A large pharmaceutical sponsor needed support for a Phase III program in Type II diabetes conducted in multiple European countries.   This was a highly competitive therapeutic area, involving significant patient numbers across a high number of countries.  In addition, the study solid oral comparator had to be blinded and the large number of subjects involved meant that the comparator processing costs to support that volume would be high.

Our procurement and engineering teams defined sourcing options and conducted feasibility assessments to ensure the selected comparator formulation could be over encapsulated via an automated high speed process. In parallel, comparative dissolution work was conducted by our analytical laboratories to ensure equivalency of the blinded comparator.  Once established, the blinded product was put on stability using validated methods developed by the analytical team for the comparator.

By applying innovative engineering and analytical solutions to a challenging supply chain situation, supplies production was able to track increasing demand of recruitment while ensuring a cost effective solution. Leveraging significant experience in comparator method development and analysis, initiation of stability studies for the manipulated product was kept off the critical path and delivered without additional project management or technical support from the sponsor.