Services: Medical Writing

Strong Medical Writing to Support Your Project

Services: Medical Writing

Synteract strives to deliver actionable results to address your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our team includes native speakers with years of experience translating all documents necessary for the performance of clinical studies.

Whether it’s a first clinical protocol, a pivotal trial protocol or associated documents such as the ICF, the investigator’s brochure, or a full IND/IDE, Synteract’s team brings the therapeutic, clinical, regulatory and writing expertise needed to ensure the success of your clinical trial from design phase to final regulatory submission.

We offer robust, reliable medical writing support to expedite submissions and approvals.

Synteract Medical Writing Services Include:

  • Protocol / informed consent development
  • Investigators brochure development
  • SOP development
  • IMP dossiers
  • Clinical study reports according to ICH E3 and eCTD format
  • Clinical study protocols and amendments 
  • Subject information sheets and consent forms, including local language ICFs (prepared and reviewed by the relevant country) 
  • Abstracts, manuscripts, and posters 
  • Regulatory applications and submissions
  • Case narratives  
  • Scientific publications for peer-reviewed journals 
  • Preperation and submission of NDA/sNDA , MAA, PMA, 510(k) 
  • Translations of regulatory documents

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