced that a coronavirus patient had been admitted to their emergency room for the first time. The research staff in my vicinity were anxious about this invisible, contagious, mystery virus, and it had just been confirmed that their colleagues were interacting with a patient that had been exposed to it. I walked back to the hotel that night and didn’t think anything of it when the song,]]></description>
		<pubDate>Thu, 29 Apr 2021 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-of-a-cra-monitoring-at-the-beginning-of-the-new-normal-part-1/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-day-in-the-life-of-a-cra-monitoring-at-the-beginning-of-the-new-normal-part-1/</guid>
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	<item>
		<title>Moving Day: Best Practices for Implementing a New eTMF System</title>
		<description><![CDATA[So, your organization has made the decision to transition to a new eTMF system. Congratulations on taking this step! Depending on your organization and your role, you may or may not have been part of the decision-making process for choosing the system. You may be somewhat familiar with the system or encountering it for the first time. Either way, now that the ink on the contract is dry, it is time to begin making the most of your new eTMF.]]></description>
		<pubDate>Mon, 01 Mar 2021 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/moving-day-best-practices-for-implementing-a-new-etmf-system/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/moving-day-best-practices-for-implementing-a-new-etmf-system/</guid>
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	<item>
		<title>Applying the Goldilocks Principle to Data Analytics Technology</title>
		<description><![CDATA[Buzzwords like “analytics” and “visualization” have been used in the clinical trial space since the ability to collect massive quantities of clinical trial data became a reality. Everyone wants the instant gratification of real-time trend detection, and software developers have responded in kind by providing a dizzying array of analytics options. How do you make an informed decision about which option is the right fit?]]></description>
		<pubDate>Sun, 28 Feb 2021 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/applying-the-goldilocks-principle-to-data-analytics-technology/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/applying-the-goldilocks-principle-to-data-analytics-technology/</guid>
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	<item>
		<title>Rampant Misuse of the Word “De-Identified”</title>
		<description><![CDATA[Having worked in the world of clinical research for 15 years, I can’t help but be baffled by the rampant misuse of the word “de-identified” as it relates to the classification of clinical data sets.  In the United States, “the HIPAA Privacy Rule provides federal protections for personal health information [PHI] held by covered entities and gives patients an array of rights with respect to that information.”  De-identified health information is not PHI and thus is not protected by HIPAA.

It’s a common misconception that if you remove patients’ names from a set of clinical data, then it becomes de-identified and is no longer governed by HIPAA.  However, to make a set of clinical data truly de-identified, you must remove much more than just the patients’ names. ]]></description>
		<pubDate>Tue, 12 Jan 2021 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/rampant-misuse-of-the-word-de-identified/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/rampant-misuse-of-the-word-de-identified/</guid>
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		<title>Putting Patients First: Taking Trials and Technology Home</title>
		<description><![CDATA[Home visits as part of clinical research have accelerated in recent years as we strive to find the right balance between facilitating study participation while accommodating participant’s busy everyday lives. Clinical trials in rare diseases are even more challenging than trials in other diseases due to a number of factors:

Small number of eligible trial participants
	Complicated by heterogeneity among rare disease patients
	Most have no cure and manifest at a young age
	Less than 10% of rare diseases have a specific treatment
	Many have other debilitating conditions / physical limitations making it difficult to attend frequent study visits
The combination of home study visits and the right technology removes barriers to optimal patient recruitment, compliance and retention.]]></description>
		<pubDate>Tue, 08 Dec 2020 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/putting-patients-first-taking-trials-and-technology-home/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/putting-patients-first-taking-trials-and-technology-home/</guid>
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	<item>
		<title>Tipping Point Analyses in Missing Data Imputation</title>
		<description><![CDATA[This is the last in a series of three posts on missing data imputation.  In the first post, we reviewed the underlying assumptions and limitations of single imputation methods, in particular, last observation carried forward (LOCF).  In the second post, we considered more sophisticated data imputation methods for longitudinal data, Mixed Models for Repeated Measures (MMRM) and Multiple Imputation (MI).  An important assumption for both MMRM and MI is that the data are ‘missing at random’ (MAR), if not ‘missing completely at random’ (MCAR).  But what if this assumption is not true for all the missing data?]]></description>
		<pubDate>Thu, 05 Nov 2020 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/tipping-point-analyses-in-missing-data-imputation/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/tipping-point-analyses-in-missing-data-imputation/</guid>
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	<item>
		<title>A thought provoking discussion by leading experts on review, accessibility and monitoring of COVID-19 Vaccines</title>
		<description><![CDATA[Four former FDA commissioners and Dr. Peter Marks, the FDA official responsible for the oversight of vaccines, shared their thoughts on the FDA’s role in ensuring the safety and effectiveness of COVID-19 vaccines under extraordinary circumstances, in the ongoing pandemic.

