PAREXEL International Corporation has announced the launch of its Active Tracking service. The service follows Good Distribution Practice (GDP) requirements by providing biopharmaceutical companies with near real-time temperature and location monitoring of investigational medicinal products (IMPs) from central distribution centers to clinical trial sites.
An increasing number of medicinal products require a temperature-controlled supply chain to maintain product integrity during transport, including approximately 75 percent of biological drugs, 10 to 15 percent of small molecule therapies, 100 percent of vaccines, and a large percent of biologic samples and diagnostic tools. Temperature deviations and shipment delays can impact patient safety, create patient retention issues, and cause additional manufacturing and shipment costs.
Supported by PAREXEL's Clinical Trial Supply & Logistics global depot and service network, PAREXEL's Active Tracking service utilizes supply chain monitoring technology to detect incidents, such as shipment delays, shipment 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, simplifying temperature management for sites and sponsors.
"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."