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.View Resource
Almac Clinical Services
Guided by our extensive clinical supply experience and expertise, Almac Clinical Services is recognised as an innovative, global solution provider within the specialised and complex market of clinical trial supply.
Our integrated and adaptable solutions offer the most flexible approach to support the delivery of global clinical trials from protocol right through to patient delivery.
Our core purpose is to be the partner of choice, to deliver the next generation of health care solutions effectively and to focus on winning for you and your patients.