By Kristen DeVito, Global Director, Clinical Supply Services Business Solutions & Jan Ehrich, Senior Clinical Supply Manager, Catalent Pharma Solutions
Clinical supply management has many challenges. Clinical trials have many moving parts and clinical supplies need to be prepared well in advance of the actual study start. Supply delays, stock-outs or excess inventory are all undesirable and potentially risky scenarios. In recent years, clinical studies have become more global and complex – involving a multitude of clinical sites and network depots spanning multiple countries and geographic regions, each with a unique set of challenges and requirements. When more countries and regions are added or dropped during a study, clinical supply management activities such as forecasting become important as they can plan for and guide an appropriate response to such changes.
Study protocols themselves are also becoming more complex. Studies that in the past were treated as separate clinical trials are now being combined to accelerate the clinical development process. As an example, dose escalation and maximum tolerated dose safety studies are being integrated with pharmacokinetics and pharmacodynamics studies to form a single clinical trial. New approaches to study protocol designs such as adaptive trials and specialized basket/bucket studies (used in oncology studies) can increase clinical supply complexity.