Medical and Scientific Writing
Everest medical writers have expertise in a wide range of therapeutic areas.
They hold post-graduate degrees and have proven capability in delivering full-service medical writing, editing, and electronic publishing of regulatory documents and scientific publications.
- Full service medical writing support for regulatory documents from clinical study protocols to regulatory submission documents.
- Clinical study protocols
- Investigator’s brochures
- Statistical reports
- Study reports (clinical and non-clinical)
- Subject narratives, IND safety reports, DSMB summaries/updates
- Integrated summaries of safety
- Integrated summaries of efficacy
- Clinical summaries of efficacy and safety for CTD/eCTD submissions
- Research proposals
- Document e-publishing, including rendering to PDF, creating bookmarks and hyperlinks, adding pagination, and processing scanned documents.
- Everest ICH E3 compliant template for CSRs or client-provided template can be used.
- Experience with Phase I-IV clinical efficacy/safety studies, pharmacokinetic and pharmacodynamic studies, retrospective observational studies, patient registries, health economics/outcomes research, and medical device studies.
- Scientific publication and meeting support, including manuscript development, abstracts, and preparation of slide materials for posters or presentations.