Case studies

Manufacturing

Challenge - Research team identified an existing research grade compound to treat rare mitochondrial disorder but there was no GMP grade material available.

Solution - Identified suitable vendors to manufacture GMP grade product using appropriate methods and formulation. Set up agreements on behalf of sponsor and compiled CTA documentation specific to compound

Regulatory

Challenge - IMPD for a phase 1 study involving a biological product required to be completed within 1 month of initial draft but sponsor lacked resource and expertise.

Solution - Worked in collaboration with a regulatory consultant and the manufacturer, set up weekly meetings and successfully completed the IMPD for CTA submission before deadline

Training

Challenge - Sponsor identified a training need for two of their clinical trial units specific to IMP oversight

Solution - Delivered bespoke training to all clinical trial units covering IMP manufacturing, sourcing and management at site

Pharmacy resources

Challenge - Phase 1b study was struggling to open due to constraint in pharmacy resources and funding was about to be terminated

Solution - In collaboration with the manufacturer and pharmacy staff, provided flexibility to sites with regards to IMP preparation to allow nurses to prepare IMP at bedside. Trial opened after the necessary training provided to nurses and other HCPs for IMP preparation