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.
HIPAA
BAA on file
ISO 17100
Two-linguist QA
ICH-GCP
+ ISPOR validation
PHI scoped · Encrypted at rest · ICH-GCP aligned
ICF · es-MX · 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.
HIPAA · BAA on file
A documented HIPAA workflow, ISO 17100 two-linguist review, and ISPOR-aligned linguistic validation when sponsors require it.
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.
Clinical care
- Medical records & charts
- Hospital discharge summaries
- Operative & pathology reports
- Lab & imaging reports
- Mental-health assessments
- Prescription labels & dosing
Clinical trials
- Study protocols
- Investigator brochures
- Informed consent forms (ICF)
- IRB / ethics packets
- Adverse event narratives
- Case report forms (CRF)
- Clinical study reports (CSR)
Regulatory & pharma
- FDA eCTD submissions
- EMA / PMDA submissions
- SmPC, PIL & labeling
- Pharmacovigilance reports
- Medical device IFUs (UDI / EU MDR / IVDR)
- Validation & QMS docs
Patient-facing & PRO
- Patient-reported outcomes (PRO / PROMs)
- Quality-of-life instruments
- Patient education & telehealth
- Public-health materials
- Discharge & after-visit summaries
- Insurance & EOB letters
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
Frequently Asked
Answers to what customers ask most.
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.
Ready when you are
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.
Upload + order
Send documents and confirm your order.
Specialist translation
Medical linguist translates and reviews.
Final delivery
Final files delivered digitally.