Services

Medical Writing and Editing

  • Primary/secondary manuscripts reporting results from clinical trials and post-marketing studies
  • Primary/secondary manuscripts reporting results from non-clinical studies (eg, observational)
  • Comprehensive narrative reviews
  • Systematic literature reviews
  • Congress abstracts, posters and slide presentations
  • AMCP-formatted dossiers
  • Health Technology Assessments (HTAs)
  • Formulary monographs
  • Formulary tools and flash cards
  • Prior authorization kits
  • Value propositions
  • Account management tools
  • Strategic account team slide decks
  • Speaker training
  • Advisory boards
  • Newsletters
  • Playbooks
  • Objection handlers

Regulatory Writing

  • Clinical study protocols
  • Clinical study reports (CSRs)
  • Clinical efficacy and safety overviews and summaries
  • FDA briefing documents
  • Pharmacokinetics (PK) reports
  • Investigators Brochures
  • Supporting documentation for labeling changes
  • Addenda to clinical overviews for license renewal