The clinical supply chain of investigational medicinal products (IMPs) is complex. The time from designing and packaging a kit through to it reaching the patient can take several months. Thus, management of the temperature exposure of a sensitive IMP is critical.
- Temperature deviations can put patients’ health and their participation in the study at risk.
- Following a temperature excursion, kits are quarantined until the viability is determined, which could result in their destruction if they are deemed unfit for use.
- An IMP supply chain where the temperature control is robust is therefore a vital asset.