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[V6-S5] CRO Management for Effective Collaboration
Session Chair(s)
Nobuhiro Koga, MBA, PMP
Director, Clinical Operation
Nihon Servier Co., Ltd., Japan
Strategic pharma-CRO collaboration aiming for quality assurance and efficiency of clinical trials has been expanded. Such collaboration is taking various forms: the number of outsourced services varies from particular service to multiple/full services; and many international pharma companies work with CROs covering different countries under single global contracts. Although sponsors do oversee as their responsibility defined clearly in the current ICH-E6R2, they do it in a wide variety of ways. In this session, we will discuss point for considerations in CRO management for more effective collaboration, including the topics of how to develop effective CRO outsourcing plans, and effective CRO managements from each perspective of pharma, medical institutions and CRO.
Speaker(s)
Local Outsourcing Strategy Planning at a Global Pharmaceutical Company
Toshiharu Sano, RPh
MSD K.K., Japan
Associate Vice President, Head of Clinical Operation Area
Effective Collaboration among Japanese Affiliates of Pharmaceutical Company and CRO under Global Contract Situation
Yusuke Yoshimoto
Eli Lilly Japan K.K., Japan
Senior Manager, Clinical Development Operations & Innovations,
Cooperation with CRO from the Viewpoint of the Institutions Based on the Investigator Initiated Clinical Trials
Yuto Fujiki, RPh
Keio University Hospital, Clinical and Translational Reserch Center,, Japan
Research Associate, Planning and Management Office
CRO Management under a Strategic Partnership from a CRO Perspective
Masakazu Kobayashi, RPh
CMIC Co., Ltd. , Japan
Head of Department, Clinical Research Dept.