Case Study with Merck KGaA and Berlinger

The main aim of sponsors when conducting a clinical trial is to deliver the Investigational Medicinal Product (IMP) to the patients in the quickest, most efficient, and safest way possible. The best approach to achieve this is to implement uninterrupted temperature monitoring in the IMP supply chain, starting from IMP packaging and including IMP storage at site. This will simplify executing processes and facilitate decision-making on whether the IMP is still fit for use and thereby secure patient safety.

Berlinger had the opportunity to implement the SmartView end-to-end temperature monitoring system within one clinical oncology study conducted by the healthcare business of Merck KGaA, Darmstadt, Germany.

Before the clinical study started, the sponsor had a manual process where the temperature measurement process was fragmented and did not allow for efficient cumulative tracking. Simultaneously, the whole process was documented on paper basis, which is more time-consuming and prone to human error. This might cause delayed decision-making, due to the lack of online access to all necessary data along the supply chain. Ultimately, the nature of non-digital processes could potentially lead to costly expedited shipments, delayed patient treatment, drug wastage and potential risk of compromised compliance with regulatory requirements.

Berlinger understood the weaknesses of the process faced by the sponsor and engaged in a collaboration with all stakeholders involved in the study supply process to make sure that our client’s QA (= Quality Assurance) department could work more efficiently.

Thanks to Berlinger’s open SmartView platform, it was possible to integrate the Berlinger system with the IRT platform that helped Merck KGaA, Darmstadt, Germany to gain online access to the cumulative overview of IMP temperature data during storage and transport. This allowed all stakeholders involved to maintain one platform, with one dashboard and full oversight of the complete temperature history of the IMP.

The key to success in this project was the collaboration between different stakeholders involved in the study such as the sponsor, the CDMO, the CRO, the sites, and their IRT partner. Learn about the value of implementing end-to-end temperature monitoring and assessment in your clinical trial supply chain in the white paper.

In the case study, the technical background of Berlinger’s SmartView end-to-end temperature monitoring and assessment solution, and the benefits of implementing it in the clinical trial for each stakeholder will be discussed. The content outlines the lessons learned from the implementation of Berlinger SmartView solution and gives an outlook for the future and a sneak peak of what is to be expected next from end-to-end monitoring in the clinical trials industry.

► Learn more in the webinar with Silke Leiser from Merck KGaA and Harald van Weeren from Berlinger & Co. AG