Our medical writing team’s approach reflects our values of collaboration, efficiency, and integrity.

With expertise in early phase clinical trials and drug development, our medical writers deliver work that is clear, concise, regulatory compliant, and on time. 

CSR Addendum Documents

Safety Narratives

Electronic Publishing
(Granular eCTD or Legacy NeeS)

  • ADME
  • First in Human (SAD and MAD)
  • Bioavailability and Bioequivalence
  • Drug-Drug Interaction
  • Food Effect
  • Hepatic and Renal Impairment
  • Pharmacokinetics/ Pharmacodynamics
  • Immunogenicity and Biomarkers
  • Thorough QTc (TQT)
  • ADME
  • First in Human (SAD and MAD)
  • Bioavailability and Bioequivalence
  • Drug-Drug Interaction
  • Food Effect
  • Hepatic and Renal Impairment
  • Pharmacokinetics/Pharmacodynamics
  • Immunogenicity and Biomarkers
  • Thorough QTc (TQT)

Investigator Brochures

IND Support

Trial Registration and
Results Disclosure

Protocols and Protocol Amendments

Phase 1–3 Full and Synoptic Integrated Clinical Study Reports (CSRs) including:


Medical Writing Services

Comprehensive and comprehensible clinical documentation.

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