PROMETRIKA, LLC

A Full-Service Clinical Research Organization

Oct 23 2017

CDASH and SDTM: Why We Need Both!

The Data Standards Series: Part 2

Amarachi Umez-Eronini, MPH, Biostatistician I / Statistical Programmer III, PROMETRIKA, LLC

Data Standards Developed by the Clinical Data Interchange Consortium

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.  As stated on the CDISC website introduction, “Unlocking cures is our life’s work.  At CDISC, we enable clinical research to work smarter by allowing data to speak the same language.”

Within the CDISC organization, there are several data exchange standards. The most commonly used exchange standards at PROMETRIKA include: Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM).  These standards allow sponsors to submit study data in electronic format to the FDA or other regulatory agencies.  As of December 17, 2016, with the exception of CDASH (though strongly recommended), the following data formats, supported by the FDA and listed in the FDA’s Data Standards Catalog, are required when submitting study data. Continue reading “CDASH and SDTM: Why We Need Both!”

Sep 30 2017

The Global Library: The Benefit of Standards in a CRO-Sponsor Partnership

The Data Standards Series: Part 1

Jennifer Yee, Clinical Data Manager III, PROMETRIKA, LLC

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. In order to achieve these goals, many organizations find they benefit from the development of a global library. A global library (GL) is a digital repository in a Clinical Data Management System (CDMS) that contains data collection instruments, such as electronic case report forms (eCRF) and their associated programming elements.

During database build, the library functionality allows for the copying of pre-validated objects, such as variables, code lists and edit checks, from the GL into new projects. Confidence in the pre-validation of the GL allows these objects to be copied without reprogramming or testing. By eliminating these time-consuming tasks, CROs can develop projects with design consistency, significant time savings, and reduced cost; features critical to the success of a study.

Continue reading “The Global Library: The Benefit of Standards in a CRO-Sponsor Partnership”

Aug 09 2017

The Interesting Life and Critical Role of a Clinical Research Associate (CRA)

Stephen Cropper, Senior Clinical Research Associate, Clinical Operations, PROMETRIKA, LLC

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). CRAs play a critical, if somewhat unheralded, role in the success of a trial. Continue reading “The Interesting Life and Critical Role of a Clinical Research Associate (CRA)”

Jul 14 2017

Individual Tumor Profiling: NCI-MATCH Clinical Trial Presents New Treatment Strategy for Patients with Cancer

Perspectives from the Medical Writing Team

Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

“Individual Tumor Profiling:  Has Tumor Molecular Profiling Enabled More Effective and Less Toxic Cancer Treatment?” provides an overview of the use of tumor profiling in the nationwide National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH) clinical trial for treatment of cancer.  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.   Continue reading “Individual Tumor Profiling: NCI-MATCH Clinical Trial Presents New Treatment Strategy for Patients with Cancer”

Jun 29 2017

Wearable Devices in Clinical Trials: The Current Landscape in Pharma

Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC

What is mHealth Technology and what are Wearable Devices?

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). In particular, wearable devices (also called wearable gadgets or simply wearables) for data-gathering are becoming a major focus for many pharmaceutical companies.

The integration of wearables with smartphones has made the collection of a continuous stream of real-time data less disruptive for participants. This emerging digital research platform holds the potential for increasing the accuracy and timeliness of data, improving clinical efficiencies, and promoting greater patient engagement in the clinical trial process. Continue reading “Wearable Devices in Clinical Trials: The Current Landscape in Pharma”

May 25 2017

Ocrelizumab: The Long Road to Approval

Perspectives from the Medical Writing Team

Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

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.  This drug, ocrelizumab, offers new hope to the 10% to 15% of MS patients who have primary-progressive disease (PPMS).  The approval of ocrelizumab not only provides a promising therapeutic option to patients with MS, but also represents a textbook example of the importance of innovative thinking and perseverance in scientific research; the latter being one of the main reasons I elected to write about this article.

Continue reading “Ocrelizumab: The Long Road to Approval”

Apr 27 2017

Targeting Toxic Proteins: Novel Drug Approaches to Defeat Dementias

 Perspectives from the Medical Writing Team

Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

Targeting Toxic Proteins:  Novel Drug Approaches to Defeat Dementias” in 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.  Because of my research background in protein folding and degradation, I am particularly interested in disorders, such as AD, that stem from misfolding and/or aggregation of proteins.

Despite many years of research, treatment options for AD remain limited.  Lack of efficacy have resulted in termination of a large number of clinical trials for AD, as exemplified by the recent failure of Eli Lilly’s solanezumab in a Phase 3 trial.  While most therapeutic approaches so far have been targeting one type of protein, it may be worthwhile to consider a different strategy that aims at a broader set of targets. Continue reading “Targeting Toxic Proteins: Novel Drug Approaches to Defeat Dementias”

Apr 20 2017

The End of Alzheimer’s disease

Perspectives from the Medical Writing Team

Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

I recently attended the MIT Alumni Association webcast of an online faculty forum titled “The End of Alzheimer’s disease.”  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.  It was also very informative listening to audience questions and obtaining a better understanding of people’s concerns and thoughts on this disease. Continue reading “The End of Alzheimer’s disease”

Apr 18 2017

Observations from the MassBio 2017 Annual Meeting

Stephen Cropper, Senior Clinical Research Associate, Clinical Operations, PROMETRIKA, LLC

The Massachusetts Biotechnology Council (MassBio) is a not-for-profit organization focused on supporting and advancing the thriving life sciences “ecosystem” in Massachusetts. Founded in 1985, it represents nearly 1,000 biotechnology companies, academic institutions, disease foundations, and other organizations.

On March 30 – 31, 2017, MassBio held its Annual Meeting in Cambridge, MA. Along with Miganush Stepanians, Ph.D., the President and CEO of PROMETRIKA and LuAnn Sabounjian, PROMETRIKA’s Head of Clinical Operations & Drug Safety, I attended the event and would like to recap the highlights of the two days. Continue reading “Observations from the MassBio 2017 Annual Meeting”

Apr 10 2017

Rare Disease Clinical Development: The Crucial Need for Patient and Parent Involvement

LuAnn Sabounjian, Head of Clinical Operations & Drug Safety, PROMETRIKA, LLC

Rare Disease Clinical Trials

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. This year’s theme was research that inspires and empowers the rare disease community, as captured in the slogan, “With research, possibilities are limitless.”

While there is no universal definition for the term “rare disease”, in the United States, a condition is considered “rare” if it affects fewer than 200,000 persons combined in a particular rare disease group. There are approximately 7,000 different types of rare diseases and disorders, with more being discovered each day. Over 30 million people in the United States are living with rare diseases – 50% of whom are children. Continue reading “Rare Disease Clinical Development: The Crucial Need for Patient and Parent Involvement”

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