Clinical Trial TranslationBuilt for Compliance
Day Translations delivers audit-ready, regulatory-grade translations for CROs, pharmaceutical sponsors, and IRBs — from Informed Consent Forms to full NDA submissions — in 500+ languages.
Fully Accredited
Specialized Language Services for Every Clinical Stakeholder
Whether you are a global CRO managing 50 concurrent studies or a biotech sponsor preparing your first IND submission, Day Translations has the regulatory expertise and linguistic depth to support your program.
Built for the Operational Demands of Global CROs
Managing multi-site, multi-country studies demands translation partners who understand your workflows. Day Translations integrates directly with your clinical operations — providing centralized project management, dedicated linguist teams per therapeutic area, and Translation Memory (TM) systems that maintain terminology consistency across all sites and all amendments.
- Protocol & amendment translation with version control
- Site activation package localization
- eCOA / ePRO linguistic validation (ISPOR-aligned)
- Clinical Study Report (CSR) translation
- Regulatory submission support across FDA, EMA, PMDA
- 24/7 project management with dedicated CRO account teams
Comprehensive Clinical Trial Translation Services
Every document in a clinical trial carries regulatory weight. Our specialized services cover the complete lifecycle of your study — from first-in-human protocols to post-market surveillance reports.
Informed Consent Form (ICF) Translation
Certified ICF translations under FDA 21 CFR Part 50. Subject-matter expert linguists, independent review, and back-translation available, prepared to meet IRB submission requirements.
Clinical Trial Protocol Translation
Precise translation of study design, dosing regimens, eligibility criteria, and endpoints, handled by subject-matter expert linguists with relevant backgrounds in medicine and pharmacology.
Regulatory Submissions (IND, NDA, BLA, CTD)
Consistent terminology across thousands of pages using Translation Memory and custom glossaries. Prepared for FDA, EMA, PMDA, and Health Canada submissions.
Patient-Facing Materials
Patient diaries, PROs, recruitment ads, and questionnaires translated with clinical accuracy and plain-language accessibility for genuine participant comprehension.
Investigator Brochure (IB) Translation
Critical safety documents translated with precision: adverse event profiles, pharmacokinetics, and safety data communicated with full fidelity.
Case Report Forms (CRFs) & eCOA
Linguistic validation for eCOA translations including cognitive debriefing and harmonization, ensuring conceptual equivalence across all study languages.
Pharmacovigilance & Safety Reporting
DSURs, SUSARs, and PSURs translated rapidly and with zero ambiguity. Our 24/7 service helps safety signals reach regulatory authorities within required timeframes.
Linguistic Validation Services
Full ISPOR-aligned validation for COAs and PROs: forward translation, reconciliation, back-translation, cognitive debriefing, and final review.
Interpretation for Every Stage of Your Trial
Clinical communication does not stop at documents. Day Translations provides professional medical interpreters for the live moments of a trial, in 500+ languages.
24/7 availability for urgent and unscheduled needs.
Request an InterpreterResponsible AI for Regulated Trial Content
Speed matters in clinical trials, but regulated content carries no margin for error. Our approach keeps a qualified human expert in the loop at every stage.
Machine translation post-editing (MTPE) is available for lower-risk, high-volume material, and it is always refined by a specialist linguist. High-risk and patient-facing content, including informed consent forms, protocols, labeling, and safety reports, is translated by subject-matter expert linguists and reviewed under our ISO 17100 process. You choose the workflow, and we make sure the safeguards match the risk.
Informed Consent Form Translation Prepared for IRB Submission
Under FDA 21 CFR Part 50 and ICH E6(R3), participants must receive consent documents in a language they fully understand. Our ICF translations are completed by subject-matter expert translators, reviewed by a second independent linguist, and certified for IRB submission.
Every Translation Meets the Regulatory Standard That Matters
Clinical trial translations are regulatory artifacts subject to inspection by the FDA, EMA, and other health authorities. Day Translations applies one consistent set of certifications and compliance frameworks across all clinical work, so your translations are inspection-ready.
Certifications we hold
- ISO 17100:2015Translation quality, including independent revision by a second qualified linguist as standard on every ISO 17100 project.
- ISO 27001Information security management.
Compliance and regulatory alignment
- HIPAAProtected health information handling.
- GDPRData protection.
- 21 CFR Part 50Protection of human subjects (informed consent).
- 21 CFR Part 11Electronic records and signatures.
- ICH E6(R3)GCP-aligned clinical trial workflows.
- EMA CTREU Clinical Trials Regulation.
Status and memberships
- SOC 2 ReadyControls aligned to SOC 2. No SOC 2 certificate is issued; "ready" reflects control alignment.
- GSA Schedule contract holderApproved US government vendor.
- ATA MemberAmerican Translators Association.
- BBB A+ Rating
FDA regulations require that informed consent be provided in a language fully understandable to the subject. Day Translations helps ICFs meet this standard, with certified translations prepared for IRB submission.
The updated ICH E6(R3) GCP guidelines emphasize risk-based quality management and participant protection. Our workflows are designed to support these standards, with full audit trails and version control.
