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.

  1. 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

  2. Document e-publishing, including rendering to PDF, creating bookmarks and hyperlinks, adding pagination, and processing scanned documents.

  3. Everest ICH E3 compliant template for CSRs or client-provided template can be used.

  4. 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.

  5. Scientific publication and meeting support, including manuscript development, abstracts, and preparation of slide materials for posters or presentations.

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