PROMETRIKA Celebrates Fifteen Years of Excellence
Miganush Stepanians, Ph.D.
President & CEO, PROMETRIKA, LLC
A Message from Our Founder
This year marks PROMETRIKA's fifteenth anniversary. For the past 15 years, we have had the great honor and privilege of collaborating with dedicated, compassionate, and innovative teams of clinical trial professionals who work each day to improve the lives of patients throughout the world.
Today, we are a full service team of 85 clinical trial professionals with an exemplary track record that includes significant contributions for nearly 1,000 clinical trials and 12 NDA submissions and a client roster of 100 companies. We are so grateful to our clients for putting their faith in us, and we look forward to many more years of providing best in class innovative clinical research services to our sponsor companies.
Small and Smart, and Other Industry Intrigues of 2017
M. Alexandra Rohall, Sr. Manager, Medical Writing, PROMETRIKA, LLC
A single review of the past year within the biopharmaceutical industry cannot comprehensively cover all developments. In 2017, FDA issued 226 draft and final guidance documents addressing its current thinking with regard to food, laboratory, blood banking, drug, and device regulations. With respect to the research of drugs and biologics, some of these guidances covered topics in drug and biologic technology, product classification (drug, device, or combination), pediatric rare and serious diseases, and software as a medical device (SaMD). In the following segments, a few of these topics are addressed, particularly as they pertain to areas of heightened activity in the industry. Under new FDA leadership, the industry looks forward to further support of innovation in clinical research.
For the past 25 years, the US Congress has sought to incentivize the biopharmaceutical industry to undertake the complex and expensive task of research and development of treatments for small markets. The Orphan Drug Act (ODA)1 of 1983 identified rare diseases and conditions as those with a prevalence of < 200,000 patients in the US, or with a prevalence of ≥ 200,000 but for which the cost of drug development could not reasonably be expected to be recovered by US sales. Incentives included tax credits to defray research costs, seven years of market exclusivity, and waiver of the marketing application user fee. Since 1983, annual orphan drug approvals have increased more than 10-fold.2
Over the ensuing years, there has been greater recognition of the need to develop treatments particularly for children with rare diseases. The 1997 FDA Modernization Act3 gave sponsors another six months of market exclusivity when pediatric studies were included in a submission. And the Pediatric Research Equity Act (PREA)4 of 2003 required that certain applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration include safety and effectiveness data for the proposed indication in relevant pediatric populations.
This year, FDA has taken two steps to advance the development of treatments for rare pediatric disorders. The FDA Reauthorization Act (2017) extended the scope of PREA to require pediatric studies of certain adult oncology drugs aimed at a molecular target substantially relevant to the growth or progression of pediatric cancer. In addition, the Draft Guidance for Industry: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases (December 2017)5 indicates that FDA will no longer grant orphan drug designation to drugs for pediatric subpopulations of non-rare diseases, unless the pediatric subpopulation meets other regulatory criteria for orphan status or the disease in the pediatric subpopulation is considered a different disease than that in the adult population. This clarification closes a loophole by which sponsors could obtain pediatric-subpopulation orphan status, which carries no obligation to do pediatric trials, and thereby avoid PREA requirements. With these two actions, FDA aims to increase drug development for pediatric rare and serious diseases.
Also released at the end of 2017, FDA's Draft Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials (December 2017)6 represents FDA's commitment to addressing new technological developments that will lead to precision treatments and, thereby, benefit patients. The guidance outlines FDA's approach to examining products containing nanomaterials by providing working definitions of these materials, and by indicating the research, at each phase of development, that sponsors may need to perform to have their new nanomaterial products considered for approval.
From the standpoint of clinical development, this guidance pertains to nanomaterial products developed using comparisons to a reference product; i.e., along the 505(b)(2), 505(j), or 351(k) pathways. Using definitions and examples, the guidance categorizes nanomaterials along the lines of their low, medium, or high risk for exhibiting clinically significant changes in exposure, safety, and/or effectiveness relative to the reference product. Especially with regard to new products considered to have a medium or high risk of clinically significant differences, FDA indicates that studies beyond the standard bioequivalence study, i.e., beyond comparative plasma PK, may be needed to provide the necessary bridging data. Nanomaterials, which can act as therapeutics, carriers of therapeutics, or inactive ingredients, can alter delivery targets, delivered doses, and clearance pathways of drug products, to name a few effects. Therefore, careful elucidation of the similarities and differences between the new and reference products is necessary when pursuing approval along reference product pathways. FDA hopes that providing this guidance will help sponsors prepare efficient clinical development plans for products containing nanomaterials.
