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Risk-Based Monitoring Symposium
Session Chair(s)
Marcus Thornton
Senior Director, CTMS, Medidata Solutions Worldwide, United Kingdom
Occupying the White Space Between the Clinical Data Manager and the Clinical Research Associate
Learning Objective : Assess how onsite and remote monitoring and centralized site quality management functions are influenced by technology, analytics, and benchmarks; Demonstrate a model for collaboration between data managers and CRAs that optimizes site performance and delivers higher quality site captured data at a lower cost; Discuss how to evolve from the traditional CRA role into a risk-based monitoring world where there is interplay between remote, central, and onsite monitoring activities.
Speaker(s)
Marcus Thornton
Senior Director, CTMS, Medidata Solutions Worldwide, United Kingdom
The Role of the Monitor: Considerations to Adopting a Risk-Based and Adaptive Monitoring Program
Dermot Kenny
Executive Vice President, Global Clinical and Data Operations, ICON, Ireland
Occupying the White Space Between the Clinical Data Manager and the Clinical Research Associate
Rita Purvis
Vice President, Clinical Operations, inVentiv Health Clinical, United States
De-Risking Your Risk-Based Monitoring (RBM) Plan: Practical Considerations in Implementing RBM at the CRA Level
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