Clinical Development Plan Support

SITUATION

A biopharmaceutical company developing a revolutionary class of drugs using novel technologies was transitioning their lead compound from research to development and needed clinical leadership to drive program development, planning, and execution.

SOLUTION

  • Halloran implemented and assumed leadership of the clinical development team, prepared clinical plans and strategies, synopses and protocols, and authored sections of regulatory packages and filings.
  • Halloran managed the hiring of external clinical personnel and drove the Phase 1 Unit / Site Selection process to ensure that high-quality vendors were selected and that contracts were negotiated quickly and appropriately represented the sponsor.
  • Halloran provided insight and guidance regarding necessary infrastructure for a development company.
  • Halloran continues to provide all clinical operations leadership, successfully moving program development forward in alignment with company objectives.

VALUE

Halloran established a Phase 1 and overall clinical development plan for the company which met their needs and satisfied their expectations. Halloran continues to lead the company's Clinical Operations group and drive their clinical development activities.