Advances in data science over the past decade have increased the focus on data collection in clinical trials. Developments in clinical data management are rising to the challenges. One such challenge is the desire of independent endpoint adjudicators to have access to nearly real-time data, whether or not blinded. For trials involving multiple sites that may have differing standards of care, or medical or cultural biases, endpoint adjudication is aimed at standardizing endpoint data interpretation, and allows sponsors to correct data interpretation and quality issues while a trial is in progress. To this end, having trial data on integrated platforms is one focus of clinical database software providers.
Clinical and laboratory data have been integrated in electronic data capture (EDC) systems for a number of years. In the past year or two, several vendors of these sophisticated clinical databases have been introducing add-on modules for randomization, drug supply management, mobile device data collection, and clinical trial management functions. These utilities, residing on a single platform, allow data visualization and data mining that can enhance a sponsor's ability to optimize trial efficiency and data quality.
There is rapidly growing interest in mobile device and wearable device data collection, known as mHealth or digital health. There are hopes that mHealth data can be collected through web applications directly linked to clinical databases. But questions remain about the security and integrity of these data.
One aspect of digital health technology is SaMD. Since 2013, the International Medical Device Regulators Forum (IMDRF) has been developing a framework for SaMD and converged principles for global regulators to adopt in their respective jurisdictions. The Working Group's most recent document, Software as a Medical Device: Clinical Evaluation, released in June of 2017, has been issued as a Guidance for Industry and FDA Staff (December 2017).7 FDA prefaces the guidance by noting that the IMDRF document provides FDA with an initial framework on which to develop FDA's specific regulatory approaches and expectations for regulatory oversight of SaMD.
SaMD: Clinical Evaluation builds on the three previous reports that covered definitions, risk categorization, and quality management systems for SaMD. The clinical evaluation of SaMD should be an iterative and continuous process that answers the questions of a valid clinical association between the SaMD output and the target condition; the correct processing of input data to generate accurate, reliable, and precise output data; and whether the output data achieves the intended purpose with regard to clinical care in the target population. As mHealth grows in popularity with the medical profession, payers, and consumers, technical and clinical evaluation of SaMD will be incorporated into the clinical research process by FDA and agencies around the world.
In recent years, there has been much discussion of innovative ways to control the cost of clinical development. One of the most costly areas within the industry is clinical operations, the function that handles the logistics, conduct, and data collection of a trial. As traditionally conducted, clinical monitoring is one of the most costly functions within clinical operations. The industry has been examining the elimination of 100% source document verification (SDV) of trail data and a move to risk-based monitoring (RBM), which includes off-site monitoring methods.
In June 2017, the European Medicines Agency became the first regulatory authority to put into effect the ICH E6 addendum (R2). In recognition of the spiraling costs associated with traditional on-site monitoring, including 100% SDV, ICH expanded the acceptable methods for trial monitoring. Sponsors are encouraged to assess trial risks and develop appropriate monitoring strategies during the protocol development phase. Through recent technological advances, such as wearable devices and EDC, sponsors can get a real-time view of data, thereby increasing surveillance of subject safety and of data integrity. These technologies lend themselves to central trial monitoring, which leads to more efficient data cleaning and reduced onsite monitoring costs. Central monitors have a broader view of the data across all subjects and can address data integrity issues more swiftly than is common in traditional monitoring models.
The flexibility of the monitoring model allowed by E6 (R2) lends itself particularly well to the study of rare diseases. The small numbers of subjects, and commensurate limited quantity of data, requires closer, more frequent examination to ensure data integrity and patient safety. Central monitoring and real-time data collection can allow sponsors to monitor and identify risks much more quickly than onsite monitoring alone. This allows for faster mitigation actions that improve data integrity and ensure subject safety.
Five years ago, a consortium of data scientists took up the challenge of developing the technology to facilitate a learning healthcare system (LHS) using the data collected in electronic health records (EHRs) in European countries. The aim of the project, known as TRANSFoRm,8 was to develop a "rapid LHS," driven by advanced computational infrastructure, that could improve patient safety, and the conduct and volume of clinical research in Europe. The hope was that this standardized, minable database would speed differential diagnosis for patients and would provide clinical researchers, through standard electronic case report forms within EHRs, with rapid access to eligibility information, data points, timelines, and interventions in trial subjects.
A few of the many challenges included: management of privacy laws; terminology mapping in light of semantic variations across countries and languages; assessing data quality; creating clinical prediction rules based on ontological representation of clinical cues and differential diagnoses; and developing software and testing models to ensure that data were of sufficient quality to be used in research.
