Client: Virtual Pharma Company

Challenge:

• Problematic formulation & 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 1800 patients per trial
• Multi national trial - EU, US & ROW
• 64,000 monthly kits over 2 years
• Bespoke Child Resistant - Senior Friendly (CRSF) packaging solution
• Liaise with two CROs
• Liaise with two IVRS providers
• Penn arranged multiple global distribution depots.