Mitigating Supply Chain Risks From Unpredictable Demand

Clinical trials have both predictable and unpredictable demand. Predictable demand accounts for known patients that are enrolled in the trial, have been assigned a Treatment Group, and have a defined visit schedule. Supply chain complexity is introduced primarily due to the unpredictable demand, which can stem from shifts in the expected enrollment rates as well as the ripple effect from protocol amendments throughout the study.

For example, patient enrollment can vary widely within regions, countries and sites due to competitive enrollment and other variables, such as discontinuation rate, titration probabilities, and patient physiology, all of which directly impact site demand and resupply strategies. Protocol amendments may add new treatment arms, extend the visit schedule, and/or add countries, all of which impact the supply chain.

This unpredictability introduces risk into the supply chain. It is critical for Clinical Supply Chain Managers to be aware of these risks and understand how best to mitigate them within their trials. Below, we highlight key areas of risk and how technology can help supply managers.