Program Launch and Phase 1 Trial Management

SITUATION

An innovative biotechnology company that uses stem cell science needed regulatory and clinical operations guidance for launching their first Phase 1 Trial program.

SOLUTION

  • Halloran developed immediate and long-term regulatory strategy plans for product development.
  • Halloran facilitated product development discussions with the FDA and prepared all submissions on behalf of the client.
  • Halloran provided ongoing project management, monitoring, and vendor management for over two years.
  • Halloran revised CMC plans per strategy discussions and created a new CMC protocol and SOPs to adequately support the product goals.

VALUE

Company was able to successfully complete enrollment of the Phase 1 Trial and initiate a more expansive Phase 2 program.