Medical Writing

The Clinlogix medical writing team is comprised of experienced professionals who produce concise, substantive, and polished clinical documents that provide clarity and are scientifically accurate from protocol to package insert. Most of our medical writers are members of the American Medical Writers Association or the European Medical Writers Association.

Our global writing services range from the preparation of individual documents to extensive medical writing programs. Each Clinlogix medical writer assigned to a project team has the appropriate therapeutic expertise to deliver the highest quality written content. Furthermore, our medical writers work closely with biostatisticians, clinical research associates, project managers, and data managers to deliver accurate documents.

All writing documents undergo quality review and copy-editing to ensure they accurately interpret the study results, and comply with regulatory and stylistic guidelines.

Our Medical Writing team supports the preparation of the following documents:

  • Clinical Study Protocols
  • Informed Consent Forms including Patient Brochures
  • Periodic Safety Update Reports (PSURs)
  • Clinical Study Reports according to ICH-E3 or sponsor SOP
  • Clinical Investigation Reports according to ISO 14155
  • Clinical Study Report Appendices
  • Written and Tabular Summaries
  • Safety Narratives
  • Abstracts, Posters, and Journal articles