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Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives
Session Chair(s)
Donna Dorozinsky, BSN, MSN
President & CEO
Just in Time GCP, United States
Central Statistical Monitoring in Action
Learning Objective : Discuss how a well-defined quality program can assist the investigator site in preparing for risk-based monitoring; Discuss strategies for monitoring that reflect a modern, risk-based approach; Describe an understanding of the challenges and requirements of implementing Central Statistical Monitoring.
Speaker(s)
Preparing the Investigator Site for Risk-based Monitoring
Donna Dorozinsky, BSN, MSN
Just in Time GCP, United States
President & CEO
Risk-based Monitoring: The New Regulatory Landscape and Conjectures on the Future of Clinical Trial Execution
Amanda Julie Sax, RN
Quintiles Transnational Corp., United States
Senior Director, Integrated Processes and Technologies
Central Statistical Monitoring in Action
Francois Torche, MBA
CluePoints, Belgium
Chief Product & Technology Officer
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