Supply chain agility in planning and execution is required to stay in step with clinical trial changes. Laurel Ferenchick, 4G Clinical's Senior Forecasting Services Lead, recently wrote an article for International Clinical Trials, discussing how trial complexity can lead to unexpected risks, and how to manage them within trials.
Here's a short excerpt.
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.
Laurel Ferenchick is a Senior Forecasting Services Lead at 4G Clinical. She has 15 years of experience in Clinical Supply Management and Forecasting, holding various positions in Packaging & Distribution Management, RTSM Build & Maintenance, and Clinical Supply Forecasting.