Parexel International, a global biopharmaceutical services provider, announced a new feature for its ClinPhone RTSM (randomization and trial supply management) Mobile App that addresses the workflow and safety issues commonly associated with the packaging, transport and storage of temperature-sensitive medications. The industry-first capability will provide end-to-end temperature monitoring that records the complete temperature history of a product from the point of packaging through to patient dispensation via in-pack wireless sensors.
The new offering meets a growing need for the biopharmaceutical industry to manage the increasing number of critically temperature-sensitive medications being evaluated in clinical trials (cold chain management). By 2020, it is expected that eight out of the top 10 global biopharmaceutical products will require cold chain management1. Research has shown that the majority of temperature excursions impacting medications occur during storage at the clinical site. Using wireless sensors combined with Parexel’s ClinPhone RTSM service, sites and logistics teams are able to track temperatures from the point of secondary packaging through dispensation to the patient.
“At Parexel, we continually innovate to better ensure patient safety and data accuracy while simplifying tasks for clinical trial sites. This important new functionality builds on the existing capabilities of Parexel’s Active Tracking Service and the ClinPhone RTSM Mobile App to better manage the chain of custody record for clinical supplies,” said Ubavka DeNoble, Corporate Vice President of Patient Technology Services, Parexel. “For treatments that require cold chain handling, just a few degrees can make a huge difference, potentially impacting the safety of the medication, leading to the risk of the drug being unavailable for the next patient visit or affecting patient safety. With this new offering, clients will reduce safety risks and costs associated with temperature-compromised stock.”