TransCelerate Offers its Position on RBM

June 1, 2013
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2013, Volume 22, Issue 6

Risk-based monitoring was in Trans-Celerate BioPharma's sights since the pharmaceutical company collaborative was announced in September 2012.

Risk-based monitoring was in TransCelerate BioPharma's sights since the pharmaceutical company collaborative was announced in September 2012. TransCelerate made good on its promise and delivered its first position paper early this month and can be accessed along with the public review survey here: http://bit.ly/182ItxJ. The organization's 16 member companies will pilot its RBM methodology, with multiple pilots already in motion. Following completion of pilot activities, TransCelerate plans to issue a future position paper clarifying the effectiveness of its approach.

According to TransCelerate, the RBM paper outlines a standard approach for risk-based monitoring that can be adopted for any type, phase, and stage of clinical trial, resulting in enhanced patient safety, quality clinical data, and new efficiencies. The position paper was developed in response to draft guidance from the FDA and EMA, and both agencies have reviewed the paper.

TransCelerate's RBM methodology provides a framework and tools to help identify, manage, and mitigate clinical trial risks. The tools include the Risk Assessment and Categorizaton Tool and the Integrated Quality and Risk Management Plan. Rehbar Tayyabkhan, Executive Director at Bristol-Myers Squibb and RBM Project Lead for TransCelerate, said, "We also are sharing an approach that enables a balance between off-site/centralized study monitoring and on-site activities at the investigative site. This allows for a more targeted approach."

Tayyabkhan will be on hand in late October at CBI's Risk-Based Monitoring in Clinical Trials conference to discuss TransCelerate's risk-based work stream, the processes and operational considerations, as well as future expectations. Tayyabkhan will be joined on this panel by Andy Lawton, Global Head of Data Management, Boehringer Ingelheim, and Craig Wozniak, Vice President, North America Clinical Operations, GlaxoSmithKline. To learn more about the conference, please visit www.cbinet.com/RBM.

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