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TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
Session Chair(s)
Craig A Wozniak
Head, Americas Clinical Operations
GlaxoSmithKline, United States
TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically and uses adaptive onsite monitoring to further support subject safety and data quality.
Learning Objective : Discuss the methodology developed by TransCelerate members for quality risk management and risk-based monitoring implementation; Describe the processes, tools and operational considerations for implementation of this approach.
Speaker(s)
TransCelerate: Overview of Organization and Risk-based Monitoring Methodology
Craig A Wozniak
GlaxoSmithKline, United States
Head, Americas Clinical Operations
Pilot Implementation: Practical Experience to Date
Michael B. Luker, MBA
Eli Lilly and Company, United States
Senior Advisor