TransCelerate BioPharma Inc., an independent non-profit organization focused on accelerating the development of new medicines, has released a position paper outlining a methodology for risk-based site monitoring (“Risk-Based Monitoring” or “RBM”) that could significantly modernize and streamline the way studies are conducted and monitored.
TransCelerate’s recommendations are driven by centralized and off-site monitoring techniques, as well as adaptive on-site monitoring. This approach makes it possible to oversee study parameters holistically and maximize on-site monitoring findings, bringing into balance effort and value gained, while mitigating risks and detecting any issues early, or preventing them entirely.
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 The position paper was developed in response to draft guidance from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Both agencies have reviewed the RBM methodology paper and TransCelerate looks forward to the agencies’ final guidance documents.