Four Easy Steps for Validating the Integrity of Clinical Trial Pharmaceuticals in Last-Mile Distribution

Clinical trials play a vital role in providing the pharmaceutical industry with safe and effective ways to slow down and even eradicate the spread of viruses, diseases and other life-threatening conditions.

Clinical trial sponsors—pharmaceutical manufacturers, government agencies and clinical research organizations—use these trials to determine if a drug is safe and effective; what side effects may occur; and if there are variances within different trial populations.

To help assure the integrity of the process, any temperature-sensitive drugs in trial kits must be monitored during distribution to assure that they have been kept in a safe temperature range. Pharmaceutical cold chain monitoring not only validates that the drugs meet regulatory requirements, but also, and more importantly, it assures the drugs are safe to administer to patients and that the trial results are valid.

Proof of Temperature Control in Four Easy Steps

As the COVID-19 pandemic evolved, clinical trial sponsors started conducting decentralized and hybrid clinic trials. This now means that the trial kits are delivered directly to hospitals, clinics, medical offices or participating patients’ homes.

Because of this process change, sponsors must assure the safety of the drugs in this “last-mile” of distribution and validate their temperature control—and now they can do that through these four easy steps, thanks to Bluetooth^® technology.

1. Embed a monitoring device in the kits. Before distributing the kits in the last mile, sponsors can embed a Bluetooth-enabled monitoring device in the trial kits to monitor the temperature of the drugs as they are transported. Any temperature excursions while the kits are in route will be recorded automatically.
2. Capture a touchless temperature reading. Using an intuitive, easy-to-use app that is available on any Android or iOS mobile device, anyone involved in the last mile of distribution—whether it’s a delivery driver, a clinician or a patient at home—can get a quick, touchless reading of the temperature of the drugs in the kit. The app detects the monitoring devices in the trial kits via Bluetooth connectivity and downloads temperature data to the app. The app can read the monitoring devices from up to 30 feet away, eliminating the need to open any thermal protective packaging during the monitoring process.
3. Get immediate temperature status. Viewing a trial kit’s data provides at-a-glance alarm status, along with detailed temperature statistics for the pharmaceuticals. This reading demonstrates whether the pharmaceuticals in the kit have been transported in an ideal, compliant temperature range based on predetermined protocols. If they have, the kits can be accepted. If there was an excursion during transport—where the temperature of the pharmaceutical exceeded the high or low acceptable limit—users may be instructed by trial sponsors to reject the kits.
4. Transfer temperature data seamlessly. As the data from the kits is viewed, the recorded temperatures are automatically transmitted to a trial sponsor’s system of record to provide proof of temperature compliance and regulatory audit documentation. A certificate of calibration for each monitoring device can be shared from the app to document temperature-monitoring accuracy.

TempTale^® Ultra BLE Makes Monitoring Easy and Efficient

Sensitech now offers a TempTale^® Ultra BLE solution, with easy-to-use, cost-effective Bluetooth connectivity for temperature monitoring of clinical trial kits during last-mile distribution. The TempTale Ultra BLE solution includes:

• A compact validated monitoring device that fits in each trial kit to monitor the temperature of the pharmaceutical. These monitoring devices, which broadcasts data via Bluetooth connectivity, are individually calibrated to a 3-point NIST^® traceable standard to ensure accurate temperature monitoring.
• An intuitive mobile app compatible with Android or iOS devices, which can wirelessly read data from the devices in the clinical kits, and display which kits have alarmed, triggering an accept/reject decision. The app has the added ability to transfer monitor data from the device wirelessly to the cloud system of record for storage with one tap.
• A validated system of record that securely stores the information from the temperature-sensitive clinical supply shipments. The data can be used for regulatory audits as well as analysis of temperature control for process improvements.