The temperature recording process adopted by Parexel is specifically designed and optimised for clinical trial supply. Using it saves 24 to 48 hours over traditional cold chain, claims Parexel, because it eliminates the need to ship temperature devices from trial sites for read out.
Joe Avellone, corporate vice president, clinical research services, Parexel, said: “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.”
A radio-frequency identification (RFID) is incorporated in the study drug’s packaging container to record temperature at pre-defined time points. The packaging container also has a dedicated compartment for a mobile phone for remote, high speed transmission of the temperature record.
When the shipment arrives at the clinical trial site staff can read out RFID tag information and transmit data to the central hub server via mobile phone. Data is reviewed by the central hub and a confirmation is sent to the site in real time.
Once it is confirmed that the drug was in the appropriate temperature range for the duration of transit the treatment can be released immediately for use in randomisation and trial supply management (RTSM).
The packaging can also be used to monitor temperature while drugs are onsite. Parexel claims the system can track more than 8,000 data points and operate for nearly 60 consecutive days. The system can record temperatures ranging from 5 to 35 degrees Celsius.