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Risk-Based Monitoring: Convergence of Technology, Processes, and People
Session Chair(s)
Mary Arnould, BSN, MSN
Director, Clinical Science Operations
Astellas, United States
Real-life challenges and lessons learned. Impact on traditional roles, new opportunities, cross-functional collaboration, identifying data trends and issues.
Learning Objective : Define key challenges in RBM implementation; Describe how processes and roles need to change in the organization to support the RBM; Demonstrate how results from analytics can be turned into actionable items to mitigate risks.
Speaker(s)
Five Years of Global Risk-Based Monitoring Implementation: Where We’ve Been and Where We’re Going - Best Practices and Lessons Learned
Mary Arnould, BSN, MSN
Astellas, United States
Director, Clinical Science Operations
Risk-Based Monitoring Centralized Monitoring: What's Needed to be Effective?
Steve Young, MSc
CluePoints, United States
Chief Scientific Officer
The Evolving Area of Central Monitoring: What is it? What Data is Being Reviewed? Who is Responsible?
Keith Dorricott
Dorricott Metrics and Process Improvement Ltd., United Kingdom
MCC Ambassador; Director
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