Regulatory Documents
  • Briefing documents
  • Protocols/amendments (Phase 1-4, registries)
  • IBs
  • CSRs
  • IND
  • NDA
  • Narratives
  • Annual reports
Electronic Publishing Services (eCTD format)
  • Formatting Word documents
  • PDF rendering
  • Prepublishing (bookmarking, linking, etc.)
  • Electronic submission through ESG
Clinical Science
  • Develop or provide input on study-related documents such as CRFs, laboratory manuals, ICFs
  • Generate clinical content for publications, data review/safety meetings, decision-making taskforces, and Agency/IRB communications
  • Provide medical monitoring support, including review of protocol deviations, line listings, and medical coding, generation of queries, and hosting of regular medical monitoring meetings
  • Develop solutions (e.g., team site, trackers) to enhance medical monitoring efficiency and oversight of both patients and CRO activities
  • Serve as site and CRO point of contact for protocol-related questions
  • Develop clinical content for SIVs
Additional Services
  • Publications – manuscripts, abstracts, posters, white papers, publication plans
  • Literature searches/reviews
  • Narrative automation
  • Training
  • SOP/style guide writing
  • Redaction
  • Project management / content plan development