ISO-Certified Medical Translation
for Clinical Trials

From protocols and ICFs to submission-ready documentation — managed by experienced clinical PMs. Trusted by global sponsors and CROs under NDA.

Dedicated PM

One point of contact

Version Control

Amendments tracked

Secure Setup

On-premise tools

Audit-Ready

Traceable workflows

Clinical Trial Documentation Expertise

Supporting regulated clinical trial documentation across all phases and therapeutic areas.

Clinical Research
  • Clinical Trial Protocols & Amendments
  • Informed Consent Forms (ICFs)
  • Investigator Brochures (IBs)
  • Clinical Study Reports (CSRs)
Patient-Facing Clinical Materials
  • Clinical Outcome Assessments (COA / eCOA)
  • Patient Information Leaflets & Sheets (PILs / PISs)
  • Patient-Facing Study Documents
  • Patient Questionnaires
Regulatory & Labeling
  • Instructions for Use (IFU)
  • SmPCs, Labels & Package Inserts
  • Regulatory Submissions & Correspondence
  • Safety & Pharmacovigilance Documentation

ISO-Aligned Clinical Translation Workflow

Designed for traceability, version control, and regulatory review.

Project Setup

Scope, timelines & risk assessment

Translation

Qualified medical linguists

Bilingual Editing

Medical accuracy & terminology control

QA & Validation

Linguistic QA & suitability checks

Delivery

Final verification

Support

Amendments & updates

Clients We Support

Client relationships protected by strict Non-Disclosure Agreements (NDAs).

Global Pharma
Leading CROs
Medtech Companies
Biotech Companies

Comprehensive Medical Documentation Services

Specialized linguistic services for regulated life science environments.

Core Medical Translation Services
  • Medical/Clinical Translation
  • Editing & Review
  • TEP (Translation + Editing + Proofreading)
Clinical Outcome Assessments (COA)
  • Translation of COA
  • Linguistic Validation (Translation Scope)
  • Back Translation
Linguistic Reconciliation & Review
  • Reconciliation of Multiple Versions
  • Linguistic Review
  • Terminology & Consistency Check
eCOA & Digital Clinical Content
  • eCOA Migration (Language Support)
  • Screenshot Review
  • Linguistic Testing (In-Context)
Quality Assurance & Compliance
  • QC (Quality Control)
  • LQA (Linguistic Quality Assurance)
  • Proofreading in Context
Documentation & Regulatory Support
  • Medical/Clinical Transcription
  • DTP & File Preparation (incl. OCR)
  • Notarization Support

Why Choose Us?

Project Management

Single point of contact with experienced clinical PMs.

Medical Expertise

Translations by qualified medical linguists with clinical domain expertise.

Audit Transparency

Traceable workflows with documented roles and linguist qualifications.

ISO-Aligned Quality

Controlled workflows aligned with ISO standards.

Enterprise Tech Stack (Non-Cloud)
Across memoQ SDL Trados Passolo XTM Phrase
Risk Mitigation & Security

Addressing clinical data risks through controlled infrastructure.

EU Data Hosting: Data stored in ISO-certified German centers, aligned with GDPR and HIPAA requirements.
Local CAT Tools: Non-cloud CAT environment using on-premise servers.
NDA Control: Legally enforceable NDAs for all personnel involved in projects.