Medical Writing

Biotrial takes pride in its dedicated team of Medical Writers, who collaborate with Clinical, Medical, Scientific and Regulatory experts to produce exceptional quality protocols, reports, and regulatory documentation for our sponsors.

Our Medical Writers have a solid scientific and clinic background, including PhD, MD, PharmD and MSc as well as an average of 10 years of experience in Medical Writing.

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Services

Our Medical Writing team assists sponsors in writing and preparing all necessary documents for clinical trials, preclinical projects, and regulatory submissions while ensuring all clinical trial deliverables are eCTD compliant.

  • Clinical Study Protocol / Investigation Plan
  • Clinical Study Report / Investigation Report
  • Development Safety Update Report (DSUR), periodic safety update report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER)
  • Lay summaries
  • Medical narrative
  • Clinical Study Report (CSR) anonymization
  • Investigator Brochures
  • CT.gov and EudraCT study registration and reporting
  • Scientific publications
  • QC of trial documents
  • Preclinical trial plans and reports

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