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Clinical Trial Document Translation Services
- ISO 17100
- ITI
- CIOL
- UKVI Accepted
A multi-site international clinical trial depends on translation at every stage — protocols, informed consent forms, case report forms, adverse event reports. Each must be translated with precision to protect patient safety and maintain regulatory compliance.
Translation AZ provides certified clinical trial translation from our London office for CROs, pharmaceutical companies, biotech firms, and academic research institutions.
Documents We Translate
Clinical trial protocols
Objectives, design, methodology, and statistical considerations
Informed consent forms (ICFs)
Ensuring participants understand the trial, compliant with UK GDPR
Investigator brochures
Comprehensive summaries of clinical and non-clinical data
Case report forms (CRFs/eCRFs)
Data collection instruments requiring identical structure across languages
Patient-reported outcome measures (PROMs)
Validated questionnaires requiring linguistic validation
Clinical study reports (CSRs)
Methodology, results, and statistical analysis
Adverse event reports
Time-sensitive SAE reports and PSURs
REC/ethics committee submissions
Applications and correspondence with Research Ethics Committees
MHRA CTA supporting documents
Source documents supporting MHRA Clinical Trial Authorisation
Linguistic Validation and Back-Translation
For PROMs and COAs, simple translation is insufficient. We support the full linguistic validation workflow: forward translation, reconciliation, back-translation, clinician review, cognitive debriefing, and harmonization across all language versions.
ICH-GCP Compliance
ICH-GCP requires all participant information in a language they understand. We ensure compliance with ICH-GCP and 21 CFR Part 50, including accurate risk/benefit representation, consistent terminology, and version-controlled audit trails.
How It Works
Submit trial documents
Include therapeutic area, target languages, and trial phase.
Quote within 2 hours
We assess volume, complexity, and linguistic validation needs.
Translation and review
Specialist medical linguist. PROMs undergo full linguistic validation.
Certified delivery
Version-controlled and formatted for regulatory submission.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Running an International Clinical Trial?
Submit your trial documents for a free quote.
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Frequently Asked Questions
Yes. Independent back-translation as part of linguistic validation for PROMs, COAs, and ICFs.
Yes. Phase I through Phase IV, including pre-clinical and post-market surveillance.
Expedited turnaround for SAE reports. We confirm feasibility within 1 hour.
Yes. Oncology, cardiology, neurology, immunology, rare diseases, and gene/cell therapy.
MHRA Regulatory Submission Translation Services
- ISO 17100
- ITI
- CIOL
- UKVI Accepted
Every medicine and device seeking UK market approval must satisfy MHRA requirements. Since Brexit, the MHRA operates independently from the EMA, with its own pathways and evolving standards.
Translation AZ provides certified translation from our London office. Our translators know MHRA submission formats, eCTD structure, and UK-specific regulatory terminology.
Documents We Translate
Marketing Authorisation Applications
Clinical, non-clinical, and quality data for new medicines
Summary of Product Characteristics (SmPC)
The core document describing a medicine's properties and approved indications
Patient Information Leaflets (PILs)
Patient-facing leaflet in every medicine pack
MHRA safety reports
PSURs, risk management plans, safety variations
Pharmacovigilance documents
Adverse reaction reports, signal detection, benefit-risk assessments
Clinical Trial Authorisation documents
Applications for MHRA CTA authorisation
Variations and renewals
Type IA, IB, II variations and MA renewals
MHRA correspondence
Queries, responses, and regulatory advice letters
ILAP documentation
Innovation Passport, Target Development Profile, ILAP correspondence
Post-Brexit Regulatory Context
UK-specific terminology
MHRA terminology diverging from EMA conventions
GB marketing authorisations
Distinct from Northern Ireland Protocol arrangements
MHRA reliance pathways
Recognising other regulators' approvals with UK-specific documentation
Yellow Card pharmacovigilance
Reporting via Yellow Card rather than EudraVigilance
SmPC and PIL Translation
SmPCs and PILs require exact medical terminology, patient-accessible readability (PILs), MHRA-prescribed structure, and consistency across all product labelling.
