Expert Perspective: Navigating Regulatory Challenges In Ancillary Supply Management

Ancillary supplies encompass everything needed for a clinical trial beyond the investigational medicinal product (IMP), yet issues with these materials can delay a study just as quickly as a problem with the drug itself.

In this Q&A, Caitlin Smalley, Regulatory Affairs Specialist, and Molly Isermann, Senior Manager of Product Management, both part of Thermo Fisher Scientific’s Clinical Ancillary Management team, share their experience supporting global studies. They explore regulatory challenges that can catch trial teams off guard, from country-specific medical device requirements to the documentation burden involved in study closeout. The conversation also examines a client’s experience selecting an infusion adapter that was not suitable beyond its original US scope, illustrating the importance of considering requirements across different markets. Smalley and Isermann also discuss how evolving marking standards and trade rules can complicate planning and decision-making.

Read the full conversation to learn where they see common missteps begin and what challenges teams should consider when managing ancillary supplies across global clinical trials.