Medical Writing
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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
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.
