Clinical Trial Medical Writing Services

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Expert Medical Writing for Clinical Trials

With strong scientific backgrounds and knowledge of GCP and ICH guidelines, our medical writers produce high quality, evidence-based scientific, technical, medical and regulatory documents for a broad variety of sponsors across all therapeutic areas.

Our custom approach allows us to use in-house or sponsor-supplied document templates. All the documents we produce undergo rigorous scientific, statistical, editorial and quality control reviews to ensure content, format, and style conformity in order to meet global technical and regulatory requirements.

Regulatory and Scientific Documentation

We can help you with:

  • Investigators’ Brochures (IB)
  • Investigational Medicinal Product Dossier (IMPD)
  • Synopsis / Protocol and Amendments
  • Informed Consent Form / Patient Information
  • Case Report Form / Patient Diary
  • Clinical Study Report in Line with ICH E3
  • Regulatory Briefing Documents / Briefing Packages
  • Laboratory Manuals
  • Pharmacy Manuals

Safety and Pharmacovigilance Writing

We support sponsors with the preparation of safety and pharmacovigilance documentation throughout the clinical development process, ensuring compliance with international regulatory requirements.

  • Vigilance Documents
  • Safety Reports
  • Narratives
  • Interim Reports
  • DSURs (Development Safety Update Reports)
  • RMPs (Risk Management Plans)

Publication and Scientific Communication Support

Our medical writers also assist sponsors in communicating clinical data to regulators, investigators, healthcare professionals and study participants through clear and scientifically accurate documentation.

Participation in :

  • Abstracts
  • Posters
  • Publications
  • Plain Language Summaries / Lay Language Documents
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Our laboratory

Eurofins Optimed SAS

1, rue des Essarts, 38610 Gières, France

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Supporting your clinical trials

Looking for a trusted partner to support your clinical trials? Let’s discuss how we can support your development programme.

Contact us 

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