Do you provide a Certificate of Accuracy our IRB will accept?

Yes. Certified translations come with a signed Certificate of Accuracy on official letterhead, confirming the translation is complete and accurate and that the translator is competent to translate from the source language. Day’s certificate is suitable for FDA, EMA, and IRB submissions.

Should we translate the ICF before or after IRB approval?

After. If the IRB changes the English version, an earlier translation has to be redone and paid for at full length. The exception is the short form process under 21 CFR 50.27(b)(2), used when a participant who doesn’t speak English enrolls before a full translation exists.

Do you use machine translation on ICFs, labeling, or safety reports?

Not as the default. Those documents go to subject-matter linguists, and a second linguist revises each one. MTPE is reserved for lower-risk content, and you choose the workflow.

Are you ISO 13485 certified, and does it matter for device translation?

No. Day’s certifications are ISO 17100 and ISO/IEC 27001, not ISO 13485. ISO 13485 is the quality management standard for device manufacturers. What matters for translation is that the IFUs, labeling, clinical evaluation reports, and post-market surveillance files fit your ISO 13485 documentation and your EU MDR or IVDR submission.

How is life sciences translation priced?

Per project, once a project manager has reviewed the document type, word count, languages, file format, and deadline. Send the files with your target languages and deadline, and you get a scoped quote before work starts.

Life Sciences Translation Services

Q: How do you handle genomics and precision medicine content?

It goes to linguists with scientific backgrounds, working from controlled terminology for NGS protocols, gene therapy filings, companion diagnostics, and precision oncology documents. Translation memory and glossary governance keep those terms consistent across every study in the program.

Pharmaceutical sponsors, CROs, and medical device manufacturers use our life sciences translation services for informed consent forms, protocols, labeling, and safety reports. Subject-matter linguists translate each file, and a second linguist revises it under ISO 17100.

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ISO 17100:2015 certified
ISO/IEC 27001:2022 certified

Pharmaceutical, CRO, device, and diagnostics teams that have worked with Day Translations and Day Interpreting:

Common problems

Where Life Sciences Translation Slows a Program Down

Most translation problems in this industry aren’t about one bad sentence. They show up as a retranslated consent form, a term that changed between amendments, or a safety report stuck in a queue. Here’s where programs lose time, and what we do about it.

Consent Forms Translated Too Early

Sterling IRB advises sponsors to wait for IRB approval of the English ICF before translating. Even a minor change to the English version forces a full retranslation, because certification covers the whole document, so you pay for the entire ICF again.

How we handle it: Send us the approved version, and informed consent translation starts from final wording. When your IRB asks for a back translation, a third independent translator produces it, and every discrepancy is reconciled and documented for your submission.

Terms That Change Between Amendments

Protocol amendments, investigator brochure updates, and label changes keep coming for years. When each round goes to a different translator, the same adverse event ends up with two names, and a regulatory reviewer spots both.

How we handle it: Each sponsor gets a dedicated project manager and a linguist pool organized by therapeutic area. Your glossary and translation memory load before work starts, and once a sentence is approved, it’s reused in every later document, with version control on protocols and amendments.

Safety Reports on a Regulatory Clock

ICSRs, SUSARs, DSURs, and PSURs come with reporting deadlines that don’t move for a translation backlog.

How we handle it: Pharmacovigilance translation runs 24/7, so a case that lands on a weekend doesn’t wait for Monday. Our safety linguists work from MedDRA-aligned terminology databases in all major languages.

Raw Machine Output on Regulated Documents

AI-only translation looks cheap until something goes wrong. The 2026 Nimdzi 100 reports that buyers who used raw AI output on content previously judged “not for MT” saw “high-profile quality failures and hallucinations,” and went back to language providers for expert validation.

How we handle it: ICFs, labeling, protocols, and safety reports go to subject-matter linguists, with a second linguist revising each file. Machine translation post-editing is available for lower-risk content, and you decide where it applies.

Launches Across Many Markets

Under EU MDR, each Member State sets the language for device labels and instructions for use. A launch in a dozen countries means a dozen language requirements to meet on one schedule.

How we handle it: Our regulatory linguists work in dedicated regional teams covering North America, Europe, Japan, Asia-Pacific, and Latin America, on one centralized translation memory. Your IFU translation and EU MDR translation stay consistent in every market.

