The sponsor of a women’s health clinical trial had succeeded in enrolling just over half of its target number of patients when it foresaw a major problem: the existing drug supplies would be reaching their expiration date before new supplies would be available.
The sponsor had developed its own supply plan for the complex trial (which involved two patient cohorts and multiple treatment arms in each) and was following a block randomisation scheme. Decisions like this made early in the clinical trial plan, such as randomisation scheme and clinical packaging design, can have major implications on the success of a clinical trial, particularly if they leave little room to accommodate changing study conditions.
Recognizing that this clinical trial needed help, the sponsor sought Almac Clinical Service’s supply chain expertise in forecasting, packaging, labeling and distribution.
Download our case study by completing the form to learn how a new packaging strategy optimized the clinical supply for this clinical trial, completing successfully with no patients lost due to drug shortages.
If you require any further information, please contact Almac Clinical Services.