Day Translations
Life Sciences Translation

Life SciencesTranslation Services

Day Translations is the trusted language services partner for the global life sciences industry — from clinical trials and genomics to medical devices and regulatory affairs, in 500+ languages.

GDPR, AICPA SOC 2 Ready, HIPAA Compliant, ISO 17100 Certified, ISO 27001 Certified, ATA Member, BBB A+ Rating
500+
Languages
100K+
Projects
20+
Years
10,000+
Linguists
12
Verticals
IndustriesLife Sciences Translation

Trusted by Leading Life Sciences Organizations

💊
Top 20 Pharma
Global Sponsors
🔬
Global CROs
Contract Research
🩺
Medical Device Cos.
FDA & CE Mark
🧬
Biotech Startups
IND to NDA
🏥
Academic Med. Centers
IRB Studies
📋
Regulatory Agencies
Global Submissions
🧪
Diagnostics Cos.
IVD & IVDR

Serving 500+ life sciences organizations across 80+ countries. ISO 17100 · HIPAA · GCP-aligned workflows

Explore Life Sciences Translation by Category

Life sciences translation is not a single discipline. It spans clinical research, drug development, genomics, diagnostics, medical devices, and regulatory affairs, and each sector has distinct regulatory requirements, document types, and linguistic standards. Day Translations maintains dedicated specialist teams for each one. Select a category to learn more or request a quote for your specific needs.

Full Service Available

Clinical Trials

End-to-end translation for Phase I to IV clinical studies: informed consent forms, protocols, CRFs, investigator brochures, and regulatory submissions for FDA, EMA, PMDA, and Health Canada.

ICF / IRBGCP-aligned workflowsFDA · EMA

Pharmaceutical & Biotech

Full drug development lifecycle support: IND, NDA, BLA, and CTD dossiers, drug labeling, investigator brochures, and pharmacovigilance reports in 500+ languages.

IND / NDA / BLAPharmacovigilanceDrug Labeling

Genomics & Precision Medicine

Specialized translation for NGS protocols, gene therapy regulatory filings, companion diagnostics, biomarker study materials, and precision oncology trial documents.

NGS ProtocolsGene TherapyCompanion Dx

Medical Devices

Regulatory-grade translations for 510(k), PMA, CE Mark, and EU MDR submissions: IFUs, UDI labeling, clinical evaluation reports, and post-market surveillance documentation.

510(k) / PMACE Mark / MDRIFU

Diagnostics & Laboratory

IVD labeling, EU IVDR regulatory submissions, laboratory SOPs, assay development documentation, and ISO 13485 quality management documents for in vitro diagnostic manufacturers.

IVD / IVDRLab SOPsISO 13485

Regulatory Affairs

Regulatory submission support for FDA, EMA, PMDA, Health Canada, and ANVISA: CTD and eCTD dossiers, labeling, health authority correspondence, and risk management documentation.

CTD / eCTDHealth AuthorityRisk Management

Healthcare & Hospital

Patient records, discharge summaries, medical reports, and hospital communications translated with clinical accuracy and HIPAA-compliant handling for healthcare providers worldwide.

HIPAA CompliantPatient RecordsMedical Reports

Drug Safety & Pharmacovigilance

DSURs, SUSARs, PSURs, and individual case safety reports (ICSRs) translated with zero ambiguity. 24/7 availability helps safety signals reach regulatory authorities on time.

DSUR / PSURSUSAR24/7 Urgent

Linguistic Validation

Full ISPOR-aligned linguistic validation for COAs, PROs, and eCOAs: forward translation, reconciliation, back translation, cognitive debriefing, and final review.

ISPOR-alignedCOA / PROeCOA

Medical Education & Publishing

Medical textbooks, continuing medical education (CME) content, clinical guidelines, and scientific publications translated by subject-matter expert linguists with relevant medical backgrounds.

CME ContentClinical GuidelinesScientific Pubs

Biotechnology & Research

Research protocols, grant applications, laboratory notebooks, and scientific manuscripts translated for biotech companies, academic research centers, and government agencies.

Research ProtocolsGrant ApplicationsManuscripts

Global Regulatory Strategy

Multi-market regulatory translation programs with centralized terminology governance, translation memory systems, and dedicated regulatory linguist teams for global submissions.

Multi-MarketTM SystemsTerminology

End-to-End Clinical Trial Translation

From Phase I first-in-human studies to global Phase III trials, Day Translations provides audit-ready translations for every document in your clinical program. We assign subject-matter expert linguists with relevant backgrounds in medicine, pharmacology, and regulatory affairs, so your submissions meet FDA, EMA, ICH, and PMDA standards.

Informed Consent Forms (ICF)
Clinical Trial Protocols & Amendments
Investigator Brochures
Case Report Forms & eCOA
Regulatory Submissions (IND, NDA, BLA)
Pharmacovigilance Reports
Get a Quote for Clinical Trials
Clinical trial translation — Day Translations regulatory team
ISO 17100 Certified
Independent revision on every project

Responsible AI for Regulated Content

AI and machine translation can accelerate the right projects, but regulated life sciences 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 content such as internal documents and selected marketing material, and it is always refined by a specialist linguist. High-risk and regulated content, including informed consent forms, labeling, protocols, 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.

