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The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan
Session Chair(s)
Linda B Sullivan, MBA
Senior Fellow
Tufts Center For the Study of Drug Development, United States
This session shares how group of sponsors, CROs,and RBM/data analytic vendors have explored centralized monitoring data/metric use and describes a centralized monitoring plan template that supports implementation of centralized monitoring.
Learning Objective : Explain how centralized monitoring supports the quality management approach of ICH E6 (R2); Describe some key items to consider as you develop your centralized monitoring plan.
Speaker(s)
Sponsor Perspective
Nurcan Coskun
Medtronic International Trading Sàrl, Switzerland
Global Risk Based Monitoring Program and Technology Solutions Manager / MC2
RBM Data Analytic Vendor Perspective
Keith Dorricott
Dorricott Metrics and Process Improvement Ltd., United Kingdom
MCC Ambassador; Director
CRO Perspective
Olgica Klindworth
PPD, Inc., United States
Associate Director, Data Analytics
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