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[Session 4] The Way of Centralized Monitoring
Session Chair(s)
Yukikazu Hayashi
Assistant Head of Clinical Development
A2 Healthcare Corporation, Japan
Kyoko Minamoto
Medical Technologist
National Cancer Center, Japan
Clinical trials are expected to be conducted founded upon the ideas of QMS and RbM now that ICH-GCP E6(R2) is under discussion for amendment. As a result, centralized monitoring has gained increased attention in recent years. This session will discuss centralized monitoring across various points of view and try to determine what roles data managers can take and what kind of future monitoring we will move into.
Speaker(s)
Rethinking the Clinically-Based Thresholds of TransCelerate BioPharma for Risk-Based Monitoring
Richard Zink, PhD
JMP Statistical Discovery, United States
Principal Research Statistician
Future Challenges of Central Monitoring
Emi Yamada
Astellas Pharma Inc., Japan
Sr. Manager, Japan/Asia Clinical Development 1
Matrix Analysis of RBM Activities, Skills and Roles
Kenji Fujisawa
Kowa Company, Ltd., Japan
Koji Oba, PhD
The University of Tokyo, Japan
Associate Professor, Dept of Biostatistics, School of Public Health
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