PAREXEL International launches temperature recording solution optimized for clinical trial supply process

PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services organization, today announced that it has introduced an integrated temperature recording solution for study drug transportation as part of its expanded Clinical Logistics Services. PAREXEL's temperature control process saves 24 to 48 hours of time over traditional cold chain methods in which temperature devices shipped out to investigative sites need to be transported back to a hub to be read out and analyzed before study drugs can be released for use. With PAREXEL's innovative 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.

Working 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, PAREXEL has developed a temperature recording process specifically designed and optimized for the clinical trial supply process. 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.

"Facing ever more complex clinical trials, biopharmaceutical companies are looking to gain greater efficiency through consistent delivery of trial-related supplies to multiple locations worldwide. This key advancement in temperature control for investigational medicines represents our commitment to ensure that clinical supplies and logistics become further streamlined, enabling our clients to reduce associated time and costs," said Joe Avellone, M.D., Corporate Vice President, Clinical Research Services, PAREXEL.

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 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.

An integral part of PAREXEL's Clinical Research Services, its Clinical Logistics Services Group provides centralized coordination of clinical trial supplies, central lab services, and ancillary supplies worldwide. Capabilities include a distribution and warehousing infrastructure to handle and transport clinical trial supplies to locations worldwide, and sophisticated technology systems to track shipments and inventory levels. The global clinical logistics team, with in-depth expertise in import and export regulations, oversees and coordinates multinational logistics. The Clinical Logistics Services are supported by enabling technology solutions, including RTSM technologies, and systems for product tracking, laboratory operations management, and warehousing.