Risk-Based Monitoring: What Does it Mean for Clinical Study Sites?

The implementation of the principles of Risk-Based Monitoring (RBM) continues to be the subject of much discussion in the clinical development industry. Companies are developing strategies to focus their monitoring efforts on those aspects of a trial most critical to patient safety and data integrity. But what are the implications of these changes for clinical study sites?

This webinar will reveal some of the concerns that clinical study sites have regarding risk-based monitoring, including impacts to workload, budgets and monitoring support. The presenter will also discuss some of the popular misconceptions of what risk-based monitoring entails for study sites.

Key learning objectives

• Understand the concerns raised by sites regarding the implementation of risk-based monitoring practices
• Learn best practices in Site/CRO partnering to successfully drive efficiencies and improve oversight of patient safety and data quality

Speaker

Bob Bois, Director, Clinical Innovation, INC Research

Bob Bois serves as Director, Clinical Innovation at INC Research, where he is responsible for leading project teams in the development and implementation of Risk-Based Monitoring strategies. Mr.Bois has over 20 years of experience in conducting clinical trials in varying capacities: CRA, Project Manager, Safety Program Manager, and Consultant. He has worked for both sponsor organizations (pharma and device), as well as several CROs. Mr.Bois has a bachelor’s degree in mechanical engineering with a biomedical focus from Worcester Polytechnic Institute.

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