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Large Biotech Company Makes Cost Savings of $1.8 Million in Phase III Clinical Trial
Our client, a large biotech company, was planning a multinational, phase III clinical trial involving 800 patients to compare the efficacy, safety and tolerability of the Investigational Medicinal Products (IMP) with a comparator drug product for the treatment of Multiple Sclerosis.
To eliminate bias, the study was designed to be a randomised, double-blinded, placebo-controlled, parallel group equivalence trial, conducted in 17 countries involving 140 sites located in Western Europe, Russia, Ukraine, United States, Latin America and South Africa. Study participants were randomly assigned to receive IMP, comparator or a placebo for 9 months, followed by open label treatment for 15 months.
The sponsor company approached Almac to provide the following services throughout the duration of the study:
- Forecasting and Supply Chain Management Services
- Development of Master English Text Language (MELT) for Clinical Labels
- Global Comparator Sourcing
- Clinical Packaging, Clinical Distribution and Depot Services
Almac faced a number of challenges throughout this study when we looked at the comparator supply, IMP supply and placebo supply. The main priority for Almac’s Supply Chain Manager (SCM) was to ensure continuity of supply for patients already entered into the clinical trial and then to ensure IMP was available to support new patients at all stocking points in the global clinical supply chain.
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