PAREXEL has launched its Active Tracking service designed to provide biopharma companies with near real-time temperature and location monitoring of investigational medicinal products (IMPs) from central distribution centers to clinical trial sites. The new service follows Good Distribution Practice (GDP) requirements.

An increasing number of medicinal products require a temperature-controlled supply chain to maintain product integrity during transport, including approximately 75% of biologics, 10 to 15% of small molecules, all vaccines, and a large percent of biologic samples and diagnostic tools.

The Active Tracking service uses supply chain monitoring technology to detect incidents, such as shipment delays, diversions, and temperature deviations. When combined with PAREXEL ClinPhone RTSM interactive response technology (IRT), temperature and location data is automatically sent in near real-time to clinical trial sites for assessment. This integration enables greater automated preventive or remedial actions, such as release, quarantine, and automatic re-order of temperature-controlled products.

“In the past, an investigational site had to wait until it received a shipment and downloaded the data from the temperature logger to find out if a drug’s temperature had been compromised,” said Sanjay Vyas, corporate vice president, Clinical Trial Supplies & Logistics, PAREXEL. “With PAREXEL’s Active Tracking service, we can monitor IMPs from packaging at our depots through transit to clinical trial sites, in near real-time. This innovation in clinical supply chain management allows us to quickly respond to any temperature complications, which can reduce safety risks for patients as well as manufacturing and shipment costs for clients.”