The event, entitled “Safe and Effective COVID-19 Vaccination: The Path from Here” was hosted by the Duke-Margolis Center for Health Policy on September 10, 2020.  The speakers discussed the mountain of challenges across all aspects of developing and distributing a vaccine under expedited timelines: testing, reviewing, approving, monitoring safety events, and the logistics of distribution for vaccines that may require specialized storage conditions.]]></description>
		<pubDate>Wed, 07 Oct 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-thought-provoking-discussion-by-leading-experts-on-review-accessibility-and-monitoring-of-covid-19-vaccines/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-thought-provoking-discussion-by-leading-experts-on-review-accessibility-and-monitoring-of-covid-19-vaccines/</guid>
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	<item>
		<title>Invest in Your Laboratory Information Success</title>
		<description><![CDATA[All clinical data managers (CDMs) are familiar with the difficulties of ensuring that laboratory values are compared to the local laboratory normal ranges that were valid at the time of the measurement. In studies with many local laboratories, and in global studies, the same test may be reported in different units across the study. To help alleviate these problems, some studies use central laboratories. Yet there are some problems with this approach as well. Shipping samples from study sites to the central laboratory incurs extra cost and runs the risk that the sample will be unusable when it arrives. ]]></description>
		<pubDate>Mon, 14 Sep 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/invest-in-your-laboratory-information-success/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/invest-in-your-laboratory-information-success/</guid>
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	<item>
		<title>Remote Healthcare: One Woman’s About-Face</title>
		<description><![CDATA[Remote interactions—often termed eClinical Technology—are making their way into clinical trials. Precipitated by the COVID-19 pandemic, we have seen an uptick in the adoption of televisits, remote monitoring, and eConsent in clinical trials. ]]></description>
		<pubDate>Tue, 25 Aug 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/remote-healthcare-one-womans-about-face/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/remote-healthcare-one-womans-about-face/</guid>
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	<item>
		<title>Presenting &#x00022;Creating Harmonious SDTM Domains&#x00022;</title>
		<description><![CDATA[Last October, Susan Boquist, Associate Director, Statistical Programming, traveled to CDISC International Interchange in San Diego, California to present the poster, “Creating Harmonious SDTM Domains”.  The poster was created in collaboration with Principal Statistical Programmers: Elena Prosekova, Natalia Quinn and Sofia Tyryshkina. 

Mapping raw data into standardized, tabulated data sets can be a daunting task to undertake, especially if one has not done it before.  Even seasoned mappers could use the help of some additional ideas and tips.  The poster shared the authors’ thoughts, suggestions and examples to help turn a cacophony of raw data into a standardized symphony that will flow into analysis.]]></description>
		<pubDate>Wed, 12 Aug 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/presenting-creating-harmonious-sdtm-domains/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/presenting-creating-harmonious-sdtm-domains/</guid>
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	<item>
		<title>Clinical Data Experts &#x00022;Meet&#x00022; in Berlin</title>
		<description><![CDATA[Due to the worldwide pandemic, the CDISC European Interchange, originally scheduled to take place in person in Berlin, Germany, was presented completely online. Susan Boquist, Associate Director, Statistical Programming, took advantage of the accessibility and logged in at 3:00 am her time both mornings. Though it may have become an April Fool’s Day to remember, with only a few weeks’ notice, the organizers were able to make the format transformation flawlessly. The conference schedule was consolidated into one track. A networking app was employed to allow for attendees to easily communicate with each other, ask questions of the presenters, and view and vote on the poster presentations. Training and workshops were rescheduled for another time. It was so successful that everyone hopes the organizers will consider adding a virtual option for future conferences. ]]></description>
		<pubDate>Tue, 28 Jul 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/clinical-data-experts-meet-in-berlin/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/clinical-data-experts-meet-in-berlin/</guid>
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	<item>
		<title>Building Relationships: Increasing Site and Subject Engagement</title>
		<description><![CDATA[Most clinical researchers are motivated by the desire to improve patient health and drive innovation in healthcare. To optimize health system performance, Bodenheimer and Sinsky, building on the work of Donald Berwick, proposed the quadruple aim as a means to improve health system performance. The quadruple aim focuses on (1) enhancing the patient experience, (2) improving population health, (3) reducing costs, and (4) improving the work life of health care providers, including clinicians and staff. Clinical research should follow the quadruple aim to improve the design and conduct of clinical trials.]]></description>
		<pubDate>Thu, 25 Jun 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/building-relationships-increasing-site-and-subject-engagement/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/building-relationships-increasing-site-and-subject-engagement/</guid>
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	<item>
		<title>Medical Imaging Made Easy: A Clinical Project Manager&#x00027;s Perspective</title>
		<description><![CDATA[As a Clinical Project Manager (CPM), one of my primary roles on a project is to ensure that the clinical and data management stakeholders have the tools necessary to streamline safety review and data quality review on a project. The CPM’s first action should be to complete a Stakeholder Analysis. According to the Project Management Body of Knowledge (PMBOK), Fifth Edition, released by the Project Management Institute (PMI), the key processes in Stakeholder Management are:     
