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