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

How can sponsors with limited resources be most successful in 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. For more on this topic, check out MCC’s website,  https://metricschampion.org. While you’re there, also check out the upcoming MCC Virtual Summit, at which Liz Wool will be running a mini workshop on this topic, www.mcc-summit.com