PAREXEL International, a global biopharmaceutical services organisation, has introduced an integrated temperature recording packaging container for study drug transportation as part of its expanded Clinical Logistics Services.
PAREXEL has developed this container in cooperation with Stora Enso, a global paper, packaging and wood products company, and MediXine, specializing in multimodal communication e-services for health care and wellness.
The packaging container for study drugs incorporates a Radio-Frequency Identification (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.
PAREXEL has simplified the temperature control process by making data available for central analysis immediately upon arrival of the study drug at the investigational site. 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 (RTSM) technologies.
The packaging container can be used for monitoring drugs both in transit and at the site. With this temperature recording solution, no hardware or software installations are required at investigational sites and only a little training is needed. 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.