Global Supply Chain Management

The key challenge clinical trial supply chain (CTSC) managers face in global distribution is ensuring that supplies arrive at the trial sites on time and in good condition. Effective distribution requires a knowledge of regulations in the country of origin and trial countries, qualified suppliers and storage infrastructure, and control of supply temperature and conditions for the duration of delivery.

Regulatory compliance

Regulatory support is a critical aspect of clinical trial supply distribution, requiring the creation and control of essential documents, study initiation, and activities to ensure a seamless supply of clinical materials. Another regulatory role is labeling management, ensuring adherence to the labeling requirements of different countries, and managing the translation of it.

When exporting clinical materials, CTSC managers must first ensure regulatory compliance with many government agencies in both the originator and destination countries.

In the United States, clearance is required from agencies such as the Food and Drug Administration, Department of Commerce, Department of Homeland Security, and Drug Enforcement Administration (DEA), as well as state agencies to ensure that materials are allowed to be delivered to destination countries, vendors, companies, and individuals, and that they are not on one of the many government controlled sanction lists or embargo lists.

DEA-regulated supplies require additional clearances in the United States and abroad. Industry-specific computer software is available to facilitate many of these functions.