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.