Clinical Development

The Translational Medicine Group provides the project leadership required to design, initiate, conduct, and report clinical research that assists in understanding human illnesses, developing new therapies, and translating basic research findings into patient care. Our clinical development teams include Harvard faculty physicians, experienced scientists and seasoned project leaders with experience in both industry and academia.

Our Project Leaders build dedicated teams with expertise in disease specific therapeutic areas encompassing clinical trial methods, project planning and management, and facilitation. The knowledge base within our network ensures that studies have consistently high standards of scientific and medical representation that meet the regulatory requirements of the FDA and other competent authorities. We focus on the big picture when contributing to a clinical research project. We can develop a single protocol or an overall program plan. Our expertise ranges from determining the most effective protocol design to strategic planning and applying for clinical trial authorizations and INDs. We also have extensive experience in providing due diligence. From start-up to completion, our project managers communicate regularly and openly with clients and partners to ensure transparency.

  • First-in-Man clinical trials
    • Pharmacokinetics
    • Pharmacodynamics
  • Phase 1 clinical trials
    • SAD
    • MAD
  • Phase 2 clinical trials
    • Proof-of-Concept
    • Efficacy
    • ADME
    • Food effects
    • Drug-drug interactions
    • QTc
    • Special populations
  • Phase 3 clinical trials
    • Safety and Efficacy
    • Single, multicenter, national and international studies