How It Works
Submit regulatory documents
Include submission type and MHRA deadline.
Quote within 2 hours
Specialist regulatory linguist assigned.
Translation and review
MHRA regulatory specialist with independent review.
Certified delivery
Formatted for eCTD submission to MHRA.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Preparing an MHRA Submission?
Submit for a free quote. We respond within 2 hours.
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Frequently Asked Questions
Yes. With exact medical terminology and MHRA-compliant formatting.
Yes. UK-specific terminology and independent submission pathways.
Yes. PSURs, RMPs, adverse reaction reports, and benefit-risk assessments.
Yes. Formatted for MHRA eCTD module structure.
Pharmaceutical Labeling & Packaging Translation Services
- ISO 17100
- ITI
- CIOL
- UKVI Accepted
A mistranslated dosage instruction can cause harm. An omitted contraindication can put lives at risk. Pharmaceutical labeling translation is a matter of patient safety.
Translation AZ provides certified translation from our London office. Our translators understand MHRA labelling guidance, the Blue Guide, and character-space constraints.
Documents We Translate
Summary of Product Characteristics (SmPC)
The definitive document describing a medicine's approved properties
Patient Information Leaflets (PILs)
Patient-facing leaflet in every medicine pack
Patient package inserts
Information sheets included with dispensed medications
Primary container labels
Bottle, vial, syringe, blister labels with drug name, strength, lot, expiration
Secondary packaging (carton text)
Drug facts, storage instructions, NDC information
Blister pack text
Foil and card printing with limited character space
IMP labelling
Clinical trial medication labels compliant with Annex 13
Why Pharma Labeling Translation Is Different
Space constraints
Our DTP team manages text expansion/contraction to fit fixed label dimensions
Regulatory terminology
Standardized pharmaceutical terms, not colloquial equivalents
Typographical precision
Drug names, strengths, and units must be exact
Product consistency
Terminology consistent across USPI, medication guide, container, and carton
Quality Assurance Process
Translation by specialist pharmaceutical linguist
Independent review by second specialist
Dedicated numerical and dosage verification
DTP layout adaptation with typeset proofreading
Final QC check against source
How It Works
Submit labeling files
InDesign, PDF, Word, or XML with target languages and packaging specs.
Quote within 2 hours
Word count and DTP complexity assessed.
Translation, review, and DTP
Full pharmaceutical QA process.
Certified delivery
Print-ready PDF, InDesign, XML, or Word.
48–72 Hour Labeling Turnaround Rush available
Need Pharmaceutical Labeling Translated?
Submit your labeling files for a free quote.
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Frequently Asked Questions
Yes. Our DTP team adjusts font size, kerning, and layout to fit translations.
Yes. PDF, InDesign (IDML), and XML for packaging production.
Our translators follow 21 CFR Part 201 requirements.
Yes. Maintaining the FDA-prescribed format and terminology.
Medical Device Documentation Translation Services
- ISO 17100
- ITI
- CIOL
- UKVI Accepted
A mistranslated IFU can cause misuse. An inaccurate device label can lead to incorrect calibration. A poorly translated clinical evaluation report can delay clearance.
Translation AZ provides certified translation from our London office, combining medical terminology with technical precision for UKCA, CE marking, and MHRA requirements.
