Life Sciences Translation Services
End-to-end language solutions for pharma, biotech, and medical device companies. ISPOR-compliant linguistic validation, clinical trial translation, and regulatory submissions in 200+ languages.
Linguistic Validation
ISPOR-compliant linguistic validation of PRO, ClinRO, ObsRO, and PerfO instruments with forward/backward translation, harmonization, and cognitive debriefing.
- Forward & backward translation
- Reconciliation & harmonization
- Cognitive debriefing interviews
- Final proofreading & sign-off
Cognitive Debriefing
Patient interviews conducted by trained qualitative researchers to verify comprehension, cultural relevance, and conceptual equivalence of translated instruments.
- Trained qualitative interviewers
- Native-speaking patient panels
- Comprehensive debriefing reports
- Iterative revision support
Clinician Review
Independent clinician review of translated instruments by practicing healthcare professionals with therapeutic area expertise.
- Therapeutic area specialists
- Independent quality assessment
- Clinical accuracy verification
- Detailed review documentation
Clinical Trials Translation
Translation of clinical trial documentation including protocols, ICFs, CRFs, patient diaries, and study reports for global multi-site studies.
- Informed consent forms (ICFs)
- Case report forms (CRFs)
- Study protocols & amendments
- Patient-facing materials
Regulatory Affairs Translation
Certified translations for regulatory submissions including CTD modules, IND/NDA applications, drug labels, and SmPCs for global health authorities.
- CTD Module 1-5 translations
- Drug labeling & SmPCs
- IND/NDA submission packages
- Variation & renewal documents
Pharmacovigilance Translation
Fast-turnaround translation of adverse event reports, ICSRs, PSURs, and safety narratives with strict compliance to reporting timelines.
- Adverse event report translation
- ICSRs & safety narratives
- PSURs & risk management plans
- 24/7 expedited turnaround
eCOA Migration Services
Migration of validated paper COA instruments to electronic (eCOA) platforms with linguistic and screenshot review to ensure equivalence.
- Paper-to-electronic migration
- Screenshot review & sign-off
- Platform compatibility testing
- Linguistic equivalence checks
Medical Device Translation
Translation of IFUs, labeling, technical documentation, and clinical evaluation reports for medical device regulatory submissions worldwide.
- Instructions for Use (IFUs)
- Device labeling & packaging
- Technical file translations
- Clinical evaluation reports
What Our Clients Say
Therapeutic Areas We Cover
Our linguists have deep subject-matter expertise across a wide range of therapeutic areas and medical specialties.
Regulatory Agency Expertise
We prepare translations that meet the specific formatting, terminology, and compliance requirements of major global health authorities.
Compliance & Quality Standards
Every translation is produced in accordance with the industry's most demanding quality and regulatory frameworks.
Request a Life Sciences Quote
Get a customized quote for your life sciences translation project. We respond within 2 hours during business hours.
Contact our life sciences team for a customized quote. We'll scope your project, recommend the right service tier, and provide a detailed estimate—typically within 2 hours.
Or email us directly at lifesciences@cethos.com
Frequently Asked Questions
Common questions about our life sciences translation services.
What is linguistic validation and when is it required?
Linguistic validation is a rigorous, multi-step translation process required for patient-reported outcome (PRO) instruments used in clinical trials. It follows ISPOR guidelines and includes forward translation, reconciliation, back translation, harmonization, cognitive debriefing, and final review to ensure conceptual equivalence across languages.
How long does a typical life sciences translation project take?
Timelines vary by project scope. Standard document translations take 3-5 business days. Linguistic validation projects typically run 6-10 weeks per language depending on cognitive debriefing requirements. We offer expedited services for urgent regulatory submissions and pharmacovigilance reports.
Are your translators specialized in life sciences?
Yes. All life sciences translators hold advanced degrees in relevant fields (pharmacy, medicine, biology, chemistry) and have a minimum of 5 years of specialized translation experience. Many are practicing healthcare professionals or clinical researchers.
Which regulatory frameworks do you support?
We support submissions to all major regulatory bodies including FDA, EMA, Health Canada, MHRA, PMDA, NMPA, Swissmedic, and TGA. Our translations comply with ICH GCP, 21 CFR Part 11, EU MDR, and other applicable frameworks.
Do you provide certified translations for regulatory submissions?
Yes. We provide certified translations with declarations of accuracy for all regulatory submissions. Our process is ISO 17100-compliant, and we maintain full audit trails including translator qualifications, revision history, and quality assurance records.
Ready to Start Your Life Sciences Project?
Contact our specialized life sciences team for a consultation. We'll help you navigate regulatory requirements and deliver translations that meet the highest quality standards.
ISO 17100 certified. ISPOR-compliant methodology. FDA, EMA & Health Canada expertise.