Insourcing International Clinical Trials to Affiliates: A Business-Driven and Medically Sound Strategy

Abstract

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 affiliate business units and involve their local staff in the clinical development process. In the partnership model which was developed by Rhône-Poulenc Rorer Clinical Development over the past three years, worldwide clinical development plans are discussed upfront with affiliate medical directors at a clinical development board that also manages clinical program execution. Thus, medically relevant international protocols are developed. Efficiency 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.