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Session Chair(s)
Jeffrey S. Handen, PHD
Vice President, Clinical Solutions
Medidata Solutions Worldwide, United States
Learning Objective : Discuss real-life case study examples of risk-based monitoring; Describe how to ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV.
Speaker(s)
CRO: Key Success Factors for a Sustainable Risk-based Monitoring Model
Kyle Given
Medidata Solutions Worldwide, United States
Principal, Strategic Consulting Services
Optimizing Data Quality in Clinical Trials: Performance-based Monitoring, Remote Monitoring, Reduced SDV
Vikas Gulati
Vertex Pharmaceuticals, United States
Director, Clinical Data Management
FDA Perspective
Ann Meeker-O'Connell, MS
Novartis, United States
Executive Director, Monitoring Excellence Head
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