The scientists used Clinical Data Interchange Standards Consortium (CDISC) standards in the development of the many necessary platforms and services. Their achievements in meeting the challenges led to the successful development, validation, and evaluation of the first real-world clinical trial using primary care EHRs. In this trial, patient reported outcome measures (PROMs), captured on a mobile device, were analyzed for 600 subjects in four countries, with four different languages, and using four different EHR systems. The successes of the TRANSFoRm project and the first trial of TRANSFoRm's technologies open the door to enhanced and timely international clinical trials.
In the current environment of rapid technological advancement, drug product development often includes emerging technologies not yet familiar to FDA scientists. In September 2017, the Center for Drug Evaluation and Research (CDER) finalized its Guidance for Industry: Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization.9 In this guidance, FDA encourages sponsors whose drug production includes emerging technology to ask for guidance from FDA's Emerging Technology Team (ETT), a group of scientists representing each FDA pharmaceutical quality function. The ETT answers the sponsor's questions about the types of information FDA expects to see in an upcoming submission (e.g., IND, NDA), evaluates the technology with regard to legal and regulatory standards, guidances, and policy, and provides leadership during FDA's assessment of the Chemistry, Manufacturing, and Controls (CMC) section of a submission.
Through this Emerging Technology Program, which allows early engagement and meeting opportunities for sponsors planning to use novel technologies, FDA intends to encourage innovative approaches to pharmaceutical manufacturing, which will ultimately improve product quality and availability.
PROMETRIKA is excited to be part of the evolving clinical research landscape. Thanks to the many biopharmaceutical industry sponsors who put their trust in our expertise, PROMETRIKA has been involved in many of the year's most interesting trials and technological advances. We look forward to participating in the operational and scientific advances to come in 2018.
PROMETRIKA to Present Three Sessions at 2017 Medidata NEXT Global in New York
Experts from the Cambridge, MA CRO will gather with industry leaders to discuss the impact of technology on clinical research.
CAMBRIDGE, MA, November 6, 2017 - PROMETRIKA, LLC (www.prometrika.com), a full-service Clinical Research Organization, has announced it will take an active role at Medidata NEXT Global 2017 in New York, November 8-10. This event offers keynote speakers, breakout sessions, and interactive learning opportunities for industry leaders around the globe. Medidata NEXT Global is the centerpiece of the largest annual event series of its kind, attracting over 3,000 attendees across events in Basel, Berlin, London, New York, Seoul, Shanghai and Tokyo.
“I am pleased that three of PROMETRIKA’s team members were selected by Medidata to share their experiences with Medidata’s suite of trial enhancement products,” said Miganush Stepanians, PhD, President and CEO of PROMETRIKA. “PROMETRIKA is a Medidata Rave® Partner and has always been an early adopter of Medidata’s solutions. We are eager to engage in compelling discussions of best practices in technology solutions with our colleagues in the industry.”
PROMETRIKA team members will present in three sessions:
Study Conduct I: Study Conduct Medical Coding (Keys to Success in Medical Coding From A to Z) Cathy Hult, Senior Manager, Data Management. Thursday, November 9.
Cathy will speak about PROMETRIKA’s recent experience implementing Medidata Coder® after many years of using an external, standalone, coding tool. Medidata Coder is integrated with Rave EDC, offering real time coding of verbatim terms and enhancing coding consistency review process.
Download Presentation PDF
View Presentation Video
Patient Engagement: ePRO Data Integration with Rave: Case Studies With and Without Patient Cloud. Kathy Zheng, MPH, Senior Project Manager. Friday, November 10.
In this presentation, Kathy will describe PROMETRIKA’s most recent experiences with ePRO solutions, demonstrating the differences between integrating an external ePRO solution with Medidata Rave, versus implementing a solution within the Medidata suite of products.
Download Presentation PDF
View Presentation Video
Support Site: SDV…What is it Good For? Absolutely Nothing? Stephen Cropper, Senior Clinical Research Associate, Clinical Operations. Friday, November 10.
In his presentation, Stephen will address technological improvements in the field of clinical trial monitoring that have improved data review. He also will discuss data management tools intended to produce smart, accurate, and efficient data results.
Download Presentation PDF
“PROMETRIKA has been a strong partner with Medidata for several years,” said Simon Mouyal, Chief Marketing Officer of Medidata. “We were delighted to include three of their presentations for this year’s event. We’re excited for them to share their insight and achievements in clinical trial innovation.”