                                                     1. Identify Stakeholders
                                                     2. Plan Stakeholder Management
                                                     3. Manage Stakeholder Engagement
                                                     4. Control Stakeholder Engagement
Knowing who the stakeholders are,]]></description>
		<pubDate>Tue, 19 May 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/medical-imaging-made-easy-a-clinical-project-managers-perspective/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/medical-imaging-made-easy-a-clinical-project-managers-perspective/</guid>
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	<item>
		<title>Analyzing &#x00027;Missing at Random&#x00027; Data</title>
		<description><![CDATA[In a previous post on missing data imputation, we reviewed the underlying assumptions and limitations of last observation carried forward (LOCF). This method was widely used in the past because of its straightforward application, ease of understanding, and often incorrect assumption that it is a conservative approach. Over the years, more sophisticated data imputation methods for longitudinal data have been developed that have advantages over the single imputation methods, such as LOCF, baseline observation carried forward (BOCF) or worst observation carried forward (WOCF).  We will briefly review two of these methods, mixed models for repeated measures (MMRM) and multiple imputation (MI).]]></description>
		<pubDate>Mon, 20 Apr 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/analyzing-missing-at-random-data/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/analyzing-missing-at-random-data/</guid>
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	<item>
		<title>Closing the Real-World Evidence Gap: Pragmatic Clinical Trials &#x00026; Observational Studies</title>
		<description><![CDATA[I recently served as the moderator for MassBio’s forum on “Closing the Real-World Evidence Gap: Pragmatic Clinical Trials &#x00026; Observational Studies.” This lively and informative discussion was led by a panel of industry leaders, which included Robert Califf, MD, MACC, Head of Medical Strategy and Policy, Verily Life Sciences and Google Health; Jane Liang White, ScD, Senior Director, Statistical Group Lead for Oncology/Hematology Franchise at Pfizer; and Rebecca Miksad, MD, MPH, Senior Medical Director of Flatiron Health. ]]></description>
		<pubDate>Tue, 31 Mar 2020 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/closing-the-real-world-evidence-gap/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/closing-the-real-world-evidence-gap/</guid>
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		<title>SAD or MAD But Not Alone: Medical Writing for Small Biotechs</title>
		<description><![CDATA[Emerging biotech companies must master many challenges in bringing a product to market. Even the acronyms common to early development, like IND (Investigational New Drug Application), SAD (single ascending dose), and MAD (multiple ascending dose) imply that a company must know how their treatment impacts the body, how to analyze study results, and how to express their findings to regulatory authorities. The expertise of medical writers is valuable in helping an emerging biotech reach its drug development goals.]]></description>
		<pubDate>Tue, 18 Feb 2020 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/sad-or-mad-but-not-alone-medical-writing-for-small-biotechs/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/sad-or-mad-but-not-alone-medical-writing-for-small-biotechs/</guid>
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	<item>
		<title>Giving Back with Tutoring Plus</title>
		<description><![CDATA[Last summer, PROMETRIKA partnered with Tutoring Plus of Cambridge, a local nonprofit that provides after-school tutoring and mentoring programs for Cambridge youths. Tutoring Plus was founded in 1964 and today serves about 175 students, with support of nearly 150 volunteers. Programs include one-on-one tutoring, as well as enrichment programs for topics ranging from writing to engineering. The programs are always free of cost to the students’ families.]]></description>
		<pubDate>Fri, 17 Jan 2020 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/giving-back-with-tutoring-plus/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/giving-back-with-tutoring-plus/</guid>
	</item>
	<item>
		<title>PM Considerations for NDA/MAA Submissions</title>
		<description><![CDATA[PROMETRIKA’s portfolio of services includes extensive work in New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs). In the company’s 16 year history, PROMETRIKA team members have collaborated on 19 NDAs and MAAs. Our data managers, statistical programmers, biostatisticians, and medical writers have designed, implemented, and reported on the clinical submission data in indications such as oncology, CNS/psychiatry, renal disease, respiratory disease/allergy, and several rare diseases. PROMETRIKA’s NDA/MAA Project Managers (PMs) have developed the tools and skills necessary to successfully manage the study level team and the subject matter experts to complete submission projects with high-quality, on-time deliverables.]]></description>
		<pubDate>Wed, 18 Dec 2019 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/pm-considerations-for-nda-maa-submissions/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/pm-considerations-for-nda-maa-submissions/</guid>
	</item>
	<item>
		<title>Current Trends in Global Clinical Trials</title>
		<description><![CDATA[Hwang et al.[i] completed a study looking at 640 phase 3 trials investigating novel therapies and found that 54% of these projects failed in clinical development; 57% of the failures were due to inadequate drug efficacy.  This means that 43% of the projects that failed were due to reasons other than the efficacy of the drug.  It is likely that many of these failures were due to operational deficiencies.  It is important to consider that a Sponsor’s investment in a trial is not only the investment made for the phase in which the project fails, but all investments from discovery leading up to the failure.

