Clinical Supply Chain Management – Large Biotech – Phase III Study

Large Biotech Saves $1.8 Million on Phase III Study

Our client, a large biotech company, was planning a multinational, phase III trial involving 800 patients to compare the efficacy, safety and tolerability of the 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
  • Comparator Procurement
  • Packaging, Distribution and Depot Service