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Guiding Pre-trial Decisions to Ensure Sponsor Plans First Phase III Study With Confidence
When creating a clinical supply plan, it is often necessary to investigate a broad spectrum of considerations when attempting to answer a single enquiry.
That was the experience when one sponsor came to Almac Clinical Services with a seemingly simple question: How much Active Pharmaceutical Ingredient (API) do we need to have manufactured for our phase III clinical trial?
The sponsor, a small, fully outsourced company, was planning two simultaneous phase III studies with a novel drug for the treatment of a highly infectious disease. The company contracted a manufacturer to produce the API, but didn’t know how much to order, nor how much to budget for it. As is often the case, uncertainty around enrolment rates in the early stages of planning a clinical trial made the forecasting of bulk demand and other upstream activities very difficult.
In order to answer the sponsor’s initial question about API quantities, Almac’s Supply Chain Managers (SCM) needed to understand more about the product’s stability program, and preliminary thoughts around country participation and roll out.
Although the sponsor thought that its initial request (to estimate API quantities) was self-contained, Almac’s supply chain experts recognised that rarely can anything in a clinical trial be considered in isolation. The team pursued a line of questioning with the sponsor that ultimately led to a much more strategic approach to the trial. By working with Almac from the very early stages, the sponsor was able to avoid pitfalls that could have resulted in product wastage and trial delays.
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