 

 ]]></description>
		<pubDate>Tue, 26 Nov 2019 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/trends-in-global-clinical-trials/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/trends-in-global-clinical-trials/</guid>
	</item>
	<item>
		<title>How Risk Based Monitoring Fits into an Overall Clinical Development Quality Management Approach</title>
		<description><![CDATA[In recent years, efforts to streamline clinical research activities while improving subject safety and data integrity have included risk based monitoring (RBM). As recently as May 2019, the International Council for Harmonisation (ICH) proposed revisions to its General Considerations for Clinical Studies (E8) guideline. Section 3 of E8 (R1) stresses the importance of managing the quality of safety measures and data collection as part of an entire Quality Plan in a clinical program and its studies. This effort is called Risk-Based Quality Management (RBQM).]]></description>
		<pubDate>Thu, 31 Oct 2019 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/risk-based-monitoring/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/risk-based-monitoring/</guid>
	</item>
	<item>
		<title>Considerations for Missing Data Imputation</title>
		<description><![CDATA[Methods for addressing missing data in longitudinal studies have been written about extensively for many years, but the focus has increased more in the past decade with the publication of the EMA Guideline on Missing Data in Confirmatory Clinical Trials and the National Research Council’s treatise on The Prevention and Treatment of Missing Data in Clinical Trials both in 2010 and the release of ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials in 2017.  Case studies and new methodologies addressing the handling of missing data are published on a regular basis.  Yet for all the attention this topic receives, and perhaps because of the abundance of information on this topic, clinical researchers often do not know what data imputation approach is best for their particular clinical trial. ]]></description>
		<pubDate>Fri, 27 Sep 2019 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/missing-data-imputation/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/missing-data-imputation/</guid>
	</item>
	<item>
		<title>Internships: The Ultimate Win-Win</title>
		<description><![CDATA[Since its founding in 2003, PROMETRIKA has provided paid internship positions to about 30 young women and men in a variety of disciplines, either directly or through relationships with colleges and universities. Historically our interns have been mostly from Massachusetts institutions including Boston University, Wentworth Institute of Technology, Harvard University, Smith College, UMass Lowell, and Emerson College. While a majority of our interns have been graduate students working toward their Master’s or doctorate in biostatistics and other public health disciplines, we have recently expanded our program to include undergraduate students in a variety of disciplines such as biological sciences, mathematics, and computer science. ]]></description>
		<pubDate>Thu, 29 Aug 2019 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/internships2019/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/internships2019/</guid>
	</item>
	<item>
		<title>Protocol to Package Insert: The Safety Edition</title>
		<description><![CDATA[The development of the Package Insert (PI), also known as the Product Information, Prescribing/Prescriber’s Information, or simply “the Label,” is a long, complex process typically managed by a regulatory professional. It is a collaborative document, incorporating contributions from chemistry, toxicology, medical/clinical, biostatistical, writing, and regulatory professionals. Drawing from experience on a recent project, I would like to focus this installment of Protocol to Package Insert on the derivation of the clinical safety data that appear in the PI.]]></description>
		<pubDate>Wed, 24 Jul 2019 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/protocol-to-pi-safety-edition/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/protocol-to-pi-safety-edition/</guid>
	</item>
	<item>
		<title>2019 AICROS Annual Meeting: Collaborating to Bring Clinical Research to the World</title>
		<description><![CDATA[AICROS, the Association of International Clinical Research Organizations, is a consortium of small to mid-size CROs that collaborate to provide clinical research services to the biotechnology, pharmaceutical and device industries worldwide. PROMETRIKA joined AICROS in 2018 and on May 29 -30th, PROMETRIKA’s Head of Clinical Operations, Heather Paden, attended the AICROS Annual meeting, which took place in Kaunas, Lithuania.]]></description>
		<pubDate>Thu, 27 Jun 2019 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/2019-aicros-annual-meeting-collaborating-to-bring-clinical-research-to-the-world/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/2019-aicros-annual-meeting-collaborating-to-bring-clinical-research-to-the-world/</guid>
	</item>
	<item>
		<title>Do you BIMO?</title>
		<description><![CDATA[Quick – What is BIMO? Is it a flying superhero? Is it an energy drink? Is it the next reality TV show? (Well, it is reality.) Here is a brief overview of BIMO and how it came to be.]]></description>
		<pubDate>Tue, 21 May 2019 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/do-you-bimo/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/do-you-bimo/</guid>
	</item>
	<item>
		<title>Illuminating Results from a Natural History Study</title>
		<description><![CDATA[Recently, our own Nicole LaVallee, PhD (Director of Biostatistics) and Miganush Stepanians, PhD (President &#x00026; CEO and senior advisor in Biostatistics) collaborated with the scientists at Boston Children’s Hospital on analyses of the Angelman Syndrome Natural History Study. The results of this collaborative effort were published in the American Journal of Medical Genetics.]]></description>
		<pubDate>Wed, 17 Apr 2019 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/illuminating-results-from-natural-history-study/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/illuminating-results-from-natural-history-study/</guid>
	</item>
	<item>
		<title>Observations from Rare Disease Day 2019</title>
