A Systems Infrastructure for Sponsor/CRO Collaboration on International Clinical Trials

Abstract

Genentech Medical Affairs and Corning Besselaar have built an information systems infrastructure to support their collaborations on international Phase III clinical trials. With the goal of speeding up the clinical development process, information technology is being used to more effectively link distributed team members from multiple companies and countries.

Two key lessons emerge from this experience: 1. A well-supported IT infrastructure can make a real contribution to accelerating clinical development, and 2. There must be human coordinating processes in place between the many participating groups in order to manage and support each aspect of the systems infrastructure and the end-to-end workflow. This paper reviews the genesis of the collaboration between Genentech and Corning Besselaar, outlines elements of the systems infrastructure and coordinating processes that were put into place, and concludes with some of the lessons learned from its use to date.