Why Day Translations

What Life Sciences Teams Get with Day Translations

Stacked regulatory binders, a desk globe and a row of national flags beside an open tabbed binder, submissions translated for health authorities in every market.

Life sciences specialists
Our pharmaceutical translators hold advanced degrees in pharmacology, medicine, biochemistry, or regulatory affairs, and clinical work is matched by therapeutic areas, including oncology, rare disease, CNS, cardiovascular, and immunology.
Submission-ready files
Each finished file comes with a Certificate of Accuracy, an audit trail, and a translation memory update. Pharmaceutical projects run on FDA 21 CFR Part 11 compliant audit trails.
One vendor for the portfolio
Clinical, regulatory, safety, device, diagnostics, and interpreting work sit with one team, under one set of security controls.
Security your procurement team can check
ISO/IEC 27001:2022 certification, SOC 2 Type II, a BAA for HIPAA-covered work, and a DPA for GDPR.

Our Specializations

Life Sciences Translation by Program

Clinical research, drug development, genomics, diagnostics, devices, and regulatory affairs each come with their own regulators, document sets, and terminology. We maintain dedicated specialist teams for each area, with subject-matter expertise matched to the content and regulatory requirements.

A clinical trial protocol and an informed consent form beside binders for case report forms and the investigator brochure, trial documents translated for every study site.

Clinical Trial Translation

Phase I to IV studies run by sponsors, CROs, and sites, with regulatory submissions for FDA, EMA, PMDA, and Health Canada.

A conference table with laptops, glass vials and blister packs as colleagues meet behind it, a multi-market submission program run on shared terminology.

Global Regulatory Strategy

Multi-market submission programs run on centralized terminology and translation memory, with dedicated regional regulatory linguist teams.

A technician in blue gloves lifting an amber vial from a rack on a lab bench, drug development whose IND, CTD and labeling documents we translate.

Pharmaceutical and Biotech Translation

Drug development from IND to NDA or BLA, including CTD dossiers and drug labeling.

A clinician pointing at a patient monitor beside an infusion pump and a coiled endoscope, medical devices whose IFUs and EU MDR files we translate.

Medical Device Translation

510(k), PMA, and CE Mark files, including EU MDR translation for IFUs and post-market reports.

Barcoded specimen tubes and a pipette filling a microplate beside a microscope, diagnostic lab work whose IVD documents and SOPs we translate.

Diagnostics and Laboratory Translation

IVD manufacturers working to EU IVDR, with quality documents prepared for ISO 13485 systems.

A hand beside a tablet of summary charts, a medicine carton and a blister strip on a desk, submission data translated for each health authority.

Regulatory Affairs Translation

Submission teams filing with FDA, EMA, PMDA, Health Canada, and ANVISA.

Hands checking a blister strip beside pill bottles and a laptop, the safety reports and case narratives we translate with consistent pharmacovigilance terms.

Drug Safety and Pharmacovigilance Translation

The same safety terminology in every periodic report and case narrative.

A clinician with a tablet sitting with a patient beside a blood pressure monitor and a pill organizer, a patient questionnaire validated for another language.

Linguistic Validation Services

Clinical outcome assessments that must measure the same concept in every country.

Sample tubes beside a monitor showing a DNA helix and binders labeled NGS Protocols and Gene Therapy, genomics filings and protocols we translate.

Genomics and Precision Medicine

NGS protocols, gene therapy filings, companion diagnostics, and precision oncology trials.

An anatomical heart model and a spine model beside an open medical atlas, the textbook and CME content we translate for medical publishers.

Medical Education and Publishing

Textbooks, CME content, clinical guidelines, and scientific papers for publishers and medical societies.

A benchtop glass bioreactor beside a petri dish, sample vials and a micropipette, the research protocols and manuscripts we translate for biotech teams.

Biotechnology Research

Protocols, grant applications, lab notebooks, and manuscripts from biotech companies, academic research centers, and government agencies.

Staff at a hospital nurses' station as a nurse in scrubs walks past, where patient records and discharge summaries need translating for patients.

Healthcare Translation

Hospital and patient communications, such as patient records and discharge summaries, sit with our healthcare translation team.

A scientist pipetting samples beside badges for ICH E6(R3) GCP alignment, 21 CFR Part 11 and EMA CTR, the frameworks our clinical document translation aligns to.

What We Translate

Documents We Translate from Protocol to Post-Market

Each stage of a program produces its own paperwork, and a protocol amendment needs different handling than a device label or a PSUR. Here’s what Day translates for sponsors, CROs, and device and diagnostics manufacturers, grouped by where each document ends up.

