The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber—from packaging, handling, storage & distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site. This eBook provides top tips on the best course of action to take, and provides summary recommendations for Sponsors on how to handle cold chain or temperature sensitive IMP across the supply chain, up until delivery to the investigator site.
A temperature excursion occurs when clinical trial material is stored at a temperature outside of the specified temperature range as defined on the label. This can have a substantial impact on a clinical trial study; it can impact the quality, efficacy and safety of products. More importantly, an excursion can significantly impact patient safety if not detected and communicated effectively.