How to Vet Importer of Record Partners for Clinical Trials

Managing customs and importation in global clinical trials requires more than logistics contracts, according to Christy Owings, vice president and general manager of the Americas business unit at Thermo Fisher Scientific. Owings connected with PharmTech to discuss how sponsors should approach importer of record planning at the protocol design stage rather than treating it as an afterthought.

Owings emphasizes that clinical trial sponsors need local, on-the-ground expertise when navigating customs authorities in unfamiliar markets. Clinical materials carry regulatory and patient-safety stakes that demand a different level of oversight.

That oversight comes down to relationships and accountability. "I want to know that I can contact a person who knows the process and is able to leverage and advocate on my behalf there in country," Owings says. She points to a depot's track record with customs officials as a factor sponsors should weigh: repeated importations tied to a known, compliant address build the kind of trust that keeps shipments moving without delay.

Owings' broader point centers on partner selection. Working with an organization that has physical infrastructure, such as brick-and-mortar depots, in the regions where a trial operates gives sponsors direct lines of communication when customs questions arise, rather than relying on intermediaries unfamiliar with local requirements.

For CMC, quality, and clinical operations teams weighing importer of record strategy, the discussion underscores a recurring theme in global trial logistics: early planning and local presence reduce the risk of costly customs delays down the line.