Documents We Translate
Instructions for Use (IFU)
Setup, operation, maintenance, cleaning, and sterilization
Device labeling
Labels including symbols per ISO 15223-1
510(k) submissions
Substantial equivalence analyses and performance data
Pharmacovigilance documents
Class III device clinical data and manufacturing documentation
Technical files
Design specs, risk analyses (ISO 14971), V&V reports
Clinical evaluation reports
Systematic assessments of clinical evidence
Post-market surveillance
Safety updates, adverse event analyses
User manuals
Comprehensive and abbreviated guides
Training materials
Clinical and technical training for HCPs
Service manuals
Documentation for biomedical engineers
Regulatory Framework
UKCA marking
UK Conformity Assessed for Great Britain market
CE marking
For EU and Northern Ireland under NI Protocol
UK MDR 2002
UK medical device regulations
EU MDR 2017/745
European MDR for EU and NI
MHRA device registration
Registration requirements for UK placement
How It Works
Submit device documentation
Include classification and target regulatory market.
Quote within 2 hours
Technical complexity assessed.
Translation and review
Specialist medical device linguist.
Certified delivery
DTP available for IFUs and labeling.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Medical Device Documentation Translated?
Submit for a free quote. We respond within 2 hours.
View credentials →
Frequently Asked Questions
Yes. Complete premarket notifications.
Yes. Including diagrams, callouts, and safety symbols.
Yes. Software UIs, help files, and IEC 62304 documentation.
Yes. Correct regulatory terminology for each market.
Patient Records & Medical Reports Translation Services
- ISO 17100
- ITI
- CIOL
- UKVI Accepted
When a patient relocates to the UK, their medical history travels in a language their new GP may not read. When UKVI requires medical evidence, the translation must be certified.
Translation AZ provides UK GDPR-compliant certified translation from our London office for NHS trusts, private hospitals, clinics, insurance companies, and immigration solicitors.
Documents We Translate
Hospital discharge summaries
Diagnosis, procedures, medications, and follow-up instructions
Pathology and lab reports
Histopathology, cytology, blood work, clinical lab results
Radiology reports
X-ray, CT, MRI, ultrasound, nuclear medicine imaging
Surgical reports
Operative notes, findings, post-operative instructions
Medical histories
Comprehensive patient histories and examination records
Referral letters
Physician-to-physician correspondence
Vaccination records
Immunization histories including CDC-schedule vaccines
Prescription records
Medication lists and pharmacy records
Mental health records
Psychiatric evaluations, psychological assessments
Dental records
Dental charts, treatment plans, radiographs
Medical certificates
Fitness-for-duty, disability assessments, life insurance medicals
Data Protection and Confidentiality
Data processing agreements with healthcare clients
Encrypted transmission and storage
Access restricted to assigned translator and reviewer
UK GDPR and Data Protection Act 2018 trained staff
Secure destruction of personal data upon completion
Common Use Cases
UKVI immigration — Vaccination records, TB certificates, and medical histories with UKVI-accepted certification.
NHS continuity of care — Records for patients registering with GPs and NHS consultants.
Insurance claims — Hospital records for private health insurance claims.
Medical negligence litigation — Translated records and expert opinions for court proceedings.
How It Works
Submit medical records
HIPAA-compliant upload. Include purpose.
Quote within 2 hours
Volume and complexity assessed.
Translation and review
Specialist medical linguist with clinical accuracy review.
Certified delivery
Via encrypted channels.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Medical Records Translated?
HIPAA-compliant handling guaranteed. Submit for a free quote.
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Frequently Asked Questions
Yes. BAAs, encrypted transmission, access controls, and HIPAA-trained staff.
Yes. Vaccination records and I-693 supporting documents with USCIS-accepted certification.
Cardiology, oncology, orthopedics, neurology, psychiatry, OB/GYN, pediatrics, emergency medicine.
Yes. Experienced with handwritten clinical notes from healthcare systems worldwide.
Informed Consent & Patient-Facing Materials Translation Services
- ISO 17100
- ITI
- CIOL
- UKVI Accepted
A patient who signs a consent form in a language they don’t fully understand has not truly given informed consent. Translated patient materials are a compliance requirement and a patient safety measure.
Translation AZ provides certified translation for NHS trusts, private hospitals, clinics, Research Ethics Committees (RECs), and healthcare communications agencies.
