Program Management Services

The Translational Medicine Group strives to accelerate the translation of scientific discoveries into innovative diagnostics and therapies for disease prevention and improved health care delivery. Our developmental services enable accelerated and cost effective translation of discovery stage therapeutics into new medical solutions.

Our services include:

  • Program planning
    • Target Product Profile definition
    • Timeline, budget, and resources
  • Vendor management
    • Identification, qualification and negotiation
  • Clinical & nonclinical trials
    • Protocol design
    • Operational feasibility
    • Conduct
  • Preclinical and clinical trial conduct monitoring
    • GCP/ GLP compliance
    • Data management & review
  • Chemistry Manufacturing & Controls
  • Regulatory strategy & filings
    • Interaction with regulatory agencies (briefing packages, meeting attendance)
    • Generate summary documents
    • Prepare and manage eCTD & CTA submissions
  • Mechanistic study coordination
    • Sample collection and processing
    • Central pathology review