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Clinical Trial Optimization Podcast

RBQM’s Maturity Model with Sam Sather of Clinical Pathways and Linda Sullivan


Sponsors should approach Risk-Based Quality Management (RBQM) implementation focusing on supporting some important critical factors, including company culture, trial design, trial operations, as well as continuous improvement. That’s one of the key takeaways from Sam Sather’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Sather co-founded Clinical Pathways, a North Carolina-based consulting firm and is the company’s Vice President who leads quality management consulting services. RBQM is dynamic and should be embedded in all aspects of a stakeholder’s operations and decision-making, notes Sather. RBQM is not an optional activity or intermittent, she explains, and needs cross-functional representation. Finally, Sullivan and Sather take a deep dive into the differences between how small and large sponsors implement RBQM which varies based on how companies view risk-taking, what is at stake for success, access to data, outsourcing strategies, and regulatory inspection experience. Whatever you do, Sullivan and Sather conclude, document it.

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