Human-in-the-loopMTPE where appropriateISO 17100 review

Every Translation Meets Regulatory Standards

One consistent set of certifications and compliance frameworks, applied across all of our life sciences work.

Certifications we hold

  • ISO 17100:2015
    Translation quality, including independent revision by a second qualified linguist as standard on every ISO 17100 project.
  • ISO 27001
    Information security management.

Compliance and regulatory alignment

  • HIPAA
    Protected health information handling.
  • GDPR
    Data protection.
  • 21 CFR Part 11
    Electronic records and signatures.
  • ICH E6(R3)
    GCP-aligned clinical trial workflows.
  • EMA CTR
    EU Clinical Trials Regulation.
  • EU MDR / IVDR
    Medical device and in vitro diagnostic submissions.

Status and memberships

  • SOC 2 Ready
    Controls aligned to SOC 2. No SOC 2 certificate is issued; "ready" reflects control alignment.
  • GSA Schedule contract holder
    Approved US government vendor.
  • ATA Member
    American Translators Association.
  • BBB A+ Rating

Medical Interpretation for Life Sciences

Translation is only part of clinical communication. Day Translations provides professional medical interpreters for the moments that happen in real time, in 500+ languages.

Over-the-phone interpretation (OPI) for patient calls and consultations
Video remote interpretation (VRI) for telehealth and remote site visits
On-site interpretation for investigator meetings, patient visits, and informed consent discussions
Interpretation for site audits, regulatory inspections, and ethics committee or IRB meetings
Conference and event interpretation for global research teams

24/7 availability for urgent and unscheduled needs.

Request an Interpreter

Linguistic Validation, Step by Step

For Clinical Outcome Assessments (COAs), including Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), and Observer-Reported Outcomes (ObsROs), we follow an ISPOR-aligned linguistic validation process so each instrument stays conceptually equivalent and culturally appropriate across languages.

1
Preparation
Define key concepts and review the source instrument, ideally with the instrument developer.
2
Forward translation
Two independent translators produce separate target-language versions.
3
Reconciliation
A linguist merges the two versions into a single reconciled translation.
4
Back translation
The reconciled version is translated back into the source language by independent translators.
5
Back-translation review
The back translation is compared against the original to catch any shift in meaning.
6
Harmonization
Versions are aligned across multiple languages for cross-country consistency.
7
Cognitive debriefing
The instrument is pilot-tested with target patients to confirm clarity and comprehension.
8
Review and finalization
Debriefing findings are incorporated, followed by proofreading and a certified final version with a validation report.
ISPOR-alignedeCOA migrationCOA / PRO / ClinRO / ObsRO

The Life Sciences Language Partner Trusted Globally

ISO 17100 Certified
Every translation is produced by a qualified linguist and independently reviewed by a second expert, as standard on every ISO 17100 project.
Regulatory Expertise
Our linguists bring relevant backgrounds in medicine, pharmacology, molecular biology, and regulatory affairs.
HIPAA & ISO 27001 Secure
Encrypted file transfer, role-based access, comprehensive NDAs, and BAA execution upon request.
24/7 Availability
Round-the-clock project management for urgent amendments, safety reports, and re-consent documents.
500+ Languages
Native-language experts in every major life sciences market, including FDA, EMA, PMDA, Health Canada, and ANVISA.
Dedicated Account Teams
Assigned project managers and linguist pools per sponsor and therapeutic area for consistent quality.

Frequently Asked Questions

Everything you need to know about life sciences translation services.

We support clinical research, pharmaceutical and biotech, genomics and precision medicine, medical devices, diagnostics and laboratory, regulatory affairs, healthcare and hospital communications, drug safety and pharmacovigilance, and medical education and publishing.

We assign linguists with relevant scientific backgrounds and use controlled terminology for NGS protocols, gene therapy filings, companion diagnostics, and precision oncology documents, with translation memory and glossary governance for consistency across a program.

Yes. We provide regulatory-grade translations for EU MDR and IVDR submissions, including IFUs, labeling, clinical evaluation reports, and post-market surveillance documentation, aligned to ISO 13485 documentation needs.

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 content is translated and reviewed under our ISO 17100 process.

Yes. We offer over-the-phone, video remote, and on-site medical interpretation for patient visits, investigator meetings, site audits, regulatory inspections, and ethics committee or IRB meetings, with 24/7 availability.

Fully Accredited

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Get Started

Ready to Advance Your Life Sciences Program?

Contact our life sciences specialists today. We reply within 15 minutes during business hours, with 24/7 support for urgent requests.

Reply within 15 minutes during business hoursHIPAA & ISO 27001500+ LanguagesISO 17100 Certified

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