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Case study

New Packaging Strategy Optimises Supplies and Prevents Break in Enrolment

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.

Recognising that this clinical trial needed help, the sponsor sought Almac Clinical Service’s supply chain expertise in forecasting, packaging, labelling, and distribution and the help of another vendor for Interactive Response Technology (IRT) support.

Almac’s team of experienced professionals worked with the sponsor and other key vendors under very tight time constraints to avoid disaster. Thanks to Almac’s intervention and support, the clinical trial was completed successfully; no patients were lost due to drug shortages. In fact supplies were sufficient to dose every patient on schedule, and no new patient randomisations were delayed.

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