Real-time Data Tracking in the Clinical Trial Supply Chain
It’s 2016: airplanes, ships, trains and even cars send a constant mass of sensor data to central servers. Almost 50% of the world’s population uses a smartphone. We communicate with these mobile computers continually, globally.
So what is the biopharmaceutical R&D industry doing in terms of data in the clinical trial supply chain? Ninety-nine per cent of all temperature controlled shipments are equipped with a validated temperature logger — which will be activated at point A, deactivated at point B, the data read out and then a PDF version of the temperature curve sent out by e-mail to facilitate manual drug release procedures.
Good Distribution Practice (GDP) has meant that ‘track and trace’ is becoming indispensable for drug product integrity. The market for biological products is also growing — consequently, cold chain solutions demand is also increasing.
Interactive Response Technologies in the future may have the potential for data tracking from transport start to finish and fulfill the vision of real end-to-end (e2e) temperature tracking. This starts with facility monitoring (for instance, at the manufacturing site) and ends at the investigational site, and, in future, in the patient’s home. Temperature data is sent in frequent intervals, along with geofencing parameters, when the loggers connect to a telephone network. How does this work during flights? Quite simply, the loggers detect the environment, notice whether they can send out data or not and, in this case, they would collect data in flight and transmit it after landing. Such near real-time logging devices can also collect data on other environmental quality factors such as humidity, pressure, light (to detect a package being opened), and acceleration (used both to detect when in-flight but also to detect the package being dropped).