Joint Case Study Debiopharm and Berlinger

Joint Case Study Debiopharm and Berlinger

A Revolution in Safeguarding Advanced Targeted Drugs

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Joint Case Study Debiopharm and Berlinger

From Temperature to Full Condition Monitoring - Berlinger had the privilege of implementing SmartSystem for shipment monitoring in a Debiopharm trial as a pilot project. This case study delves into the challenges faced, the innovative solutions deployed, and the tangible impact observed during the trial. The Debiopharm trial, characterized by its first-in-class approach, demanded an extra layer of precision and care in managing the investigational products.

Debiopharm is currently conducting groundbreaking research to combat difficult -to-treat cancer types with its innovative theranostic radioligand investigational medicinal product (IMP) (Debio-0228), with the aim of providing better patient treatment and value through smart drug development.

This cutting-edge drug however requires next-generation clinical supply chain management to ensure its activity and guarantee patient safety:

The active radioligand-coupled drug needs to be stored and transported at approximately -80°C in order to ensure its activity. With a shelf-life of only seven days, the transportation of the IMIP to the clinical sites is time-sensitive and any disruption or delay in the transport process may jeopardize the integrity of the IMP.

In collaboration with Berlinger, Debiopharm introduced SmartSystem for shipment monitoring into its clinical trial. Real-time location tracking combined with monitoring of environmental factors such as light, tilt and impacts to which the product is exposed allow Debiopharm to have maximum insight into the condition of the product.

Shipment planning for clinical sites could get significantly improved and preventative and corrective actions can be initiated early, ultimately resulting in better product availability at the patient, and reducing product wastage.

SmartSystem, with its state-of-the-art technology, is setting new standards for 
transparency and control in the supply chain of clinical trials.

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