		<description><![CDATA[Last Thursday saw the 12th annual celebration of Rare Disease Day – an international day of recognition when hundreds of events take place around the world.]]></description>
		<pubDate>Tue, 05 Mar 2019 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/observations-from-rare-disease-day-2019/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/observations-from-rare-disease-day-2019/</guid>
	</item>
	<item>
		<title>Highlights from the 2018 CDISC US Interchange</title>
		<description><![CDATA[The annual CDISC US Interchange brought enthusiasts of standards in clinical trials together in Bethesda, MD in October 2018.]]></description>
		<pubDate>Wed, 23 Jan 2019 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-the-2018-cdisc-us-interchange/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/highlights-from-the-2018-cdisc-us-interchange/</guid>
	</item>
	<item>
		<title>A Wealth of Insight for Biostatisticians at Annual Workshop</title>
		<description><![CDATA[I was very excited to attend the ASA Biopharmaceutical Section Regulatory-Industry Statistics (ASA-FDA) workshop in Washington D.C. in September. It reminded me why I love being a clinical trials statistician and particularly why I enjoy working at a small CRO.]]></description>
		<pubDate>Fri, 21 Dec 2018 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-wealth-of-insight-for-biostatisticians-at-annual-workshop/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-wealth-of-insight-for-biostatisticians-at-annual-workshop/</guid>
	</item>
	<item>
		<title>ASA-FDA 2018: ICH E9 (R1), Estimands, Intercurrent Events, and Sensitivity Analysis</title>
		<description><![CDATA[The American Statistical Association (ASA) Biopharmaceutical Section Regulatory-Industry Statistics Workshop (ASA-FDA) is held in Washington D.C. annually.]]></description>
		<pubDate>Tue, 27 Nov 2018 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/asa-fda-2018-ich-e9-r1-estimands-intercurrent-events-and-sensitivity-analysis/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/asa-fda-2018-ich-e9-r1-estimands-intercurrent-events-and-sensitivity-analysis/</guid>
	</item>
	<item>
		<title>American Kidney Fund Pairing for Prevention</title>
		<description><![CDATA[PROMETRIKA was honored to be invited back to sponsor the American Kidney Fund’s Pairing for Prevention fundraising event.]]></description>
		<pubDate>Wed, 31 Oct 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/american-kidney-fund-pairing-for-prevention/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/american-kidney-fund-pairing-for-prevention/</guid>
	</item>
	<item>
		<title>Celebrating 15 Years of Excellence</title>
		<description><![CDATA[On Wednesday, September 19, 2018, PROMETRIKA held a reception for our clients and colleagues to celebrate the company’s milestone achievement of 15 years of excellence in business.]]></description>
		<pubDate>Wed, 26 Sep 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/celebrating-15-years-of-exellence/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/celebrating-15-years-of-exellence/</guid>
	</item>
	<item>
		<title>mHealth Strategies for Rare Disease Studies</title>
		<description><![CDATA[Companies that specialize in drugs for the treatment of rare diseases face a number of unique challenges during the development lifecycle of their products.]]></description>
		<pubDate>Tue, 28 Aug 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/mhealth-strategies-for-rare-disease-studies/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/mhealth-strategies-for-rare-disease-studies/</guid>
	</item>
	<item>
		<title>FDA Addresses the Challenges of eSource Utilization</title>
		<description><![CDATA[PROMETRIKA Clinical Operations was recently faced with the challenge of initiating the first clinical trial for a specialized research group at a large, academic, world-renowned, oncology research hospital in the US.]]></description>
		<pubDate>Mon, 30 Jul 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/2018-07-30-fda-addresses-challenges-esource-utilization/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/2018-07-30-fda-addresses-challenges-esource-utilization/</guid>
	</item>
	<item>
		<title>Where Did the Eyeball Go? A look at RaveX</title>
		<description><![CDATA[PROMETRIKA is pleased to announce that we have successfully implemented RaveX in our Data Management department.]]></description>
		<pubDate>Tue, 26 Jun 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/where-did-the-eyeball-go/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/where-did-the-eyeball-go/</guid>
	</item>
	<item>
		<title>Must We Fast Before Lipid Measurements?</title>
		<description><![CDATA[For decades, fasting for 8 to 12 hours prior to blood draw has been the recommended guideline for measurement of lipid profiles.  But does fasting have a clinically significant outcome on the results of lipid level measurement in patients?]]></description>
		<pubDate>Wed, 30 May 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/must-we-fast-before-lupid-mesurements/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/must-we-fast-before-lupid-mesurements/</guid>
	</item>
	<item>
		<title>Keys to Success in Medical Coding With Medidata Coder</title>
		<description><![CDATA[Coder is a Medidata application designed for mapping verbatim terms (e.g., adverse events [AE], concomitant medications [CM], and medical history [MH]) to specific terms in industry standard dictionaries]]></description>
		<pubDate>Fri, 20 Apr 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/keys-to-success-in-medical-coding-with-medidata-coder/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/keys-to-success-in-medical-coding-with-medidata-coder/</guid>
	</item>
	<item>
		<title>SDV - What is it good for? Absolutely nothing?</title>
		<description><![CDATA[In recent years, much has been said about Source Document Verification (SDV), the comparison of information reported by an investigator to original source records to confirm its completeness, accuracy, and validity.]]></description>
		<pubDate>Mon, 26 Mar 2018 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/sdv-what-is-it-good-for-absolutely-nothing/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/sdv-what-is-it-good-for-absolutely-nothing/</guid>
