Project Management: A Clinical Perspective

Abstract

The clinical phase of drug development involves many steps and takes years to complete. A structured team approach was developed at Wyeth-Ayerst to streamline the process and avoid lengthy delays and nonproductive work. The implementation of a clinical project team that interacts with all facets of clinical drug development has greatly improved communications among all groups involved. This mechanism allows for more timely decisions and increases work efficiency. The main coordinator of the clinical project team is the clinical project administrator. With detailed planning and tracking, the project administrators keep all phases of the clinical development on track. With the need for global drug development, coordination of clinical studies internationally reduces costs by eliminating repetitive studies. The implementation of clinical project teams has reduced the time needed to complete the clinical phases of drug development by 25%.