ICH GCP E6 (R2) guidelines have made it mandatory for sponsors and their partners to implement a risk-based approach to trial oversight. The widespread adoption of a thorough risk based monitoring (RBM) strategy has no doubt enabled sponsors to develop methods to address risks associated with the conduct of a clinical trial.
However, we believe that a comprehensive, quality-centric approach to clinical trial oversight includes more than risk-based monitoring. Imagine if you could monitor not only risk, but Total Trial Monitoring (TTM). TTM is a larger monitoring strategy that Covance has developed to identify and mediate risk, but TTM looks at the entire trial to help you develop/differentiate an individualized approach to:
► Quality-by-Design
► Site monitoring (Interval, variable, adaptive or triggered)
► Centralized monitoring
► Risk, medical, statistical & holistic data review
Join us for an informational webinar, led by our Executive Director of Central Monitoring, Michael Walega, as he discusses why Covance has chosen to implement a total trial monitoring approach, and why this is the “new” RBM.
You won’t want to miss it
Michael Walega,
Executive Director, Monitoring and Data Flow Optimization, Covance
Mike has more than 35 years of experience in academic and clinical research, and in his current role he leads Covance’s Central Monitoring team and oversees the development of the Xcellerate® Monitoring suite of applications.
During his 19+ years at Covance Mike has held positions of increasing responsibility, most recently as a Six Sigma Master Black Belt leading a team of process improvement experts, and as the Executive Director for Biometrics Operations, overseeing a team of 80 skilled statisticians and programmers charged with delivering the analysis and reporting of data collected from clinical trials. His work has resulted in more than 40 refereed publications and podium presentations.
He was one of the original members of the CDISC SDTM team and represents Covance on the ACRO RBM work stream. He received his MSc in Biostatistics from New York Medical College.
- Why RBM is larger than just risk monitoring
- How to holistically manage your entire trial using a Total Trial Management approach
- How to utilize a new RBM approach to meet ICH GCP guidelines
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