Documents We Translate
Surgical consent forms
Procedure descriptions, risks, benefits, and alternatives
Treatment consent forms
Consent for treatments, therapies, and diagnostics
Advance decisions
Advance decisions to refuse treatment, lasting powers of attorney for health
Advance directives
Living wills, healthcare proxies, DNR orders
Patient education brochures
Condition-specific guides and wellness information
Post-operative instructions
Discharge instructions, wound care, medication guides
Rehabilitation guides
PT/OT instructions and home exercise programs
Hospital signage
Multilingual navigation, safety, and patient rights signage
Patient portal content
Translated EHR patient portal content
Community health materials
Public health campaigns and disease prevention
Health Literacy and Cultural Adaptation
Reading level assessment
Targeting 6th–8th grade for general patient communications
Cultural sensitivity review
Adapting references and imagery for target communities
Plain language principles
Clear, direct language avoiding unnecessary jargon
Visual consistency
Translations work with original design elements
REC Compliance
For research consent forms, Research Ethics Committees require accurate translations. We provide certified translations, back-translations for REC review, and version-controlled documents.
How It Works
Submit materials
Include target population and reading level requirements.
Quote within 2 hours
Health literacy and cultural adaptation needs assessed.
Translation and review
Clinical accuracy and readability review.
Certified delivery
DTP available for brochures and signage.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Patient Materials Translated?
Submit for a free quote. We respond within 2 hours.
View credentials →
Frequently Asked Questions
Yes. Certified translations with back-translations and certificates for IRB files.
Yes. Targeting 6th–8th grade reading level for general patient communications.
Yes. Appointment reminders, lab results, medication instructions, messaging templates.
Yes. Ensuring translated versions match original visual design.
Healthcare Compliance & Policy Translation Services
- ISO 17100
- ITI
- CIOL
- UKVI Accepted
The CQC inspects and rates services. NHS trusts must meet NHS England standards. When providers serve multilingual workforces, compliance documentation must be accessible.
Translation AZ provides certified translation for NHS trusts, private hospitals, care homes, mental health providers, and community health services.
Documents We Translate
CQC compliance documentation
Policies supporting CQC inspection across the five key questions
NHS trust policies
Clinical governance, safeguarding, consent, and operational policies
CMS Conditions of Participation
Policy manuals for hospitals, SNFs, home health
Standard operating procedures
Clinical, administrative, and safety SOPs for multilingual staff
European MDR for EU and NI
QI plans, metrics, root cause analyses, patient safety reports
Infection control protocols
Isolation precautions, hand hygiene, PPE guidance, outbreak response
Staff training materials
Compliance training, orientation, competency assessments
Risk management documents
Incident reporting, liability assessments, risk mitigation
Credentialing documentation
Medical staff bylaws, credentialing applications, privileging
Patient rights and responsibilities
Patient bill of rights required by regulation
Safeguarding policies
Adult and children's safeguarding policies, procedures, training
Accessible Information Standard
Materials meeting the NHS Accessible Information Standard
NHS Accessible Information Standard
The NHS AIS requires health and social care organisations to identify and meet information needs of patients with disabilities. We translate patient-facing documents into community languages.
How It Works
Submit compliance documents
Policies, SOPs, or training materials.
Quote within 2 hours
Regulatory context and target languages assessed.
Translation and review
Specialist healthcare linguist with independent review.
Certified delivery
Formatted to match your policy templates.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Healthcare Compliance Documents Translated?
Submit for a free quote. We respond within 2 hours.
View credentials →
Frequently Asked Questions
Yes. Privacy, security, breach procedures, and staff training.
Yes. Accreditation policies, corrective actions, and survey preparation.
Yes. Vital documents including patient rights notices, consent forms, and complaint procedures.
Yes. Isolation precautions, hand hygiene, PPE, and outbreak response for multilingual staff.