End-to-End Language Services for Clinical Development
From linguistic validation of patient-reported outcomes to regulatory submissions and pharmacovigilance—comprehensive language solutions for the pharmaceutical, biotechnology, and medical device industries.
Linguistic Validation Services
ISPOR-compliant 9-step methodology for Clinical Outcome Assessments (COAs). Ensuring conceptual equivalence while maintaining psychometric properties across all target languages.
- PRO, ClinRO, ObsRO, PerfO instruments
- Forward & Back Translation
- Reconciliation & Harmonization
- Full audit trail documentation
Cognitive Debriefing Services
1,000+ trained moderators across 150+ languages. Patient interviews to assess comprehension and cultural appropriateness of translated instruments as required by FDA and EMA.
- In-Person, VRI & Telephone interviews
- Pediatric & Geriatric specialists
- Rare disease population expertise
- IRB/Ethics submission support
Clinician Review Services
300+ medical professionals across 25+ therapeutic areas providing expert clinical review of translated ClinRO instruments, protocols, and regulatory documents.
- Board-certified physicians (MDs, DOs)
- PharmDs & Specialist nurses
- Therapeutic area experts
- Psychologists & Psychiatrists
Clinical Trial Documentation
Complete translation of the full spectrum of clinical trial documentation to support global studies from Phase I through post-marketing.
- Protocols & Investigator Brochures
- Informed Consent Forms (ICFs)
- Case Report Forms (CRFs/eCRFs)
- Patient-facing materials
Regulatory Affairs Translation
CTD Modules 1-5, product labeling, and regulatory submissions for FDA, EMA, Health Canada, PMDA, NMPA and regulatory agencies worldwide.
- CTD Module 1-5 translation
- SmPC, PILs, IMP Labels
- NDS, ANDA, BLA submissions
- Variation & renewal dossiers
Pharmacovigilance Translation
Dedicated PV translation services with rapid turnaround and strict regulatory compliance for adverse event reporting and aggregate safety reports.
- ICSRs & SAE reports
- PSURs, DSURs, PBRERs
- Risk Management Plans
- 24/7 urgent support available
eCOA Migration Services
Electronic Clinical Outcome Assessment migration adapts paper-based instruments for electronic administration on tablets, smartphones, and IVRS systems.
- Platform UI string translation
- Screenshot review & certification
- Audio recording for IVRS
- Format & locale adaptation
Medical Device & IVD Translation
Specialized translation for EU MDR/IVDR compliance and global medical device markets including IFUs, labeling, and technical documentation.
- EU MDR/IVDR compliance
- Instructions for Use (IFUs)
- UDI labels & packaging
- Technical files & CERs
Our Life Sciences Clients
Trusted by pharmaceutical, biotech, and medical device companies worldwide
Therapeutic Areas
Deep expertise across 25+ therapeutic areas with specialized linguists and medical reviewers.
Regulatory Agencies Supported
Global regulatory expertise for your submissions worldwide.
Compliance & Certifications
Meeting the highest industry standards for quality and security.
Request a Quote
Tell us about your project and receive a detailed quote within 2 hours during business hours.
Contact us directly to discuss your life sciences translation project. Our team of specialists will provide a customized solution for your needs.
Or email us at lifesciences@cethos.com
Frequently Asked Questions
Common questions about our life sciences translation services.
What is linguistic validation?
Linguistic validation is the gold standard methodology for translating Clinical Outcome Assessments (COAs) used in clinical trials. It ensures conceptual equivalence across all target languages while maintaining the psychometric properties of the original instrument, following ISPOR guidelines. The process includes forward translation, reconciliation, back translation, back translation review, cognitive debriefing, and harmonization.
How many cognitive debriefing interviews are required?
ISPOR guidelines recommend 5-8 cognitive debriefing interviews per language to ensure adequate assessment of patient comprehension. For pediatric populations, cognitively impaired patients, or complex instruments, additional interviews may be recommended. Our team can advise on the optimal sample size for your specific project.
What regulatory agencies accept your translations?
Our translations are accepted by FDA, EMA, PMDA, NMPA, Health Canada, MHRA, Swissmedic, TGA, and other regulatory agencies worldwide. We maintain ISO 17100 compliance and follow GCP guidelines. All projects include complete audit trails and certification documentation.
Do you provide back translation services?
Yes, back translation is a standard part of our linguistic validation process. Back translations are performed by independent translators who have not seen the original source text, ensuring an unbiased review of conceptual equivalence. Back translation review meetings are conducted with the client to resolve any discrepancies.
What therapeutic areas do you cover?
We have specialized linguists and medical reviewers across 25+ therapeutic areas including oncology, CNS, cardiology, dermatology, endocrinology, gastroenterology, respiratory, rheumatology, ophthalmology, rare diseases, pediatrics, and psychiatry. Our team is matched to your specific therapeutic area for every project.
Start Your Clinical Translation Project
Partner with a team that understands clinical development. ISO 17100 compliant with specialized expertise across 25+ therapeutic areas.
ISO 17100 Compliant • ISPOR Guidelines • GCP Compliant • HIPAA Compliant