Medical Translation
Medical translation is patient-safety work. Our linguists hold clinical or pharmaceutical credentials, work under signed BAAs, and follow ICH-GCP, ISO 17100, and ISPOR guidance for back-translation and linguistic validation. Every project ships through encrypted, access-controlled channels.
PHI scoped · Encrypted at rest · ICH-GCP aligned
ICF · es-419 · v6 of 6
Consentimiento Informado del Paciente
54
PRO items
37
Sites
12
Languages
Why this practice
Built for the bar that your matter sets.
Patient safety is the deliverable
A mistranslated dose, route, or contraindication is a clinical incident. Our QA assumes the worst case and double-checks anything that touches a clinician’s decision or a patient’s instructions.
Regulatory expectations, baked in
FDA, EMA, PMDA, and Health Canada do not accept generic translations. We format submissions, include translator declarations, and follow ICH-GCP and ISPOR for back-translation and reconciliation when you need them.
PHI handled like PHI
BAAs are signed before file access. Documents live in encrypted, access-controlled storage. Translator workstations are scoped, audited, and purged on your retention schedule.
What you get
Every packet, every time.
Each medical translation project ships as a complete deliverable — content, certification, and supporting evidence — packaged for the recipient who will actually open it.
Certificate of Accuracy
on letterhead · page 1 of 1
Authorized signature
Clinically credentialed linguists
MDs, RNs, PharmDs, and life-sciences PhDs in addition to professional translation credentials.
HIPAA workflow + BAA
Signed BAAs, scoped access, encrypted storage at rest, TLS in transit, audit trails on every file.
Back-translation + reconciliation
Independent back-translation and ISPOR-aligned reconciliation for regulatory and PRO instruments.
MedDRA / SNOMED terminology
Validated against MedDRA, SNOMED CT, ICD-10/11, LOINC, and your sponsor-specific glossaries.
Patient-safety review
Plain-language audit on patient-facing materials and IFUs — readability checked before sign-off.
FDA / EMA submission-ready
Formatted to FDA eCTD, EMA, and PMDA expectations; declarations and translator credentials included.
How it works
From intake to certified delivery.
Intake + BAA
BAA executed; PHI scoping confirmed; encrypted intake channel opened before any document moves.
Terminology lock
MedDRA, SNOMED, sponsor glossaries, and product names locked into a per-study terminology base.
Translation
Clinically credentialed linguist drafts; terminology enforced segment by segment.
QA + (optional) back-translation
Second linguist reviews against source; independent back-translation and ISPOR-aligned reconciliation when required.
Certified, encrypted delivery
Signed packet with translator declaration, delivered to your secure dashboard. Documents purged on your schedule.
Document types
Documents we routinely translate.
Compliance
Compliant by clinical standard
A documented HIPAA workflow, ISO 17100 two-linguist review, and ISPOR-aligned linguistic validation when sponsors require it.
HIPAA · BAA on file
ISO 17100
ICH-GCP-aware
ISPOR linguistic validation
FDA eCTD / EMA / PMDA formatting
EU MDR / IVDR labeling
- HIPAA · BAA on file
- ISO 17100
- ICH-GCP-aware
- ISPOR linguistic validation
- FDA eCTD / EMA / PMDA formatting
- EU MDR / IVDR labeling
FAQ
Answers to what customers ask most.
The ones we hear most often, answered by our dispatch and project-management teams.
Can't find it here?
01Are your medical translations HIPAA-compliant?
Yes. All medical projects follow HIPAA. Translators sign BAAs, files are encrypted in transit and at rest on US-based infrastructure, and access is scoped and audited.
02Can you translate clinical trial documents?
Yes. Protocols, investigator brochures, ICFs, CRFs, IRB packets, adverse-event narratives, and CSRs. We follow ICH-GCP and can deliver back-translation and ISPOR reconciliation on PRO instruments.
03Do you offer back-translation?
Yes. Independent back-translation and reconciliation are available for regulatory submissions and PRO/PROM instruments where independent verification is required.
04Can you handle medical device IFUs under EU MDR / IVDR?
Yes. We translate IFUs, UDI documentation, and labeling for EU MDR and IVDR scope, including all 24 EU official languages.
05What qualifications do your medical translators have?
Clinical credentials (MD, RN, PharmD) or life-sciences degrees, plus professional translation certifications. All are HIPAA-trained and BAA-bound.
Related translation services
More ways we can help.
Certified Translation
USCIS-accepted certified translations with a signed certificate of accuracy.
ExploreLegal Translation
Contracts, filings and evidence translated for court and counsel.
ExploreTechnical Translation
Manuals, specs and engineering docs with strict terminology control.
ExploreFinancial Translation
Statements, audits and filings translated with numeric precision.
ExploreStart a project
Get a medical translation back — within hours.
Upload your documents and receive an itemized quote in about an hour. Subject-matter linguists, a second-pair review, and a signed certificate of accuracy on every medical translation job.