Description: With FDA’s increasing emphasis on diversity, clinical trials are more frequently conducted in global countries, increasing the expense of these already-expensive projects. Clinical supply planners are pressured to reduce costs by developing creative sourcing strategies for comparators and other study drug products. In this Solution Circle, general regulatory considerations and a decision tree to inform sourcing decisions will be presented, with opportunities to address specific cases brought by attendees.
Learning Objectives:
Understand the complexities involved with supplying other study drugs for global clinical trials
Develop appropriate regulatory advice to sourcing teams
