Summary: Proactive clinical supply risk evaluation and tailored strategies to support on-time study start-up for small and mid-sized sponsors
Each clinical supply project carries its own unique risks, as no two studies are exactly alike. Certain study characteristics can be leading indicators of project complexity, and are typically found in protocol design, study scope, drug characteristics and sponsor resources. Implementing an integrated and thoughtful approach to a study start up, as well as a proactive strategy to prevent issues, is essential. Clinical Supply Management (CSM) is the first line of defense in developing a sound execution plan.