Day Translations is ISO 17100 certified, meaning every translation follows a rigorous two-step process: translation by a qualified linguist, followed by independent review by a second expert.
The EU Clinical Trials Regulation (EU No 536/2014) requires translations for participant-facing documents. Our European linguist teams work to EMA submission requirements.
All clinical trial documents contain protected health information. Day Translations maintains HIPAA-compliant handling with encrypted file transfer, secure storage, and strict access controls.
Our ISO 27001 certified information security management system protects clinical data, proprietary compounds, and patient information at every stage of the translation process.
A Validated 6-Step Translation Workflow
Every clinical trial translation follows a rigorous, documented process designed to meet regulatory inspection standards and ensure accuracy across all languages.
Project Intake & Scoping
Your dedicated project manager reviews document types, regulatory requirements, target languages, and timeline. A custom glossary and style guide are established or retrieved from your Translation Memory.
Linguist Assignment
Documents are assigned to subject-matter expert translators with verified credentials in your therapeutic area — oncology, rare disease, CNS, cardiovascular, or immunology.
Translation & Terminology Management
Translation proceeds using your approved glossary and Translation Memory. Every term is consistent with your previous submissions and aligned to regulatory terminology standards.
Independent Review & QA
A second independent linguist reviews the translation for accuracy, consistency, and regulatory compliance. Our QA team runs automated terminology checks and format validation.
Back-Translation (if required)
For ICFs and patient-facing materials, a third independent translator performs back-translation into English. Discrepancies are reconciled and documented for IRB submission.
Delivery & Certification
Final documents are delivered in your required format with a Certificate of Translation, audit trail, and version history — ready for IRB, FDA, EMA, or PMDA submission.
For Contract Research Organizations
Centralized translation management for multi-site, multi-country studies. Dedicated CRO account teams, integrated TM systems, and 24/7 project coverage that matches your clinical operations cadence.
For Pharmaceutical & Biotech Sponsors
Dedicated pharma translation teams with relevant backgrounds in pharmacology and regulatory affairs. Full IND-to-NDA lifecycle support with complete audit trails and version control per ICH E6(R3).
500+ Languages. Every Clinical Trial Region.
From Phase I first-in-human studies to global Phase III trials across 80+ countries, Day Translations provides native-language expertise in every major clinical trial market.
Every Document in Your Clinical Trial Program
The Clinical Translation Partner Trusted by Global Research Programs
With over 20 years of experience and more than 100,000 projects completed, Day Translations has built the processes, technology, and linguistic expertise to support demanding clinical trial programs — from single-country Phase I studies to global Phase III trials spanning 80+ countries.
Frequently Asked Questions
Everything you need to know about clinical trial translation services.
We align our workflows with ICH E6(R3) Good Clinical Practice, FDA requirements including 21 CFR Part 50 for informed consent and Part 11 for electronic records, the EU Clinical Trials Regulation, and ISO 17100 for translation quality.
Yes. For ICFs and patient-facing materials, an independent translator performs back-translation into the source language, and discrepancies are reconciled in a documented report prepared for IRB submission.
We use Translation Memory, custom glossaries, and centralized terminology governance, so terms stay consistent across every site, language, and amendment.
Yes. We offer expedited turnaround and 24/7 project management for urgent amendments, safety reports, and re-consent documents.
Linguistic validation confirms that a translated instrument such as a COA or PRO is conceptually equivalent and culturally appropriate. It follows an ISPOR-aligned process including forward translation, reconciliation, back-translation, and cognitive debriefing, and is commonly required for patient-reported outcome instruments.
We use encrypted file transfer, role-based access, secure storage, comprehensive NDAs, and BAA execution upon request, under an ISO 27001 information security management system.
Yes. We provide a Certificate of Translation on company letterhead, suitable for FDA, EMA, and IRB submissions.
We keep a qualified human expert in the loop at every stage. MTPE is offered for lower-risk, high-volume content and is always refined by a specialist linguist, while regulated and patient-facing content is translated and reviewed under our ISO 17100 process.
We support decentralized and hybrid trials with eCOA and ePRO linguistic validation, in-context review, and localization of digital trial interfaces.
Related Life Sciences Services
Clinical trials are one part of the life sciences spectrum. Day Translations supports the full drug development, device, and regulatory lifecycle.
Pharmaceutical & Biotech Translation
IND, NDA, BLA, CTD dossiers, drug labeling, and pharmacovigilance reports.
Linguistic Validation Services
ISPOR-aligned COA/PRO validation with back-translation and cognitive debriefing.
Drug Safety & Pharmacovigilance
DSURs, SUSARs, PSURs, and ICSRs translated 24/7 with zero ambiguity.
Regulatory Affairs Translation
CTD/eCTD dossiers, health authority correspondence, and risk management plans.
Genomics & Precision Medicine
NGS protocols, gene therapy filings, companion diagnostics, and biomarker studies.
Medical Devices Translation
510(k), PMA, CE Mark, EU MDR, IFU, and post-market surveillance documentation.
Ready to Advance Your Clinical Program?
Contact our clinical translation specialists today. We reply within 15 minutes during business hours, with 24/7 support for urgent requests.
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