About PROMETRIKA, LLC - www.prometrika.com
Founded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique Clinical Research Organization, utilizing a collaborative approach to clinical development and execution with a close-knit, highly-experienced senior leadership team that remains involved throughout the duration of each trial. PROMETRIKA’s services include complete clinical operations and clinical trial management, data management, pharmacovigilance, biostatistics and programming, medical writing, and regulatory submissions.
Medidata is reinventing global drug and medical device development by creating the industry's leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including over 950 global pharmaceutical companies, innovative biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.
The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers— from study design and planning through execution, management and reporting.
PROMETRIKA to coordinate second Phase I trial for MD Anderson’s Institute for Applied Cancer Science
Cambridge, MA-based clinical research organization to manage Phase 1 advanced solid tumors and lymphoma study.
CAMBRIDGE, MA, October 16, 2017 - PROMETRIKA, LLC, a boutique full service Clinical Research Organization (CRO), is coordinating a Phase 1 trial for The University of Texas MD Anderson Cancer Center’s Institute for Applied Cancer Science. PROMETRIKA is responsible for the clinical trial management and site monitoring, medical monitoring, database implementation and data management, pharmacovigilance, biostatistics, and medical writing for this advanced solid tumors and lymphoma trial.
“We are excited to work on a second Phase I trial with the institution as it works to end cancer,” said Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA.
This study presents another opportunity for PROMETRIKA to leverage its considerable expertise and experience in Phase 1 oncology trials and to contribute to the ongoing fight against cancer.
PROMETRIKA Announces New Associate Director of Statistical Programming
Susan Boquist has joined PROMETRIKA’s Statistical Programming Team as Associate Director.
CAMBRIDGE, MA, October 6, 2017 - PROMETRIKA, LLC has announced that Susan Boquist has joined their Statistical Programming team as Associate Director. Ms. Boquist brings to this position over 20 years of diverse experience including leadership roles in statistical programming, data standards implementation, and clinical database design.
At PROMETRIKA, Susan will direct statistical programmers in the design, implementation, and quality review of programming to support statistical analyses of trial data. Susan will contribute her expertise in CDISC SDTM and CDISC ADaM standards to further enhance PROMETRIKA’s delivery of best-in-class clinical research.
“Susan’s experience and leadership skills are a significant addition to our company,” commented Miganush Stepanians, President & CEO. “As a leader in statistical programming, she has excelled at developing highly-skilled programming teams exhibiting the flexibility necessary in today’s biotechnology and pharmaceutical development space. Susan’s deep and wide knowledge as a SDTM subject matter expert will further enhance PROMETRIKA’s leadership in the area of data standardization and electronic data submissions to regulatory authorities.”
Ms. Boquist’s prior leadership roles have included Senior Manager of Statistical Programming and Associate Manager of Clinical Database Programming at PAREXEL International Corp. Her work has covered studies in a variety of therapeutic areas including oncology, infectious disease, anesthesiology, and allergy/immunology. She has also been a team member on several successful FDA and PMDA new drug submissions.
“I am excited to join this growing and innovative full-service CRO,” said Ms. Boquist. “This is a tremendous opportunity for me to bring both my professional experience in CDISC implementation and my leadership experience developing teams with a constant eye on collaboration, process improvement, and training.”
Ms. Boquist received her Bachelor of Arts (Psychobiology) degree from Mount Holyoke College.
PROMETRIKA Announces New Leadership Team Member
Heather Paden, MS, has joined PROMETRIKA's Leadership Team as Head of Clinical Operations.
CAMBRIDGE, MA, August 30, 2017 - PROMETRIKA, LLC has announced that Heather Paden, MS, has joined their Leadership Team as Head of Clinical Operations. Ms. Paden brings to this position over 20 years of diverse experience in clinical research, including operational and scientific leadership roles, clinical trial management and monitoring, publication planning, product lifecycle management, and clinical training and education.
At PROMETRIKA, Heather will lead Clinical Operations in day-to-day trial management activities and in the development of systems and procedures to further enhance PROMETRIKA's delivery of best-in-class clinical research.
"Heather's experience and approach is a natural fit for our company," commented Miganush Stepanians, President & CEO. "As a leader in clinical research and operations, she has always excelled at translating business and scientific objectives into pragmatic working plans throughout the execution of clinical studies, ensuring high levels of quality and efficiency. This approach is one of the many reasons I am excited to have her join our leadership team."
Ms. Paden's leadership roles have included Head of Clinical Development Operations at ContraFect Corp., Senior Consultant at Halloran Consulting, and Director of Clinical Development Medical Affairs at Boehringer Ingelheim Pharmaceuticals. Her work has covered orphan indications in oncology, cardiovascular disease, and genetic disorders.