	</item>
	<item>
		<title>The Best Way to Develop Regulatory Submission Documents? Survey Says...</title>
		<description><![CDATA[Recently, the Medical Writing Team at PROMETRIKA completed our second New Drug Application (NDA) submission within a year.]]></description>
		<pubDate>Wed, 28 Feb 2018 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-best-way-to-develop-regulatory-submission-documents-survey-says/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-best-way-to-develop-regulatory-submission-documents-survey-says/</guid>
	</item>
	<item>
		<title>Best Friends, Best Practices: The Synergy Between Biostatistics and Medical Writing at PROMETRIKA</title>
		<description><![CDATA[Recent articles in Medical Writing, the Journal of the European Medical Writers Association, recommend collaboration between medical writers and biostatisticians.]]></description>
		<pubDate>Wed, 31 Jan 2018 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/best-friends-best-practices-the-synergy-between-biostatistics-and-medical-writing-at-prometrika/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/best-friends-best-practices-the-synergy-between-biostatistics-and-medical-writing-at-prometrika/</guid>
	</item>
	<item>
		<title>ePRO Data and Rave: A Match Made in the [Patient] Cloud</title>
		<description><![CDATA[PROMETRIKA was the first Medidata CRO partner accredited in the Medidata Patient Cloud® platform.]]></description>
		<pubDate>Fri, 29 Dec 2017 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/epro-data-and-rave-a-match-made-in-the-patient-cloud/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/epro-data-and-rave-a-match-made-in-the-patient-cloud/</guid>
	</item>
	<item>
		<title>Global Library Data Standards: How They Benefit Cross-Functional Groups at PROMETRIKA</title>
		<description><![CDATA[As a digital repository for data collection instruments in a Clinical Data Management System (CDMS), a global library (GL) is used to streamline the database build process by increasing quality, time savings, and cost efficiencies.]]></description>
		<pubDate>Wed, 29 Nov 2017 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/global-library-data-standards-how-they-benefit-cross-functional-groups-at-prometrica/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/global-library-data-standards-how-they-benefit-cross-functional-groups-at-prometrica/</guid>
	</item>
	<item>
		<title>CDASH and SDTM: Why We Need Both!</title>
		<description><![CDATA[To streamline the exchange of clinical and nonclinical research data and ensure uniformity across studies submitted to the U.S. Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC), has developed data exchange standards to streamline clinical research and enable connections to healthcare.]]></description>
		<pubDate>Mon, 23 Oct 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/cdash-and-sdtm-why-we-need-both/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/cdash-and-sdtm-why-we-need-both/</guid>
	</item>
	<item>
		<title>The Global Library: The Benefit of Standards in a CRO-Sponsor Partnership</title>
		<description><![CDATA[The top priority of a Clinical Research Organization (CRO) is to help a sponsor conduct a successful clinical trial. That success is measured in data quality, process efficiency, and cost effectiveness.]]></description>
		<pubDate>Sat, 30 Sep 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-global-library-the-benefit-of-standards-in-a-cro-sponsor-partnership/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-global-library-the-benefit-of-standards-in-a-cro-sponsor-partnership/</guid>
	</item>
	<item>
		<title>The Interesting Life and Critical Role of a Clinical Research Associate (CRA)</title>
		<description><![CDATA[Clinical trials leverage the expertise of people in a wide variety of roles — researchers, project managers, clinical data managers, etc. One of the positions with which people may be less familiar is that of the clinical research associate (CRA).]]></description>
		<pubDate>Wed, 09 Aug 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-interesting-life-and-critical-role-of-a-clinical-research-associate-cra/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-interesting-life-and-critical-role-of-a-clinical-research-associate-cra/</guid>
	</item>
	<item>
		<title>Individual Tumor Profiling: NCI-MATCH Clinical Trial Presents New Treatment Strategy for Patients with Cancer</title>
		<description><![CDATA[This trial is particularly interesting, given the recent US Food and Drug Administration (FDA) approval of KEYTRUDA® (pembrolizumab; Merck), the first approved cancer therapy for solid tumors based on common genetic markers as opposed to initial location of the tumors.]]></description>
		<pubDate>Fri, 14 Jul 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/individual-tumor-profiling-nci-match-clinical-trial-presents-new-treatment-strategy-for-patients-with-cancer/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/individual-tumor-profiling-nci-match-clinical-trial-presents-new-treatment-strategy-for-patients-with-cancer/</guid>
	</item>
	<item>
		<title>Wearable Devices in Clinical Trials: The Current Landscape in Pharma</title>
		<description><![CDATA[Clinical research is a discipline that is constantly evolving. Currently, the most rapid innovation is occurring in the use of mobile health technology (or mHealth).]]></description>
		<pubDate>Thu, 29 Jun 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/wearable-devices-in-clinical-trials-the-current-landscape-in-pharma/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/wearable-devices-in-clinical-trials-the-current-landscape-in-pharma/</guid>
	</item>
	<item>
		<title>Ocrelizumab: The Long Road to Approval</title>
		<description><![CDATA[In “After 40-year odyssey, first drug for aggressive MS wins FDA Approval,” (Stat News, March 28, 2017), Ron Winslow describes the fascinating journey of Roche’s new multiple sclerosis (MS) drug to obtain US Food and Drug Administration (FDA) approval.]]></description>
		<pubDate>Thu, 25 May 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/ocrelizumab-the-long-road-to-approval/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/ocrelizumab-the-long-road-to-approval/</guid>
