Once finished, the investigator pressed a button on the mobile phone to instruct the phone's software to transmit the data to Parexel's server via a
GSM connection. Parexel software then interpreted the
sensor data, and if the software detected a temperature outside of the acceptable range, it issued an alert to Parexel's staff. Had this been an actual clinical trial, and had the temperature throughout the supply chain proven to be acceptable, the product would then have been approved for use by the trial's participants—with the entire process completed in a matter of minutes, rather than the 24 hours required when using the manual method.
During the proof-of-concept study, Mattuschka says, the liquid was shipped in the
NFC-enabled packaging from Europe to 10 to 20 locations in Latin America and the United States. The technology properly tracked temperatures throughout the journeys, he adds, which extended up to 72 hours.
For the follow-up study, expected to be held later this year, the company will identify one clinical pharmaceutical product, and track it to the investigators or physicians who will conduct clinical trials for the biopharmaceutical industry throughout the world. Each investigator will receive training for the handling of clinical trial pharmaceuticals—and in this case, the training will include how to operate the cell phone to
read and then transmit temperature data to Parexel's server.
Eventually, Norris says, Parexel would like to use
RFID technology to track temperatures for all clinical trials involving temperature-sensitive products. The system will provide cost savings, he indicates, by reducing the amount of labor needed to read, interpret and input temperature data. He adds that it will also save time, by reducing the amount of time that investigators must await temperature results. What's more, the system will enable greater visibility not only into a product's temperature range, but also when the temperature changes occur, and when the product is shipped and then received.