Monitoring fills a critical need in clinical trials by supporting subjects’ safety and ensuring reliable results. But with recent regulatory guidance and the emergence of more innovative technological systems, our industry is witnessing more efficient methods to increase compliance and improve data integrity through risk-based monitoring (RBM).
Join us as we discuss the guiding principles of risk-based monitoring and how it differs from traditional methods. We’ll cover the major drivers of change that have propelled the shift from manual methods to more automated, technology-driven risk assessments through analytical tools like Xcellerate® Monitoring.
The webinar will also go through several case studies to explore the evolution of RBM as it has gained greater industry acceptance, along with recent success measures that demonstrate its overall effectiveness. Practical pointers will cover planning and launching an RBM study, steps for quality by design, ongoing risk reviews and lessons learned from incorporating reporting data retroactively.
If you would like to build more efficiencies into your monitoring practices and hear about the advantages of proactively identifying and mitigating potential risks, register for this webinar and learn how our industry approaches RBM in clinical trials.
Presented by
Adam Baumgart,
Senior Director of Monitoring & Data Flow Optimization
Adam has spent 26 years in clinical research through roles in pharma, an EDC vendor and several major CROs, gaining deep experience in risk-based monitoring, process excellence, project management, clinical data management and clinical monitoring. At Covance, he leads Covance’s full service RBM and central monitoring team, which implements RBM tools and processes on client studies.