TransCelerate BioPharma Inc. Publishes Recommendation on Use of Source Data Verification in Risk-Based Monitoring, Releases Third Update on Initiative Progress

PHILADELPHIA, Nov. 18, 2014 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate") announces the publication of its most recent manuscript on Risk-Based Monitoring (RBM), "Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials," in the Drug Information Association's  (TIRS) journal. Developed by TransCelerate's 19 member companies in collaboration with Medidata, the manuscript examines the value of Source Data Verification (SDV). Through a comprehensive literature review, a retrospective analysis of data in clinical trials, and an assessment of major/critical findings from audits, the authors conclude that SDV (transcription checking) has limited value as a quality control measure.

"The three-pronged approach in this article has shown that SDV is not the best method for managing quality in clinical trials. TransCelerate can now confidently move ahead in our RBM approaches, which use meaningful and valuable monitoring methods, including central monitoring and SDR, to focus on what matters most to the study," said Nicole Sheetz, RBM Workstream participant for TransCelerate and Advisor Clinical Innovation and Implementation, Eli Lilly and Company.

TransCelerate's RBM methodology proposes shifting monitoring processes from an excessive concentration on SDV to comprehensive, risk-driven monitoring that uses a combination of central, off-site and on-site monitoring activities. RBM includes source data review (SDR), a quality management method to evaluate critical process and to assess source documentation to ensure adequacy of the documents, protocol compliance and safety event reporting, and compliance with good clinical practices. The lessons learned from TransCelerate's RBM approach can be used to assess the critical elements for each study, and enhance patient safety and data integrity while maintaining adherence to good clinical practice (GCP).

TransCelerate also announces the release of RBM Update Volume III, which communicates new and relevant information on the accomplishments of the RBM workstream including the following: three RBM publications that further the understanding of RBM, Q2 Quantitative Performance Metrics, External Engagement Updates and Upcoming Deliverables for 2015.

TransCelerate's original position paper outlining a methodology for risk-based site monitoring was released in June 2013. The position paper, updates and all training materials can be found here.

About TransCelerate BioPharma Inc.

TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization's mission is to collaborate across the global R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of medicines. TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry and examine solutions for addressing agreed-upon common challenges.

The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research and Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit

Media Contact:

Seema Kumar  
Chair – TransCelerate BioPharma Inc. Communications Committee  
(908) 405-1144  
[email protected]