Over the past 15 to 20 years, the clinical supply landscape has experienced dramatic change. Clinical trials have increased in volume and have become more complex, decentralized, and patient-centric. Drug kits need to be closely monitor during their clinical supply so that deviations do not become a bottleneck to successful drug delivery.

This guide focuses primarily on the distribution and logistics phase of the clinical trial implementation where monitoring ambient conditions, mostly temperature and humidity data, becomes a crucial success factor for clinical trial supply.

Topics of this practical guide include information on:

• clinical trials (purpose, study phases, stakeholders, etc.)

• storage and distribution of clinical supplies

• temperature monitoring solutions

• outlook for the development of direct-to-patient shipments in clinical trials