TransCelerate BioPharma has provided the first update to its position paper on risk-based site monitoring, released last June. The update is a result of continued refinement of the position paper's concepts and assessing the experiences and lessons learned by the TransCelerate member companies that piloted the RBM methodology.
"Through piloting TransCelerate's RBM methodology, framework and tools, we have sought to manage clinical trial risks through identification, categorization and appropriate mitigation," said Rehbar Tayyabkhan, Executive Director at Bristol-Myers Squibb and RBM Project Lead for TransCelerate. "We have learned important lessons from our member companies and regulatory agencies on tools like the RACT (Risk Assessment and Categorization Tool), which will help companies identify and plan their risk mitigation strategies, and a focus group has been tasked with assessing the feedback and implementing changes to the tool. We also have received valuable feedback on our pilot study monitoring plans."
You can read the full release here.