FARMOVS (PTY) LTD

Medical Writing

Medical Writing

Our team of regulatory medical writers draws on many years of experience in the development of a variety of clinical study documents. These documents are created following global, regional, and country-specific guidelines, tailored to client needs. The team makes use of either FARMOVS document templates or client templates, as preferred by the client and/or as required by the research. FARMOVS subject matter experts or external consultants provide input and advice as required. Quality control forms an integral part of the document development process to ensure only the highest quality deliverables. Translation of documents to local language(s) is performed in-house by mother-tongue speakers of the target language or is outsourced to external, qualified translation services.

Our Medical Writing Services Include:

• Clinical study protocols and amendments (Phase I–III) according to ICH E6
• Clinical study reports (Phase I–III) (integrated, full, abbreviated, synoptic and addenda) according to ICH E3 and in eCTD format
• Subject information sheets and informed consent forms (such as main, serology, genetic, biobanking for future research)
• Subject directed documents (including pamphlets, questionnaires, and subject diaries)
• Adverse events and case narratives
• Investigator’s brochures
• Articles and abstracts for scientific publication
• Translation of documents