"I am eager to bring my years of experience in cross-disciplinary management of large and small trials to this growing full-service CRO", said Ms. Paden. "I am equally as enthusiastic to be part of an organization that sees the value in a collaborative team approach to clinical trials, and look forward to working with the entire team."
Heather received her Masters of Science in Respiratory Care, Clinical Trial Design, and Project Management from Northeastern University, and her Bachelor of Science (Respiratory Care) and Bachelor of Arts (Human Biology) degrees from the University of Kansas.
PROMETRIKA increases efficiency and improves data quality through implementation of Medidata Coder® and integration with Medidata Rave® EDC system
Ability to streamline workflows and automatically double-check coding allows clinical research organization to boost productivity while ensuring consistently high standards
CAMBRIDGE, MA, July 26, 2017 - PROMETRIKA, a full service clinical research organization, has announced the successful implementation of the Medidata Coder product and integration with the Medidata Rave electronic data capture (EDC) system. Accredited in the Rave Coder Platform in March 2017, PROMETRIKA is now capitalizing on the synergy between the two systems, to the benefit of study sponsors.
Medidata Coder is an application that maps verbatim terms such as "adverse events" or "concomitant medications" to specific codes in industry-standard dictionaries like MedDRA and WhoDrug. Integration with Medidata Rave allows terms entered into the database to be processed through Medidata Coder and automatically placed in the Rave database.
"Implementing Medidata Coder is an example of how we are always looking for ways to better serve study sponsors, both in terms of productivity and data quality," said Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA. "While we've been using Medidata Coder, we have seen a number of benefits from its ability to accurately assign codes to verbatim terms in real time."
Among the advantages PROMETRIKA and its clients are enjoying from the new integration are:
- Customizable Configurations: The ability to configure the system to meet study-specific workflows and approval processes
- Review Process Enhancements: Capabilities like manual coding or real-time auto-coding, the creation of synonyms and synonym lists, direct querying of study sites to clarify verbatim terms, reclassification of terms, code consistency review, and generation of coding consistency listings that make information available for Safety Review and Data Monitoring Committee meetings
- Quality Control Measures: Coding consistency review that can be performed continuously, allowing for faster feedback on coding assignments and serving as an extra level of quality control in addition to that provided by the Clinical Data Manager (CDM)
PROMETRIKA to present poster on Angelman Syndrome Natural History Study results at Annual American Academy of Neurology Meeting
Cambridge-based clinical research organization and Boston Children's Hospital collaborating on research into rare genetic disorder
CAMBRIDGE, MA, April 24, 2017 - PROMETRIKA, a boutique, full-service clinical research organization, will present initial findings from a Natural History Study of Angelman Syndrome at the American Academy of Neurology (AAN) Annual Meeting in Boston. The event, which is the largest gathering of neurologists in the U.S., will take place April 22-28. The poster presentation is based on research performed in collaboration with Boston Children's Hospital and will be the first time a longitudinal analysis of this rich data set has been shared.
"We're honored to have the opportunity to share results from our collaboration with Boston Children's Hospital at this prestigious event,' said Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA, who will be presenting along with Nicole LaVallee, Ph.D., the company's Director of Biostatistics. "Angelman Syndrome is a relatively unknown rare disorder with tragic life-long consequences for patients and their families. We are so pleased to be in a position to be able to assist with work that will help raise awareness about the condition and the role that molecular subtypes play in its expression," she added.
Angelman Syndrome (AS) is a rare neuro-genetic disorder that occurs in one in 15,000 live births. It may be misdiagnosed as cerebral palsy or autism due to lack of awareness of the condition. AS is characterized by symptoms that include developmental delays that begin between 6 and 12 months of age, lack of speech, seizures that often begin between 2 and 3 years of age, and walking and balance disorders. People with AS tend to have happy personalities and are known to smile and laugh frequently. They have normal life expectancies, but the disease cannot be cured and individuals with AS require lifelong care.
The purpose of the analyses being performed by PROMETRIKA and Boston Children's Hospital is to examine patterns of maladaptive behaviors in individuals with AS over time and to assess the relationship of maladaptive behaviors to molecular subtype and current level of developmental functioning. The poster, titled Maladaptive Behaviors in Individuals with Angelman Syndrome, will be presented on April 28th, 2017.
