Insourcing International Clinical Trials to Affiliates: A Business-Driven and Medically Sound Strategy
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0092-86 I5/2000 Copyright 0 2000 Drug Information Association Inc.
INSOURCING INTERNATIONAL CLINICAL TRIALS TO AFFILIATES: A BUSINESS-DRIVEN AND MEDICALLY SOUND STRATEGY PHILIP CHAIKIN,PHARMD,MD, FCP Vice President, Worldwide Corporate Clinical Development, RhBne-Poulenc Rorer. Collegeville, Pennsylvania
SYLVAIN DURRLEMAN, MD, PHD Vice President, Worldwide Biostatistics, Data Management and Clinical Operations, RhBne-Poulenc Rorer, Antony, France
FLORENCE BERGER,PHARMD Director, Worldwide Clinical Operations, RhBne-Poulenc Rorer, Antony, France
JOHANREINHOUDT,RN, BS Senior Manager, Worldwide Clinical Operations, RhBne-Poulenc Rorer, Collegeville, Pennsylvania
IBRAHIM FARR,MD, PHD, FFPM Medical Director, RhBne-Poulenc Rorer. Scientific Department, Madrid, Spain
MARTINFORD,MD, FFPM Medical Director, RhBne-Poulenc Rorer, West Malling, United Kingdom
In order to ensure commercial success, clinical drug development has to be medically sound while taking into account business needs. Clinical trials must be conducted in a multinational setting in compliance with regulatory standards and in a timely fashion. One way of achieving these goals is to develop a partnership with medical directors in the afiliate business units and involve their local staff in the clinical development process. In the partnership model which was developed by RhBne-Poulenc Rorer Clinical Development over the past three years, worldwide clinical development plans are discussed upfront with afJiliate medical directors at a clinical development board that also manages clinical program execution. Thus, medically relevant international protocols are developed. Eficiency is improved by decentralizing appropriate parts of the study management process. High standards of quality are guaranteed via standard operating procedures and guidelines within a global quality system. Resource and capacity planning ensures that time and cost targets are achieved for key projects. Insourced resources are managed using performance indicators designed to accelerate development and control costs. Theperformance of this business model was evaluated on an ongoing basis against internal and external benchmarks and found to be a cost-effective and viable strategy for achieving the mission of Worldwide Clinical Development.
Reprint address: Florence Berger, PhannD, RhBne-Poulenc Rorer, Clinical Operations 20, Avenue Raymond Aron, 92165 Antony cedex, France.
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P. Chuikin, S. Durrleman, F. Berger, J. Reinhoudt, 1. Farr, and
M. Ford
Key Words: Clinical development; Affiliate medical department; Outsourcing; Clinical development plan; Study protocols; Clinical study management; Resource management; Performance measures
INTRODUCTION THE MISSION OF clinical development is the timely and resource-efficient preparation of quality New Drug ApplicationsMarketing Authorization Applications to ensure successful registration and commercialization of medically important products. This paper d
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