Operating clinical trial supply chains involving high value, low stability products is fraught with complexity and risk. Not only must sponsors ensure production environments, protocols and materials are fit for purpose, they must guarantee appropriate temperature ranges are maintained throughout a product’s lifecycle, including during transit and site storage where the risk of excursions intensifies.
The way sponsors approach the capture and management of temperature data influences the level of risk they accept into their supply chains. Managed manually in a silo and the risk – as well as the associated costs, delay and disruption - of non-compliance increases. Contrastingly, if managed as part of an integrated supply chain system approach, which unifies data to inform smart decision making, risks can be mitigated, patients protected, and timelines kept on track.
Key Learning Objectives
- Understand the fundamentals of mitigating the risks of temperature excursions
- Learn how to effectively develop system integration to promote robust temperature control
- Identify the benefits of managing temperature management risk with supply chain system integration
