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Our medical writers work closely with Sponsors, Statisticians and Medical Advisers in order to develop study protocols, clinical investigation plans and study reports in accordance with current regulations and guidelines. The Medical Writers collaborate with the project team, and participate interactively throughout the study, from protocol to final study report.

Services

IRW offers medical writing as part of a full-service program or as a stand-alone service. Our medical writing team supports preparation of the following:

  • Protocol Design for Phase I-IV clinical studies and Post Marketing Observational Studies
  • Informed consent form design
  • Case Report Form Design
  • Study specific questionnaire design
  • Written and tabular summaries
  • Medical and scientific literature reviews
  • Literature Search
  • Periodic Safety Update reports (PSURs) and other pharmacovigilance documents
  • Expert reports and executive summaries
  • Data Safety Monitoring Board (DSMB) manuals
  • Interim/Final study report preparation
  • Clinical study reports
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