Medical Writing

Medical Writing Services at bioskin

bioskin provides Medical Writing that is clear, comprehensive, carefully focused and precise.  The documents are standards-compliant and can be quickly and easily read and understood by scientific, medical and regulatory professionals.

Medical Writing services are offered as stand-alone services for dermatological and other therapeutic areas as well as part of full packages and include:

  • Clinical trial protocols, clinical investigation plans
  • Subject information leaflets, diaries
  • Clinical Study Reports (CSRs) according to ICH-E3 for single- and multi-center trials
  • Preparation of appendices for CSRs
  • Linking and bookmarking processes
  • CSRs in Common Technical Document (CTD) or electronic Common Technical Document (eCTD) for application dossier
  • Clinical investigation reports (CIRs) according to ISO 14155
  • Lay language summaries
  • Scientific publications (journal articles, abstracts, posters)
  • Editing and review of documents assuring that documents comply with regulatory, journal, or other guidelines in terms of content, format and structure
  • Regulatory documentation (IND, briefing packages, etc.)

All services can be offered according to bioskin or sponsor SOPs.