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Parexel Tests System to Track Temperatures of Test Drugs

The biopharmaceutical services company wants to monitor the temperatures of drugs being shipped to clinical trial participants, using an RFID-enabled sensor and cell phone.
By Claire Swedberg
Sep 06, 2010Parexel International, a global biopharmaceutical services organization, has completed a proof of concept of a system using RFID to determine the technology's ability to ensure a drug's temperature has not exceeded safe thresholds while being shipped to participants in clinical trials. As a follow-up to that trial, the company plans to launch a pilot later this year that will involve tagging actual pharmaceuticals and tracking them throughout the supply chain to hospitals around the world.

Parexel will employ active RFID tags with temperature sensors and a mobile phone to access information regarding a trial product's temperatures during transit. If the follow-up study finds that the RFID system is effective at providing temperature data, the firm hopes to launch the solution for its pharmaceutical company customers. The temperature tracking would be used to ensure that new products being tested had not been too warm or too cold during shipment from manufacturers to clinical locations where the drugs are being administered.

For its upcoming pilot, Parexel will pack drugs in a cardboard boxes that contain a temperature sensor wired to an RFID tag embedded in the box's side.

For the past three years, says Jens Mattuschka, Parexel's director of clinical logistics services worldwide, the company had been considering the implementation of an RFID solution to track the temperatures of new medications being transported to the locations of clinical trials for the pharmaceutical industry. For a trial involving a single drug, Parexel may ship the product being tested to hundreds or thousands of locations around the globe at which trials are held. The drug is typically manufactured in a small quantity, and then sent to those locations, shipped either by truck or air. Part of the service that Parexel provides is ensuring that the temperature does not exceed safe thresholds while in transit.

Clinical trial medications can be sensitive to temperature changes, and the level of that sensitivity may not be as well known as that for approved medications. Therefore, it is critical to have temperature data for some of these products before they given to patients. Verifying that the drugs have been stored at the proper temperature, says Kurt Norris, the company's corporate VP, ensures that the medication quality has not been adversely affected—something that could pose a health risk for those who take the medication as part of a trial.

Currently, therefore, the process typically requires that a box of product be shipped with a temperature logger inside the box, in order to read the temperature. When the investigator or physician (the individual who will be conducting the trial) opens the box, he or she must remove the logger, read it visually and input the temperature displayed on that device into a software program designed by Parexel for tracking the drugs' temperature. That individual must then send that information via the Internet to Parexel's server, where it must be reviewed, analyzed and either approved or rejected. Alternatively, data can be downloaded via a USB interface to a computer, and then be uploaded to the Parexel server via the Internet.

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