World Class Clinical Supplies

Abstract

Clinical studies are getting larger, longer, more complicated, and more internationally dispersed. At the same time, pharmaceutical companies are compressing the time and cost of the overall research and development (R&D) process. The clinical supplies process is one of the activities where these two trends collide. Planning, manufacturing, and distributing supplies is often on the back burner, compared to other activities such as investigator selection. If time and cost reduction leads to delays in pivotal or lifesaving studies, however, it can quickly become a top priority. This article describes some of the leading practices identified during the authors' process improvement work in clinical supplies areas with several large pharmaceutical companies. It also provides an organizational self-assessment tool to identify areas for improvement.