PROMETRIKA to coordinate Phase I trial for MD Anderson's Institute for Applied Cancer Science
Cambridge, MA-based clinical research organization to manage Phase 1 acute myeloid leukemia study
CAMBRIDGE, MA, March 20, 2017 - PROMETRIKA, a boutique full service clinical research organization, is coordinating a Phase 1 trial for The University of Texas MD Anderson Cancer Center's Institute for Applied Cancer Science. PROMETRIKA is responsible for the clinical trial management and site monitoring, medical monitoring, database implementation and data management, study drug management, pharmacovigilance, biostatistics, and medical writing. This trial is in acute myeloid leukemia (AML), which is a rare form of cancer with approximately 10,500 new cases each year in the United States.
"We are thrilled to work on this important trial alongside the institution in its pursuit to end cancer", said Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA.
As a CRO focused on both rare diseases and oncology, this study presents another opportunity for PROMETRIKA to leverage its considerable expertise and experience in AML in the ongoing fight against this devastating disease.
PROMETRIKA Growth Across All Areas Leads to Office Move
PROMETRIKA moves to a new office in Cambridge, MA with 60% more space.
CAMBRIDGE, MA, October 14, 2016 -- - PROMETRIKA (www.prometrika.com), a full-service Clinical Research Organization (CRO), has moved to a larger space in Cambridge, MA. The move is driven by PROMETRIKA's recent growth that has been in response to an increase in demand from their pharmaceutical, biotechnology and medical device clients for full-service clinical research offerings.
"PROMETRIKA has experienced tremendous growth over the past several years, thanks in large part to the faith our clients have had in our work. In the past two years, we have added 25 new members to our PROMETRIKA team," said Vahe Zeroonian, Principal & CFO of PROMETRIKA. "We have had remarkable expansion among our clinical operations team and services, and we have continued to grow our strong biostatistics and data management staff at the same time. This growth has required us to move to a space that will accommodate our continuously-expanding team."
PROMETRIKA has moved its offices to a new location at 100 CambridgePark Drive in Cambridge, Massachusetts, giving them 60% more office space. The office is located across from the Alewife T station, just four stops from Kendall Square.
"It has been a remarkable journey since I started PROMETRIKA in 2003, and the last few years have been particularly exciting," stated Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA. "Today our partnerships with our clients are often broader, more strategic, comprehensive and long-term, covering the span of product development from phase 1 through regulatory submissions. It is this shift in how we are partnering with our clients that is driving our growth; we need to ensure we have the capacity and space to continue to collaborate as a team and exceed our clients' expectations.
PROMETRIKA's President and CEO, Miganush Stepanians, PhD will moderate July Edition of MassBio's Digital Healthcare Series
"Mobilizing" Clinical Trials: New Technologies for Accuracy, Efficiency and Real-Time Data Capture
When: July 21st, 8AM–10AM
Where: MassBio Offices: 300 Technology Square, 8th Floor, Cambridge, MA 02139
CAMBRIDGE, MA, July 18, 2016 -- This week, the second Forum of a three-part series on the challenges and opportunities of digital healthcare will take place at MassBio's headquarters in Cambridge, MA. This event will feature a panel of industry leaders, and will be moderated by PROMETRIKA's own Miganush Stepanians, Ph.D., President and CEO.
We are excited to be part of this great discussion on uncovering what digital healthcare means for life sciences industry professionals and how it affects patients. This forum will highlight how digital health technologies -- such as wearable devices, mobile applications, sensors and more -- have the potential to revolutionize clinical trials and natural history studies.
We hope you will join us to learn how these technologies can support real-time trial oversight and accurate, efficient and timely data capture from the following panelists:
- David Alexanderian, DO, Medical Director, Global Clinical Development Lead, Shire Pharmaceuticals
- Amit Rakhit, MD, MBA, Chief Medical and Portfolio Management Officer, Ovid Therapeutics
- Ahmet Uluer, DO, Director, Adult Cystic Fibrosis Program, Boston Children's Hospital; Director,
Weitzman Family Bridges Adult Transition Program; Assistant Professor of Pediatrics, Harvard Medical School
- Kathy Zheng, MPH, Sr. Project Manager, PROMETRIKA, LLC
To register for this event or find more information, please click the link below. This event is free for members, and open to nonmembers for a $35 fee. Members also have the option to live-stream this forum if they are unable to attend in person.
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PROMETRIKA Delivering Two Presentations at the Upcoming 2015 Medidata Symposium
CAMBRIDGE, MA, September 28, 2015 -- PROMETRIKA, LLC, a full-service clinical research organization (CRO),
has been selected to deliver two presentations at the 2015 Medidata Symposium being held from October 5th-7th
in Washington, DC. Kathy Zheng, Project Manager, will be delivering both talks. The first, entitled "Patient
Cloud®: Implementation Challenges and Other Lessons from Beyond Go-Live", will be on Tuesday October 6th at
3:30 PM and the second, entitled "Drafting an RTSM Team and Training for Go-Live" will be on Wednesday
October 7th at 11:45 AM.