01
Clinical Trial and Patient-Facing Documents
- Protocols and amendments
- Informed consent forms and subject information sheets
- Investigator brochures
- Case report forms and eCOA content
02
Regulatory Submissions, Labeling, and Safety Reports
- IND, NDA, and BLA submissions in CTD and eCTD format
- Prescribing information, patient package inserts, and medication guides
- Summaries of product characteristics (SmPCs) and patient information leaflets
- Health authority correspondence and risk management documentation
- Individual case safety reports (ICSRs) and suspected unexpected serious adverse reaction reports (SUSARs)
- Development safety update reports (DSURs) and periodic safety update reports (PSURs)
03
Device and Diagnostics Documentation
- IFU translation for FDA, EU MDR, and global labeling requirements
- UDI labeling
- Clinical evaluation reports and post-market surveillance documentation
- IVD labeling, laboratory SOPs, and assay development records

AI & Human Expertise

Where Machine Translation Fits in Regulated Content

Machine translation post-editing (MTPE) means a machine produces the first draft and a specialist linguist corrects it. Day offers it for lower-risk, high-volume content, and a specialist refines every draft.

ContentWorkflow

Informed consent forms, labeling, protocols, and safety reportsTranslation by a subject-matter linguist, then revision by a second linguist

Internal documents and selected marketing materialMTPE, refined by a specialist linguist

You choose the workflow for each content type, and the safeguards match the risk. Day’s approach to medical AI translation keeps a qualified linguist in the loop at every stage.

Linguistic Validation

Linguistic Validation for COA and PRO Instruments

A translated questionnaire is only useful if patients in every country read the question the same way. Our linguistic validation follows an ISPOR-aligned process for patient-reported, clinician-reported, and observer-reported outcomes:

Instrument assessment
An LV specialist reviews the instrument, languages, regulatory requirements, and study timeline.
Forward translation
Two independent translators each produce a version, and an expert committee reconciles them.
Back translation
An independent translator translates the reconciled version back for comparison with the original.
Expert committee review
A multidisciplinary committee checks conceptual equivalence and produces the pre-final version.
Cognitive debriefing
We interview 5 to 10 target-language patients to assess comprehension and cultural fit.
Final version and dossier
Findings are worked in, and a complete LV dossier is prepared for FDA or EMA submission.

A scientist in a lab coat and blue gloves holding up a sample tube, the clinical research behind the COA and PRO instruments we validate.

For global trials, we harmonize versions across languages so scoring stays consistent, and the same process covers eCOA and ePRO versions.

Compliance & Certifications

Certifications We Hold and Frameworks We Align To

Procurement teams evaluating a life sciences translation company ask for two different things: the certificates a vendor holds, and the rules its workflows follow.

Certifications and Audits Day Holds

ISO 17100:2015
The international standard for translation services, including independent revision by a second qualified linguist on every project.
ISO/IEC 27001:2022
Information security management, audited every year by an accredited third-party body.
SOC 2 Type II
Independent validation of security, availability, and confidentiality controls. A SOC 2 audit produces a report, not a certificate.

Frameworks our workflows align to.

“Aligned” means the workflow follows the framework’s requirements. It doesn’t mean a certificate exists.

HIPAA
Handling of protected health information (PHI)
GDPR
Protection of personal data
21 CFR Part 11
Electronic records, with Part 11 compliant audit trails on pharmaceutical projects
ICH E6(R3)
Good clinical practice for clinical trial workflows
EU Clinical Trials Regulation
Clinical trial documentation for EU submissions
EU MDR and IVDR
Medical device and in vitro diagnostic submissions

Memberships and status

American Translators Association member, GSA Multiple Award Schedule contract holder, and BBB accredited with an A+ rating.

Project workflow

How a Life Sciences Translation Project Runs with Us

Every project moves through three stages: your team sends the files and context, our linguists translate and revise, and your reviewers sign off. Here’s what happens at each one.

