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Medical Writing

Veristat medical writers have expertise in a wide range of therapeutic areas. Medical writing services offered on a study-specific basis include production of clinical study protocols and amendments, and clinical study reports. Veristat also offers medical writing services to support clinical development programs as a whole, including preparation of pre-IND and IND documents, regulatory meeting briefing documents, and clinical sections of NDAs, including the CTD format.

Medical Writing services include:

• Investigational New Drug Applications (INDs), including Investigator Brochures
• Protocol creation and review
• Case report form review
• Clinical study reports (CSRs)
• Regulatory briefing documents (e.g., End-of-Phase 1, End-of-Phase 2, and Pre-NDA briefing documents)
• Integrated summaries of safety
• Clinical sections of Common Technical Documents (CTDs), including clinical summaries of safety (CSS), clinical summaries of efficacy (CSE)
• Safety narratives
• Annual reports (APRs)
• Abstracts for professional meetings
• Slide presentations for FDA Drug Advisory Committee and other regulatory meetings
• Manuscripts
• Report Publishing, including links and bookmarks