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Penn Pharma

Drug Development, Clinical Supplies & Contract Manufacturing Solutions

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Clinical Trial Manufacture Case Study

CASE STUDIES
By Penn Pharma

Virtual Pharma Company

Client: Virtual Pharma Company

Challenge:

  • Problematic formulation and analytical method
  • Blinding issues with market leading comparator

Penn solution/ongoing support:

  • Developed a suitable manufacturing process and re-built the analytical method
  • Over-encapsulated market leading comparator and developed the analytical method to general appropriate stability data
  • Support for three simultaneous phase III trials
  • Average of 1,800 patients per trial
  • Multi national trial – EU, US and ROW
  • 64,000 monthly kits over two years
  • Bespoke child resistant – senior friendly (CRSF) packaging solution
  • Liaise with two CROs
  • Liaise with two IVRS providers
  • Penn arranged multiple global distribution depots