Speakers: Tom Grundstrom, Quintiles, Vice President, Integrated Processes and Technologies
Amanda Sax, Quintiles, Senior Director, Integrated Processes and Technologies
Risk Based Monitoring (RBM) is an accepted method covered by FDA draft guidance and an EMA reflection paper. This approach involves adjusting the monitoring strategy based on level of risk, reflecting the reality that 20% of clinical trial sites contribute to 80% of quality issues.
The speakers will provide a definition of RBM, insight into the regulatory landscape, and a perspective on executing RBM leveraging three elements: people, processes, and technology.