Clinical Trial Translation Services
Comprehensive translation of clinical trial documentation for global studies. Protocols, ICFs, CRFs, and patient materials across 150+ languages.
Supporting Global Clinical Development
Global clinical trials require accurate, consistent translation of critical documentation across all study sites. Our experienced team of medical translators and project managers ensures your clinical trial documents meet local regulatory requirements while maintaining consistency across all languages.
From Phase I through post-marketing studies, we provide end-to-end translation support with GCP-compliant workflows and rigorous multi-step quality assurance.
Whether you are coordinating a single-country study or a global program spanning dozens of sites, every translation is handled by linguists with therapeutic-area expertise, reviewed against approved terminology, and delivered with the documentation regulators and ethics committees expect.
Documents We Translate
Comprehensive translation support for all clinical trial documentation.
Protocol-Related Documents
- Clinical Trial Protocols
- Protocol Amendments
- Investigator Brochures (IBs)
- Case Report Forms (CRFs/eCRFs)
- Study Manuals
Patient-Facing Documents
- Informed Consent Forms (ICFs)
- Assent Forms (Pediatric)
- Patient Information Sheets
- Patient Diaries
- Recruitment Materials
Site Documentation
- Investigator Meeting Decks
- Site Initiation Materials
- E-Learning Modules
- Operations Manuals
- Training Certificates
Our Clinical Translation Process
A GCP-compliant workflow designed for accuracy, consistency, and speed.
Project Setup
Glossary development, style guide creation, and translation memory setup for your study.
Translation
Professional medical translators with therapeutic area expertise translate your documents.
Review
Independent medical review and quality assurance by a second qualified linguist.
Delivery
Formatted deliverables with translation certificates and comprehensive audit trail.
What You Receive
Every clinical trial project includes complete, submission-ready documentation.
Certified Translations
Signed certificates of accuracy for every translated document, accepted by regulators and ethics committees.
Back-Translation & Reconciliation
Independent back-translation with a reconciliation report documenting how each discrepancy was resolved.
Translation Memory & Glossary
Study-specific terminology assets that keep wording consistent across documents, sites, and amendments.
Audit Trail & Certificate
A complete audit trail and certificate of completion ready for inclusion in your trial master file.
Frequently Asked Questions
What is the typical turnaround time for ICF translation?
Standard turnaround for informed consent form translation is 5-7 business days per language. We offer expedited services with 24-48 hour turnaround for urgent needs.
Do you provide back translation for clinical trial documents?
Yes, we provide certified back translation services for all clinical trial documents when required by your sponsor or ethics committee.
How do you ensure consistency across multiple study amendments?
We maintain dedicated translation memories and glossaries for each study. All amendments reference the existing TM to ensure consistent terminology.
Can you handle urgent protocol amendments?
Yes, we have 24/7 project management support and can accommodate urgent protocol amendments with expedited turnaround.
Do you provide regulatory submission support?
Yes, we provide translation certificates and documentation suitable for regulatory submission to FDA, EMA, and other regulatory agencies.
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