PROMETRIKA's CEO and President, Dr. Miganush Stepanians noted, "Kathy has been a key participant in the
implementation of both Balance and Patient Cloud at PROMETRIKA. I am happy that she has been selected to
share the knowledge she has gained with the broader Medidata user community".
PROMETRIKA has been a partner of Medidata since 2011 and has developed processes associated with the
Medidata platform to effectively deliver the highest quality data management services.
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Full-Service CRO PROMETRIKA Expands Use of Medidata's Cloud-Based Platform to Drive
Cutting-Edge Clinical Development: Increased Adoption of Medidata's Patient-Centric Data Capture and
Management Solution Enables Significant Operational Efficiencies and New Productivity Across
PROMETRIKA's Clinical Trials
Click here to see the full press release
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PROMETRIKA Announces the Availability of Pharmacovigilance Services
CAMBRIDGE, MA, June 2, 2015 -- PROMETRIKA, LLC, a full-service clinical research organization
(CRO) has expanded its offerings with the addition of pharmacovigilance services for clinical trials.
PROMETRIKA has selected ARISg™, a world leader in safety data collection and reporting, as our service
platform. Our drug safety and regulatory affairs professionals, and expert physicians, each with more
than 23 years in the biopharmaceutical industry, provide clinical interpretation and monitoring of
PROMETRIKA's CEO and President, Dr. Miganush Stepanians noted, "In response to our Sponsors'
increasing needs for accurate and dependable safety monitoring and reporting, we now offer trial safety
monitoring with the worldwide reporting capabilities crucial in today's drug development environment."
Pharmacovigilance services for all phases of clinical trials can be provided as a stand-alone service
or in conjunction with clinical operations, monitoring, data management, biostatistics, and medical writing
services offered by PROMETRIKA.
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Join the Boston Chapter of the American Statistical Association & Boston University
Biostatistics for a Short Course on Patient-Reported Outcomes: Measurement, Implementation and
Interpretation. PROMETRIKA's Dr. Jim MacDougall, President of the Boston Chapter – ASA, hopes to
meet you there.
See the attached PDF with more details on the class.
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PROMETRIKA proudly congratulates our own Dr. Miganush Stepanians,
President and CEO, on her selection as co-chair of the Biostatistics-Data Management-Clinical
Trials (BSDMCT) working group of the Massachusetts Biotechnology Council (MassBio)
Dr. Stepanians, a biostatistician and founder of PROMETRIKA, has been selected to co-chair the
BSDMCT Working Group of MassBio. In her two-year tenure as co-chair, Dr. Stepanians and her colleagues
will develop industry-relevant programs and bring subject matter experts to MassBio's forums covering
the industry's most timely topics.
Dr. Stepanians holds an MS in Mathematics (Statistics) from MIT and a PhD in Statistics from BU.
In her 30 year career, Dr. Stepanians has been active in clinical trial design, data management systems
development, and statistical analysis of clinical trial data. She has managed the statistical analyses
of many NDA filings in varying indications and regularly represents sponsors at FDA meetings.
In addition to her current responsibilities as PROMETRIKA's President and CEO, Dr. Stepanians is
actively involved in project work for PROMETRIKA's clients. She provides trial design and statistical
analysis consulting and sits on Independent Data Monitoring Boards (IDMBs). Prior to founding PROMETRIKA,
Dr. Stepanians was Director of Biostatistics and Data Management at Muro Pharmaceuticals.
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PROMETRIKA-Boston University Partnership Helps Mentor New Talent for the Pharmaceutical Industry
On February 26th, 2015, PROMETRIKA participated in the BU School of Public Health (BUSPH) Career Fair as part of its
10-year partnership with Boston University.
PROMETRIKA's CEO, Miganush Stepanians, PhD, noted, "For PROMETRIKA, it is not only good corporate citizenship, it is a
quick and effective way to be introduced to talented future leaders of the industry. BUSPH events are always well organized
and are beneficial for our company and for the students."
As in past years, PROMETRIKA had an opportunity to introduce more than 300 current BU students to the company's expertise
and values, and to the role CROs play in the biopharmaceutical industry. For more than 40 students, it was a unique chance
to speak with PROMETRIKA Senior Biostatistician Linda Kasten. A statistician with over 25 years of experience and a BU
graduate herself, Ms. Kasten provided insights into her role at PROMETRIKA and offered invaluable advice on career opportunities.
