Medical Writing

Ancillarie offers medical writing services to support clinical development programs as a whole, including preparation of Investigational New Drug (IND) applications, protocols, Investigator Brochures, regulatory meeting briefing documents, clinical sections of New Drug and Marketing Authorization Applications (NDAs and MAAs), as well as Module 2 components of the Common Technical Document (CTD).

Using in-house or sponsor-supplied document templates, we apply best practices for content, format, and style to meet global technical requirements.


 Protocol Development and Amendment

 Clinical Study Report

 Safety Narratives

 Integrated Summaries of Safety (ISS)

 Integrated Summaries of Efficacy(ISE)

 Clinical Section of Common Technical Document including Module 2.5 Clinical Overview, Module 2.7.3 Summary of Clinical Efficacy (SCE), and Module 2.7.4 Summary of Clinical Safety (SCS)

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