PAREXEL International Corp., a global biopharmaceutical services organization, announced that it has developed an integrated temperature recording solution specifically designed for clinical trial supply processing and transportation.
The packaging container incorporates an RFID tag for temperature recording and dedicated compartment for a mobile phone, providing automatic tracking and remote, high-speed transmission of the complete temperature record. The RFID tag records study drug temperature at pre-defined time points, while a mobile phone application and web-based portal allow secure, controlled data transmission and access to temperature data in real-time between a central hub and an investigative site.
Traditional cold chain methods require temperature devices to be shipped out to investigative sites and then transported back to a hub to be read out and analyzed before study drugs can be released for use. With PAREXEL’s approach, a central hub receives and disseminates confirmations of temperature data in real-time, allowing clinical site investigators to quickly begin using study drugs according to trial protocols.
No hardware or software installations are required at investigative sites and little training is needed. Site staff reads out RFID tag information and transmits data to the central hub server via mobile phone. The central hub reviews the data and transmits a confirmation back to the site in real-time. If the temperature was in range during transportation, the study drug can be immediately released to use within randomization and trial supply management technologies.
The packaging container can be used for monitoring drugs both in transit and at the site. Designed to provide temperature recordings at flexible intervals between 5 to 35 degrees Celsius, the solution can track over 8,000 data points and operate for nearly 60 consecutive days.