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.What range of temperatures was the shipment exposed to during transport? Were the specified temperature limits of the transported freight exceeded? Can the goods be released or is the quality affected?
These are important questions which arise in the context of cold chain monitoring and the GDP (Good Distribution Practices) guidelines. Targeted, reliable, uninterrupted temperature monitoring and recording is therefore essential for comprehensive quality assurance in logistics. The transport of temperature-sensitive goods poses a particular challenge for everyone involved, especially when multiple companies are involved in transhipment processes or various transportation methods are used.