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Clinical Trial Optimization Podcast

Outsourcing Oversight of RBQM in Clinical Trials with Liz Wool and MCC’s Linda Sullivan


How can sponsors with limited resources successfully outsource RBQM? That’s one of the key topics explored during Linda Sullivan’s interview with Liz Wool, founder, and president of the Wool Consulting Group. Wool is a recognized industry expert on CRO-vendor oversight and management, certified CRA (ACRP), and an instructional designer, master trainer and expert in delivering virtual training courses that engages the learners. Wool and Sullivan discuss the evolution of risk-based quality management and the regulatory challenges faced by both large and small sponsors. Small sponsors face several problems if they outsource RBQM – they often don’t have the expertise to be an effective partner in RBQM, Wool notes. They need to work with a consultant who can upskill and train them to establish RBQM expectation with their CRO. Key factors in successfully outsourcing RBQM is to work in multi-disciplinary teams, not silos, and to fully understand the methodology being used by the CRO.

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