When investigational medicinal products (IMPs) are exposed to conditions outside of their approved storage range, sponsors need to be ready to act or risk the integrity and success of clinical trials. Temperature excursion events not only have the potential to compromise the stability, efficacy and safety of the compromised IMP, they may distort clinical outcomes by undermining the reliability of trial data, increase risk to patients and trigger regulatory concerns via unreported or poorly documented excursions. The commercial and operational impacts associated with temperature control failures can be equally significant, with the potential to delay timelines, increase costs, and cause reputational damage. 

Considering the growing complexity of modern clinical trials and the sensitivity of many biologics and advanced therapies currently in the R&D pipeline, avoiding this domino effect requires effective mitigation and management. To keep patients safe and clinical trials on track, sponsors must implement a combination of proactive strategies to prevent temperature excursions from occurring during drug transportation and storage, and implement a robust, time-efficient process that enhances detectability throughout the entire clinical supply chain.