	</item>
	<item>
		<title>Targeting Toxic Proteins: Novel Drug Approaches to Defeat Dementias</title>
		<description><![CDATA[Genetic Engineering and Biotechnology News (December 16, 2016) discusses the challenges posed by the complex pathogenesis of Alzheimer’s disease (AD) and other related diseases to treatment approaches.]]></description>
		<pubDate>Thu, 27 Apr 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/targeting-toxic-proteins-novel-drug-approaches-to-defeat-dementias/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/targeting-toxic-proteins-novel-drug-approaches-to-defeat-dementias/</guid>
	</item>
	<item>
		<title>The End of Alzheimer’s disease</title>
		<description><![CDATA[This session presented an excellent opportunity to hear from panelists, Drs. Sarah Hopp (Massachusetts General Hospital), Matt Kaeberlein (University of Washington, Seattle), and Anant Paravastu (Georgia Tech), on new developments and potential therapies targeting this debilitating neurological disorder.]]></description>
		<pubDate>Thu, 20 Apr 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-end-of-alzheimers-disease/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-end-of-alzheimers-disease/</guid>
	</item>
	<item>
		<title>Observations from the MassBio 2017 Annual Meeting</title>
		<description><![CDATA[The Massachusetts Biotechnology Council (MassBio) is a not-for-profit organization focused on supporting and advancing the thriving life sciences “ecosystem” in Massachusetts.]]></description>
		<pubDate>Tue, 18 Apr 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/observations-from-the-massbio-2017-annual-meeting/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/observations-from-the-massbio-2017-annual-meeting/</guid>
	</item>
	<item>
		<title>Rare Disease Clinical Development: The Crucial Need for Patient and Parent Involvement</title>
		<description><![CDATA[February 28th, 2017 was the tenth observance of Rare Disease Day worldwide.   Rare Disease Day awareness events took place in over 80 countries through the collaboration of countless foundations and patient advocacy organizations.]]></description>
		<pubDate>Mon, 10 Apr 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/rare-disease-clinical-development-the-crucial-need-for-patient-and-parent-involvement/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/rare-disease-clinical-development-the-crucial-need-for-patient-and-parent-involvement/</guid>
	</item>
	<item>
		<title>A Case Study: Complex Oncology Study and the Boutique CRO that Provides the Perfect Model</title>
		<description><![CDATA[In assembling a team for a new trial studying a rare form of cancer, acute myeloid leukemia (AML), a prestigious cancer research center was looking for a CRO partner with unique qualities.]]></description>
		<pubDate>Fri, 07 Apr 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-case-study-complex-oncology-study-and-the-boutique-cro-that-provides-the-perfect-model/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-case-study-complex-oncology-study-and-the-boutique-cro-that-provides-the-perfect-model/</guid>
	</item>
	<item>
		<title>Gene Therapy 2.0</title>
		<description><![CDATA[MIT Technology Review (March/April 2017) lists “Gene Therapy 2.0” as one of the 10 Breakthrough Technologies of 2016.]]></description>
		<pubDate>Wed, 05 Apr 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/gene-therapy-2.0/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/gene-therapy-2.0/</guid>
	</item>
	<item>
		<title>Reflections on Rare Disease Day 2017</title>
		<description><![CDATA[On a cold, clear Tuesday morning, the State of Massachusetts commemorated the 10th anniversary of Rare Disease Day, which takes place annually all over the world on February 28th, with a celebration at the State House.]]></description>
		<pubDate>Mon, 03 Apr 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/reflections-on-rare-disease-day-2017/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/reflections-on-rare-disease-day-2017/</guid>
	</item>
	<item>
		<title>Perspectives from the Medical Writing Team</title>
		<description><![CDATA[“The Cancer Lottery” in MIT Technology Review (January/February 2017) provides an excellent overview of precision medicine in treating cancer by following the journey of an artist living with cancer for over 30 years.]]></description>
		<pubDate>Wed, 29 Mar 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/perspectives-from-the-medical-writing-team/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/perspectives-from-the-medical-writing-team/</guid>
	</item>
	<item>
		<title>Focus on Personalized Attention and Customized Reporting</title>
		<description><![CDATA[A small biopharmaceutical company with big aspirations and unlimited potential was not getting the personalized attention that they expected and deserved from their large CRO. Instead, their needs often took a backseat to the needs of larger organizations, which, in some cases, led to frustrating delays.]]></description>
		<pubDate>Mon, 27 Mar 2017 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/focus-on-personalized-attention-and-customized-reporting/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/focus-on-personalized-attention-and-customized-reporting/</guid>
	</item>
	<item>
		<title>Are Digital Health Technologies Worth It? A Frank Assessment.</title>
		<description><![CDATA[Without question digital health technologies are revolutionizing clinical development and execution. From electronic patient reported outcome (ePRO) systems to wearable devices, they can, when used properly, provide many benefits.]]></description>
		<pubDate>Tue, 25 Oct 2016 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/are-digital-health-technologies-worth-it-a-frank-assessment/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/are-digital-health-technologies-worth-it-a-frank-assessment/</guid>
	</item>
	<item>
		<title>The Continuing Evolution of the Clinical Data Manager Role</title>
		<description><![CDATA[Last year in our blog post titled “The New Clinical Data Manager,” we wrote about some key changes to the clinical data manager role that have taken place in recent years.  What is fascinating to me is the pace at which the versatile position continues to evolve.  ]]></description>
