Our consultants are experts in clinical development strategy and regulatory document preparation. Having guided clinical development and written numerous INDs and NDAs and BLAs, our clinical consultants can provide:

Clinical Strategy:

  • Develop key messaging for INDs, NDAs, BLAs and MAAs
  • Develop optimized clinical development plans

Medical Writing:

  • Develop and Write Protocols
  • Develop and Write Protocol Synopses
  • Write Clinical Study Reports (CSR)
    • Phase 1-3 including post-approval Phase 4 studies, if required
  • Write and Review Clinical CTD modules including;
    • Modules 2.5 and 2.7.1 through 2.7.6
    • Integrated Summary of Efficacy (ISE)
    • Integrated Summary of Safety (ISS)
    • Risk/Benefit Statements
  • Review Statistical Analysis Plans


  • GCP compliance expertise