Risk-Based Monitoring: It's Not About Taking Risks — It's About Managing Risks
Miguel Valenzuela is head of business intelligence and oversight at Bayer HealthCare’s global clinical development organization, and Bayer’s risk-based monitoring (RBM) implementation leader. He presented during the 2013 European Medidata user Group (E-MUG) conference on the framework and process of implementing an RBM program, as well as the challenges and evaluation factors. Miguel also participated in the E-MUG site management and monitoring panel discussion on the implications of the Transcelerate risk-based monitoring position paper. Held in Florence, Italy, the panel discussion also included INC Research’s senior director of clinical innovation Jill Collins, Sanofi Pharmaceutical’s assistant director of global clinical study unit Lori Convy and Medidata’s senior product director Steve Young. In this video, Medidata’s Claribel Pichardo chats with Miguel about his experiences at E-MUG, the impact RBM can have on clinical sites, and how it's not about taking risk, it's about managing risks. *Miguel Valenzuela is head of business intelligence and oversight at Bayer HealthCare.