New projectLife sciences
Informed consent formIRB-approved version
Target languagesSpanish · MXFrench · CAJapanese · JPGerman · DE
Glossary and TMAttached
ReviewersMRKLAS
Stage 1 · Your team
What Your Team Sends Us
- Source files, ideally the version your IRB, ethics committee, or authority has already approved
- Target languages and countries, plus any national requirements you already know
- Existing glossaries, translation memories, or earlier translations
- Your deadline, the names of your reviewers, and the format the submission needs
Translation jobISO 17100
- Scope and schedule
- Glossary and TM loaded
- Subject-matter translation
- Independent revision
- QA and formatting
Certificate of AccuracySigned by your project manager
Program teamTherapeutic area
- PMProject managerDedicated to your program
- TLLinguistPharmacology
- RVReviserRegulatory affairs
Stage 2 · Our linguists
What Our Linguists and Project Managers Do
1. Scope review: A project manager checks document type, languages, file format, and deadline, and confirms the price and schedule.
2. Terminology setup: We load your glossary and translation memory and set the controlled terminology for the program.
3. Translation: A subject-matter linguist with a background in medicine, pharmacology, molecular biology, or regulatory affairs translates the document.
4. Independent revision: A second qualified linguist revises it, as ISO 17100 requires.
5. Final checks and formatting: Our QA team runs automated terminology checks and format validation, and confirms the document is complete. Where needed, our DTP team matches the layout of the source file.
6. Certificate of Accuracy: Your project manager issues a signed Certificate of Accuracy with certified translations, for IRBs and authorities that ask for one.
Term reviewSpanish · MX
- informed consentconsentimiento informado
- adverse eventevento adverso
- washout periodperíodo de lavadoNew term
Saved to TMNext amendment
Stage 3 · Your reviewers
How Sponsor and In-Country Reviewers Sign Off
Our linguists flag new terms for your reviewers to approve as the translation runs. Once your reviewers approve a sentence, translation memory reuses it in every later document, so the next amendment starts from the agreed wording.
Each sponsor gets a dedicated project manager and a linguist pool organized by therapeutic area, which keeps the same people on the same program.

Send an IRB-approved ICF or a protocol amendment, and we’ll map out languages, reviewers, and dates. Request a Quote

Interpretation

Interpreting for Consent Discussions, Investigator Meetings, and Inspections

Some of the most sensitive moments in a trial happen out loud. Day Interpreting covers them in 500+ languages and regional dialects:

A medical interpreter speaking between a patient in a hospital gown and a clinician with a tablet, the consent discussions our interpreters cover.

Over-the-phone interpreting (OPI)

for patient calls and consultations

Video remote interpreting (VRI)

for telehealth visits

On-site interpreters

for patient visits and informed consent discussions

Conference interpreting, simultaneous or consecutive,

for multilingual meetings

On-demand access

through the DayInterpreting app

Over-the-phone interpreting (OPI)

for patient calls and consultations
Video remote interpreting (VRI)

for telehealth visits
On-site interpreters

for patient visits and informed consent discussions
Conference interpreting, simultaneous or consecutive,

for multilingual meetings
On-demand access

through the DayInterpreting app

Security

Security for Patient Data and Unpublished Trial Results

Trial files carry PHI, unpublished results, and dossiers months away from filing. These controls are documented in the Trust Center, where your security or procurement team can ask for the evidence:

AES-256 encryption at rest and TLS 1.3 in transit
Multi-factor authentication and role-based access
Region-specific data storage
NDA-bound linguists and staff
A Business Associate Agreement (BAA) for HIPAA-covered work and a Data Processing Agreement (DPA) for GDPR, on request
SOC 2 Type II audited controls for security, availability, and confidentiality

Results

Life Sciences Clients and Results

Day works with pharmaceutical sponsors, CROs, medical device and diagnostics manufacturers, biotech companies, academic research centers, and the review boards that oversee their studies. Our life sciences clients include:

Salus IRB:
An AAHRPP-accredited, non-profit independent IRB that reviews single-site, multi-site, and international research. Salus IRB is one of our largest life sciences translation clients.
AspenRx:
A pharmaceutical company that relies on Day Translations for its life sciences translation work.

Case Study: Salus IRB

Client: Salus IRB, an independent review board based in Texas, US

Relationship: Nearly five years, with 85 to 90 projects a month

The project: English to Spanish localization of about 46,000 words of clinical trial and pharmaceutical content
The hard part: The files carried embedded text as well as running copy, so every word had to be found and translated in place
What we did: Our linguists translated every word, including the embedded text, and our DTP team rebuilt 98 pages to match the original layout
The result: 98 formatted pages in Spanish, handled by the same team that manages Salus IRB’s monthly volume

For life sciences buyers and regulatory teams