Medical Writing

Regulatory documents require a strong scientific and technical expertise to correctly summarize the necessary data collected in the course of developing and bringing new drug to the market. Errors in Medical Writing can cause significant delay in the Project.

At OSSINC , we strive to deliver actionable results to address the clinical trial needs.

Our medical writing group consist of qualified Medical Writer and certified experts with experience in a wide range of indications & therapeutic areas, study designs, and medical writing deliverables, as well as a proven publication track-record.

Our services include:

  • Protocol development
  • Informed consent development
  • Integrated clinical statistics reports
  • Investigator's brochure development
  • SOP development
  • IMP dossiers
  • Clinical study reports
  • Clinical study protocols and amendments
  • Subject information sheets and consent forms, including local language ICFs
  • Abstracts, manuscripts, and posters
  • Regulatory applications and submissions
  • Case narratives
  • Scientific publications for peer-reviewed journals
  • IND summary sections and special reports
  • Pre- and post-approval aggregate safety reports
  • Serious adverse event narratives
  • Human pharmacokinetics and bioavailability
  • Translations of regulatory documents