The new feature, available through Parexel’s ClinPhone RTSM (randomization and trial supply management) Mobile App, was developed to addresses workflow and safety concerns faced during the packaging, transport, and storage of temperature-sensitive medications.
According to the company, the update provides a complete temperature history of a product from the point of packaging to patient dispensation through in-pack wireless sensors connected via Bluetooth.
“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, which puts additional workload onto sites and sponsors,” said Colette Thorold, associate product manager, randomization and trial supply management at Parexel.
Additionally, Thorold said the new capability will also improve patient safety.
“Firstly, automated update of the IRT/RTSM system on arrival at the site means that in the event of temperature deviations being detected, a shipment reorder can be quickly placed, reducing the risk of treatment being unavailable for the next patient visit,” she told us.
“Secondly and more importantly, Parexel’s ClinPhone RTSM mobile app requires both confirmed identification (by barcode scanning) and a temperature excursion check (via Bluetooth) of the medication pack before the system allows dispensation to the patient,” Thorold added, which she said helps ensure patients receive their treatment and that it has not been temperature compromised “at any point.”