
- Applied Clinical Trials-06-01-2013
- Volume 22
- Issue 6
TransCelerate Offers its Position on RBM
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:
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 The position paper was developed in response to draft guidance from the FDA and EMA, and both agencies have reviewed the paper.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
Articles in this issue
over 12 years ago
ACT Coverover 12 years ago
It's a Man's World—and it Shouldn't Beover 12 years ago
Business and People June 2013over 12 years ago
PDUFA V Changes To Speed Drug Development and Approvalsover 12 years ago
Integrating Patient Retention Strategiesover 12 years ago
Network Meta-Analysis Can Play Decisive Roleover 12 years ago
Research in the Age of Transparencyover 12 years ago
Type 2 Diabetes Community-Based Recruitment StrategiesNewsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.