戻る Agenda
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
Global Risk Based Monitoring Program and Technology Solutions Manager / MC2, Medtronic International Trading Sàrl, Switzerland
RBM Data Analytic Vendor Perspective
Keith Dorricott
MCC Ambassador; Director, Dorricott Metrics and Process Improvement Ltd., United Kingdom
CRO Perspective
Olgica Klindworth
Associate Director, Data Analytics, PPD, Inc., United States