Medical Writing & Publishing

Excelya>Capabilities>Medical Writing & Publishing

Excelya’s 30+ Medical Writers average over 10 years of experience to make sure your documents meet the highest quality standards in record time. We leverage that experience to produce documents at every stage of the clinical research protocol lifecycle, from development and submission to publication.

Located in France and Greece, our team of PhD and Master’s level writers have contributed to over 100 peer-reviewed papers in high impact journals.

Excelya's scope of action

What we deliver

Our Medical Writers can help prepare a wide range of clinical regulatory documents across the research lifecycle, from study initiation to publication.

Study development and submission:

  • Literature reviews
  • Study synopsis, protocols and protocol amendments
  • Investigator brochures
  • Case Report Forms
  • Informed consent forms (ICFs)
  • Pediatric Assent Forms
  • Educational material for patients, healthcare professionals and pharmaceutical personnel

Study documents:

  • Clinical Study Reports, including CSR synopses for public disclosure
  • Toxicology and Permitted Daily Exposure (PDE) report
  • Clinical Evaluation (CER) and Trend Report for medical devices
  • Temporary Use Authorization (ATU) reports
  • Registration of results in Clinical Trials database
  • EMA Policy 70 redactions
  • Clinical and non-clinical sections of the Common Technical Document (CTD), including overviews for EU and US Regulatory Authorities

Safety documents:

  • Patient safety narratives
  • Development Safety Update Reports (DSURs)
  • Periodic safety update reports (PSURs)

Publication documents:

  • Conference materials: abstracts, posters, slide set presentations
  • Papers for submission in peer-reviewed journals, including systematic reviews
  • Medical marketing reviews and reports
  • Product website content for scientific audience and patients

Documents are written according to ICH recommendations and reporting guidelines for health research.

Quality Control and Peer Review

Our objective: Zero Defects

Our three-pronged methodology for quality control leverages our peer review process:

  • Experienced staff: Our staff leverages an average of 10+ years of experience to avoid common pitfalls.
  • SOPs & Document Library: We use a library of templates and checklist for key documents as well as our comprehensive SOPs.
  • Senior Review: Documents are double- and triple-checked through our senior peers to ensure compliance with current guidelines and to eliminate individual errors.

Success case

In addition to the writing activities, I was asked to prepare the future regulatory submission in the context of the European Medicines Agency (EMA Policy/0070) guidance related to the publication of clinical data for medicinal products for human use.

This mission was very rewarding and required rapid adaptation with a deep dive into the regulatory environment and therapeutic area of the product