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Top Global CRO Advised by Almac’s Supply Chain Management Team
Our client, a top global Contract Research Organisation (CRO), approached Almac to provide Supply Chain Management (SCM) services which included forecasting and drug supply management for a small, pharmaceutical company based in Asia running three, phase II clinical trials.
Almac generated the bulk drug and packaged supply requirement forecasts to enable the sponsor to plan their manufacturing schedules and Almac to plan their production and clinical distribution needs.
There were a number of significant challenges to maintain and optimise the drug supply. Due to the sponsor’s limited production capacity there was limited Investigational Medicinal Products (IMP) available for study start-up. The IMPs was a combination drug with medical device. The use of the device was unclear. Almac and our client had to seek further clarification around the mechanics of the device.
The Almac SCM reviewed the client’s packaging designs in conjunction with the protocol and proposed a number of changes with the focus being on minimising the drug requirements. The new packaging design resulted in a 25% decrease in the quantity of syringes required.
After initial quantities had been packaged and released and 2 of the 3 studies had commenced recruiting, an issue was identified with the second delivery of IMP. Almac’s Qualified Person (QP) team worked continuously with the client for 3 weeks to resolve the issue.
The role of the SCM overseeing the study was critical as their knowledge of the clinical packaging and clinical distribution timelines enabled them to amend the proposed re-supply packaging quantities and prioritise the operations, to minimise the potential for drug shortages in the ongoing clinical trials.
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