In addition to participating in the Career Fair, PROMETRIKA supports the BUSPH internship program. Each year, three or
four BUSPH candidates for a PhD in biostatistics get practical industry experience at PROMETRIKA, working alongside experts in
clinical trial data analyses.
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The PROMETRIKA team extends congratulations and best wishes to our own Dr. Jim MacDougall
as he begins his tenure as President of the Boston Chapter of the American Statistical Association.
Dr. Jim MacDougall, a biostatistician for 21 years,
joined PROMETRIKA as a senior biostatistical consultant in early 2014. Dr. MacDougall has extensive experience in all phases of clinical research,
including multiple regulatory submissions. As a departmental head and lead statistician, Dr. MacDougall has been responsible for the scientific
and managerial success of complete clinical programs (phases 1 through 3 and submissions) in the therapeutic areas of gastroenterology, endocrinology,
medical imaging, infectious disease, neurology, and women's health. He has also been the lead statistician in many phase 1-2
oncology trials. Dr. MacDougall has been involved with many innovative statistical techniques for clinical trials, including
a novel Bayesian approach using historical data to model and impute long-term disease progression.
Dr. MacDougall has prepared for, and presented at, FDA Advisory Committee meetings, and has presented at numerous scientific
biopharmaceutical industry conferences. He is the lead or co author of many journal articles and author of a chapter in
"Dose Finding in Drug Development", published in 2006. Dr. MacDougall has been an active member of the Boston Chapter of the
ASA for over 10 years.
Prior to joining PROMETRIKA, Dr. MacDougall served as Vice President of Biometrics at Ironwood Pharmaceuticals, which he
joined in 2006. Prior to joining Ironwood, Dr. MacDougall held the position of Director of Biostatistics at Genzyme, Idenix,
and Bristol-Myers Squibb Medical Imaging. Dr. MacDougall received his Doctor of Philosophy degree in Biostatistics from the
University of North Carolina at Chapel Hill in 1999.
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Challenges of Implementing CDISC SDTM Standards for FDA Submissions
by Geeks Talk Clinical
Medidata’s Patrick Chassaigne and PROMETRIKA’s Miganush Stepanians discuss key industry trends around data management,
at the recent Partnerships in Clinical Trials conference in Las Vegas. In this video, Miganush foresees upcoming challenges for pharmas
around the conversion of existing legacy data to CDISC standards for submissions. With the FDA now mandating CDISC SDTM standards, data
should be submitted in CDISC format in order to be truly compliant. And although some companies are struggling with legacy data from
paper-based or older systems that were not CDISC compatible, many tools are now being developed to tackle those challenges. Watch the
clip for more from Patrick and Miganush.
*Guest blogger Miganush Stepanians, PhD is the President and CEO of PROMETRIKA, LLC a full-service CRO.
*Guest blogger Patrick Chassaigne serves as CRO Partnerships Director at Medidata Solutions.
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PROMETRIKA Selects Medidata Solutions as Strategic Partner
After working with Medidata Rave on nearly 20 studies, PROMETRIKA joined Medidata’s Partner Program as a Medidata Services
Partner in order to meet growing sponsor and site demand for Medidata Rave®, the industry’s leading electronic data capture
EDC) and clinical data management (CDM) system. In addition to Medidata’s market leadership, PROMETRIKA’s decision to
partner with Medidata was also driven by Rave's standards-based approach to structured data, which allows for easy conversions of
Rave-centric data into datasets for statistical analysis.
“Medidata clearly understands the business and operational challenges faced by our customer base – new and established
biotechs that are working on some of the most innovative research in the world,” said Dr. Miganush Stepanians, president
and CEO of PROMETRIKA. “We chose Medidata as a partner not only for its experience and expertise across the clinical
development process, but also for its ability to help us continue to provide the most leading-edge technologies to
our sponsor customers.”
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PROMETRIKA helps a major cancer research institute standardize EDC databases and analysis
procedures, leading to increased efficiencies in EDC startup timelines and costs
For a leading international cancer research institute, PROMETRIKA took the lead in revamping the database build process and
devising standard oncology electronic case report forms (eCRFs) based on CDISC SDTM data structures. Additionally, PROMETRIKA
developed analysis datasets consistent with a common Statistical Analysis Plan across multiple studies.
These datasets were made compliant with current CDISC ADaM standards. Additionally, legacy datasets were mapped to common
CDISC SDTM-compliant standards.
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