The emerging Internet of Things offers companies a complete, real-time end-to-end overview of their pharmaceutical products as they travel from manufacturer to depot and investigational site to patient.
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PAREXEL's Active Tracking service for Temperature-Controlled Clinical Supplies
Do you know if your Investigational Medicinal Product (IMP) has experienced a temperature excursion? When did you discover this? How long does it take to decide whether the medication can still be released? When it comes to the clinical trial supply chain, it’s more important than ever to have timely answers to those questions. That’s because the cost of clinical trial supply is increasing; GMP, GDP and GCP regulation is tightening; and the number of temperature-sensitive shipments (including biologics and personalized medicines) is growing. Temperature excursions can mean additional manufacturing and shipping costs to replace the product, problems with patient retention if the drug isn’t available on schedule, and risks to patient safety.
With PAREXEL’s Active Tracking service, we can monitor your product and take timely actions in the event of temperature excursions.
Active Tracking uses PAREXEL’s market leading IRT (interactive response technology) service, ClinPhone® RTSM, to provide temperature excursion alerts and reporting to clinical trial sites and automate release or quarantining of clinical trial supplies as appropriate.
For time-critical, short shelf-life products such as personalized medicines, or temperature monitoring of large shipment volumes, Active Tracking uses reusable temperature loggers in depot to site shipments that transmit temperature data and location in near real-time, enabling us to know quickly (even before arrival at the site) if your product has experienced a temperature excursion and automatically notify the site, update the material status in the IRT system and place a replacement shipment order.
For expensive, temperature-critical (often 2-8 degrees C) medication packs/kits, Active Tracking uses Bluetooth temperature loggers that are packaged within each individual pack, enabling temperature to be recorded very close to the medication and traced from the point of packaging through distribution and storage (at depots and the site) through to dispensation to patient. The loggers can be read by gateway devices in depots and by the ClinPhone RTSM mobile app at the site.
The Active Tracking service is provided with PAREXEL’s temperature controlled packaging and distribution offering from our global Clinical Trial Supplies and Logistics network, which enables proactive temperature monitoring throughout the supply chain. Active Tracking helps:
- Detect and resolve temperature excursions quickly
- Reduce the burden on clinical trial site personnel of processing medication arrivals
- Increase the security and safety of your products