		<pubDate>Fri, 22 Jul 2016 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-continuing-evolution-of-the-clinical-data-manager-role/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-continuing-evolution-of-the-clinical-data-manager-role/</guid>
	</item>
	<item>
		<title>The Clinical Study Report – Changing at Its CORE?</title>
		<description><![CDATA[All the activity of a clinical study culminates in the production of a clinical study report (CSR). More than a written summary of the results of a study, among its contents are the protocol followed during study conduct, lists of investigators, and the statistical output and methods. If printed, a CSR could number 1000 pages or more.]]></description>
		<pubDate>Fri, 18 Dec 2015 00:00:00 -0500</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-clinical-study-report-changing-at-its-core/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-clinical-study-report-changing-at-its-core/</guid>
	</item>
	<item>
		<title>The New Clinical Data Manager</title>
		<description><![CDATA[The role and skill set of a Clinical Data Manager (CDM) is constantly changing as technology and processes advance. CDMs have evolved into data management leaders, possessing skills in areas such as database building and programming, project management, and budget maintenance, on top of the standard collection, cleaning, and management of subject data in compliance with regulatory standards.]]></description>
		<pubDate>Wed, 16 Sep 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/the-new-clinical-data-manager/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/the-new-clinical-data-manager/</guid>
	</item>
	<item>
		<title>Risk-Based Monitoring</title>
		<description><![CDATA[Risk-based monitoring in clinical trials involves targeted monitoring that may include 100% source data verification for specified critical data points and partial source data verification of other data.]]></description>
		<pubDate>Wed, 19 Aug 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/19-2015-risk-based-monitoring/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/19-2015-risk-based-monitoring/</guid>
	</item>
	<item>
		<title>Ensuring the IDMC is Independent: The Case for Outsourcing IDMC Statistical and Coordination Services</title>
		<description><![CDATA[The number of clinical trials incorporating independent data monitoring committees (IDMCs) for safety and efficacy monitoring is on the rise. Currently, it is recommended that late-stage trials with a major morbidity or mortality endpoint, or studies in vulnerable patient populations with a large enrollment, use an IDMC to review the interim safety and efficacy data.]]></description>
		<pubDate>Tue, 14 Jul 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/ensuring-the-idmc-is-independent-the-case-for-outsourcing-idmc-statistical-and-coordination-services/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/ensuring-the-idmc-is-independent-the-case-for-outsourcing-idmc-statistical-and-coordination-services/</guid>
	</item>
	<item>
		<title>A New Certification to Come to Clinical Research</title>
		<description><![CDATA[Certification is recognized throughout the clinical research field as a sign of professional competency and knowledge of clinical development in the pharmaceutical industry]]></description>
		<pubDate>Wed, 03 Jun 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/a-new-certification-to-come-to-clinical-research/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/a-new-certification-to-come-to-clinical-research/</guid>
	</item>
	<item>
		<title>Keys to Effective Clinical Trial Site Management</title>
		<description><![CDATA[Proper site management by the Sponsor and/or CRO is an essential element of clinical trial execution and in ensuring trial success. An appropriate level of site management and oversight empowers sites to effectively recruit, treat, and retain subjects while ensuring regulatory compliance, protocol adherence, the protection of subjects’ rights, subject safety, and overall management of screened and enrolled subjects.]]></description>
		<pubDate>Thu, 14 May 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/keys-to-effective-clinical-trial-site-management/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/keys-to-effective-clinical-trial-site-management/</guid>
	</item>
	<item>
		<title>PROMETRIKA Guides Mindful Implementation of ePRO Solutions</title>
		<description><![CDATA[Today’s clinical development is more patient-centric – focusing not only on treating the patient’s disease or dysfunction but also on the patient’s experience of, and desired outcomes for, treatment.]]></description>
		<pubDate>Fri, 24 Apr 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/prometrika-guides-mindful-implementation-of-epro-solutions/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/prometrika-guides-mindful-implementation-of-epro-solutions/</guid>
	</item>
	<item>
		<title>PROMETRIKA Supports Advanced Research in MS</title>
		<description><![CDATA[Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS). It is hypothesized that CNS auto-reactive T cells are stimulated in the peripheral circulation to become active and proliferate, with subsequent migration into the CNS compartment.]]></description>
		<pubDate>Fri, 17 Apr 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/17-2015-prometrika-supports-advanced-research-in-ms/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/17-2015-prometrika-supports-advanced-research-in-ms/</guid>
	</item>
	<item>
		<title>PROs: Ground to Cloud in 10 Years</title>
		<description><![CDATA[Patient-reported outcome (PRO) instruments, such as patient-completed (or interviewer-administered) diaries, questionnaires, and visual analog scales (VAS), have been a part of clinical research for many years.]]></description>
		<pubDate>Wed, 11 Mar 2015 00:00:00 -0400</pubDate>
		<link>https://www.prometrika.com/thought-leadership/thought-leadership/pros-ground-to-cloud-in-10-years/</link>
		<guid>https://www.prometrika.com/thought-leadership/thought-leadership/pros-ground-to-cloud-in-10-years/</guid>
	</item>
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