The Upside of Centralized Monitoring During a Pandemic: Linda Sullivan, Duncan Hall, and Rachel Oakley on Optimizing Clinical Trials through Innovative RBQM Technology
How are clinical trial companies pivoting to implement Risk-Based Quality Management programs during the pandemic? That’s one of the deep dives explored in Duncan Hall’s and Rachel Oakley’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Hall, founder and CEO of Triumph Research Intelligence (TRI) and Oakley, Vice President of RBQM Services at TRI, note that, when the COVID-19 pandemic first hit, CROs and sites performed risk assessments on their existing studies. Then those organizations took advantage of innovative technology that had a key tool for optimizing clinical trials — centralized monitoring. According to Hall and Oakley, that tool enables critical oversight and monitoring of investigational sites, even when in-person visits are not feasible. They point out that regulatory agencies are issuing new guidance during the pandemic, and that sponsors, CROs, and sites need to figure out how to comply with both those new mandates as well as existing rules. According to Hall and Oakley, there has been a renewed sense of community in the industry in dealing with the pandemic as stakeholders try to stay current through a variety of trusted sources, including MCC’s weekly COVID calls. Finally, they note, one component for optimizing clinical trials is taking center stage — training, especially in the area of RBQM.