ISO 17100:2015  ·  ISO 9001:2015  ·  ISO 27001:2013

Medical Translation Services for Global Clinical Trials

An inaccurate translation within a global clinical trial can lead to patient safety risks, regulatory delays, and significant legal liability. Language Scientific is the first and only translation company featuring a dual-review process featuring certified linguists and Subject Matter Experts (SMEs) holding advanced degrees in medicine, science, or engineering.

Clinical Trial Language Solutions

Four dedicated specialties, where language is a clinical risk.

Linguistic Validation

ISPOR-aligned COA/PRO validation with clinician review, cognitive debriefing and submission-ready audit trails.

Endpoint Adjudication

Centralized, secure medical translations for CEC review. Efficient, fast turnaround times to meet key database locks.

Plain Language Summaries

Translate clinical trial results and scientific findings into clear, accurate language for patients and non-specialist audiences.

Clinical Helpline

A dedicated, 24/7/365 on-demand call center service designed to seamlessly integrate fully-customized support into your clinical trials.

AI Translation Guardrails: Keeping your trial on track

The fastest way for a clinical translation program to fail is unsecured data. Generic AI tools retain input, learn from it and expose it. Ours don’t. 

Language Scientific translations reside inside a controlled, ISO 27001-certified environment with zero-retention terms, NDAs with every subject matter expert on your project and secure encrypted file transfer end to end.

Zero retention

Your source and target content is not stored, mined or reused by any AI engine at any point.

ISO 27001 certified

Information security management certification alongside our ISO 17100 and ISO 9001 certified quality management system.

NDAs across the chain

Every linguist, reviewer and project manager touching your content is under strict, signed confidentiality agreements.

No public LLM training

Confidential trial data is never submitted to public generative AI tools or used to train external models.

HIPAA & GDPR protocols

Patient-identifiable data is handled under strict compliance controls, including redaction where required.

Audit-ready documentation

Certifications, security questionnaires and QMS documentation ready for your review

Built for clinical research managers

The four pillars of Language Scientific

99.7% On-Time Delivery

Clinical trial timelines are absolute. We guarantee on-time delivery for every project.

Full Transparency

Our LS Client Portal gives proactive access to project progress and documented quality checks.

Compliance-First Security

ISO 17100, 9001 and 27001 certified QMS, with strict HIPAA and GDPR-compliant protocols.

Global Regulatory Mastery

Deep knowledge of country-specific requirements to prevent trial slowdowns.

Expertise In

Clinical Research

At Language Scientific, we specialize in providing precise and culturally sensitive translations for Clinical Research Organizations (CROs). With over 25 years of experience, we ensure that your clinical trial documents are accurately translated to facilitate effective global research.
 

Our Clinical Research Translation Services Include:

  • Protocol Translations: Ensuring clinical trial protocols are clearly and accurately translated for international sites.
  • Informed Consent Forms: Translating consent documents to meet regulatory standards and patient comprehension.
  • Patient Questionnaires: Adapting patient-facing materials to be culturally appropriate and easily understood.
  • Pharmacological Studies: Providing precise translations of complex pharmacological data and studies.
  • Interactive Voice Response (IVR) Prompts: Localizing IVR systems to enhance patient engagement and data collection.
clinical research translation

Pharmaceutical

At Language Scientific, we understand the critical role that precise translation plays in the pharmaceutical industry. Our specialized services ensure that your pharmaceutical documents are accurately translated, facilitating seamless global operations and compliance with international regulations.

Our Pharmaceutical Translation Services Include:

  • Clinical Research Documentation: Accurate translation of clinical trial protocols, case report forms (CRFs), and informed consent forms to support multi-country trials.
  • Regulatory Submissions: Ensuring that all regulatory documents meet the stringent requirements of authorities such as the FDA, EMA, and PMDA.
  • Manufacturing and Packaging Materials: Translating manufacturing processes, batch records, and packaging inserts to maintain consistency and compliance across markets.
  • Patient-Facing Materials: Providing clear and culturally appropriate translations of patient information leaflets and educational materials to enhance patient understanding and safety.
pharmaceutical translation services

Medical Device

At Language Scientific, we specialize in delivering precise and culturally adapted translations for the medical device industry. Our expert team ensures that your documentation meets international regulatory standards, facilitating seamless global market entry and compliance.

Our Medical Device Translation Services Include:

  • Operating, Maintenance, and Installation Manuals: Providing clear and accurate translations to ensure proper device usage and maintenance.
  • Instructions for Use (IFUs): Translating user guides to meet regulatory requirements and enhance user comprehension.
  • Regulatory Compliance Documents: Assisting with translations for European Union and Asian market compliance, including MDR and IVDR requirements.
  • Software Application Interfaces and Documentation: Localizing software interfaces and accompanying documentation for global users.
  • Package Inserts and Labels: Ensuring that all labeling and packaging information is accurately translated to maintain compliance and user safety.
medical device translation services
 At Language Scientific, we offer comprehensive, industry-specific translation and localization solutions tailored to meet the unique needs of various sectors. Our expertise ensures precise global communication, enabling your business to effectively reach diverse markets.

Reasons to believe

For clinical research, pharmaceutical and medical device teams, translation is a must-do activity where the stakes involve patient safety and multi-million dollar regulatory hurdles. Our credibility rests on six pillars of certainty.

Guaranteed on-time delivery

A 99.7% on-time delivery rate guarantee keeps multi-national trial timelines intact and go-to-market dates uncompromised by language delays.

Medical-grade accuracy via SME dual review

Unlike generalist firms, every project pairs a certified linguist with an advanced-degree expert in your specific field of medicine, science or engineering.

Compliance-first security

ISO 17100 and ISO 9001 certified quality management system, with strict HIPAA and GDPR data protocols that integrate with your clinical management systems.

Full transparency via our Client Portal

We eliminate black-box vendor concerns, providing proactive access to project progress and documented quality checks 

Language Scientific certified stamp

Whether manual, AI-assisted or AI-generated, every translation is finalized with formal proof of medical-grade accuracy for regulatory bodies.

The ASKnetwork

Our Advanced Scientific Knowledge network supplies medical, scientific and technical experts across all major European, Asian, Middle Eastern, African and American languages.

Long-Term Relationships With

Real-World Successes

Ready to de-risk your global clinical trials?

Stop treating language as a downstream task. Join the life science leaders who use Language Scientific to scale safely.