Medical Translation Services for Healthcare & Life Sciences
If you don’t have a medical background, you probably can’t. Yet medical translation is, fundamentally, specialized paraphrasing. These surgical instructions require a translator who understands orthopedic anatomy, surgical techniques, and clinical terminology at a professional level. Would you want your surgical instructions translated by someone without an MD?
At Language Scientific, we hold to a fundamental principle: “If You Don’t Understand It, You Cannot Translate It!”
That’s why all our medical translators and editors have relevant education, training, and work experience matching the subject matter they translate. Many hold MDs, PharmDs, or PhDs in medical sciences. Whether translating patient case report forms for FDA submission or packaging for in-vitro devices to comply with the EU’s IVDR directive, there can be no compromise where language and healthcare regulation converge.
Our ISO 9001:2015 and ISO 17100:2015 certified quality management system serves pharmaceutical companies, clinical research organizations (CROs), medical device manufacturers, biotech companies, and healthcare providers across four critical industry verticals: Clinical Research, Pharmaceutical, Medical Device, and Pharmacy. We deliver precise, contextually relevant translations in 215+ global languages, supporting clinical trials, patient communication, and regulatory compliance worldwide.
Clinical Research Translation Services
Global clinical trials demand absolute precision in multilingual documentation. A mistranslated informed consent form can invalidate patient enrollment. An ambiguous protocol translation can lead to protocol deviations at international sites. Inconsistent adverse event terminology can compromise safety reporting. Language Scientific understands these stakes.
Essential Clinical Research Documents We Translate
Our clinical research translation services cover the complete clinical trial documentation lifecycle:
Clinical Trial Protocols: Study design, methodology, endpoints, inclusion/exclusion criteria, and statistical approaches requiring scientific precision and consistency across all sites.
Informed Consent Forms (ICFs): Patient-facing documents requiring not just accurate translation but cultural adaptation and appropriate readability levels (typically 8th grade in the U.S., varying by country) to ensure true informed consent.
Case Report Forms (CRFs): Data collection instruments demanding identical medical terminology across all language versions to ensure data comparability and regulatory acceptance.
Patient-Reported Outcomes (PROs) and Questionnaires: Clinical instruments requiring linguistic validation—a specialized process beyond simple translation that includes cultural adaptation, cognitive debriefing, and harmonization across languages to ensure validity across international sites.
Investigator Brochures: Comprehensive drug information for clinical investigators, requiring scientific accuracy while maintaining readability for medical professionals in each target country.
Regulatory Submissions: IND/CTA documentation, ethics committee submissions, clinical study reports, and safety documentation (Development Safety Update Reports, Suspected Unexpected Serious Adverse Reactions).
Study Reports and Site Documentation: Final study reports, monitoring reports, training materials, and site initiation documentation supporting global trial operations.
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Linguistic Validation of Patient-Reported Outcomes
Language Scientific has provided linguistic validation of PRO questionnaires and clinical instruments for over 10 years, with experience in 70+ languages. PRO questionnaires are critical tools for gathering valuable insight into symptoms, side effects, and safety of investigational drugs. However, their validity across international sites requires not just translation and cultural adaptation, but formal linguistic validation and harmonization across languages and locales.
Our validation process ensures that translated instruments maintain the same measurement properties as the original, enabling reliable cross-cultural data comparison essential for global clinical trials.
Global Clinical Trial Language Coverage
Increasing globalization of clinical research means trials now span dozens of countries across diverse linguistic regions. While most clinical trial translation involves major languages—Chinese, Dutch, French, German, Hebrew, Italian, Japanese, Korean, Portuguese, Russian, and Spanish—Language Scientific offers 215+ global languages to support trials in emerging markets and rare disease studies requiring specialized patient populations.
Pharmaceutical Translation Services
Pharmaceutical translation extends from drug discovery through commercialization, requiring a deep understanding of regulatory frameworks, pharmacological terminology, and global compliance requirements. At Language Scientific, we ensure your pharmaceutical documents facilitate seamless global operations and compliance with international regulations.
Pharmaceutical Documentation We Translate
Regulatory Submissions: INDs, NDAs, BLAs, MAAs, DMFs, annual reports, and complete submission dossiers formatted to meet jurisdiction-specific requirements.
Pharmacovigilance Documents: Safety Data Sheets (SDS), Development Safety Update Reports (DSURs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and periodic safety update reports requiring rapid, accurate translation for regulatory timelines.
Drug Labeling and Patient Materials: Package inserts, prescribing information, medication guides, and patient education materials requiring both technical accuracy and patient-comprehensible language.
Manufacturing Documentation: Batch records, standard operating procedures (SOPs), validation protocols, and quality control documentation supporting GMP compliance.
Pharmacological Studies: Preclinical and clinical pharmacology reports, toxicology studies, and pharmacokinetic/pharmacodynamic analyses.
Marketing and Commercial Materials: Product brochures, sales training materials, promotional content, and patient support program materials.
Regulatory Compliance Across Global Markets
Pharmaceutical translations must comply with stringent regulatory requirements, especially for FDA (United States), EMA (European Union), and PMDA (Japan). Language Scientific understands regional regulatory differences, terminology preferences by regulatory body, and jurisdiction-specific submission format requirements. We provide certified translations with documentation meeting regulatory submission standards and audit requirements.
Medical Device Translation Services
Medical and surgical device manufacturers face unique translation challenges—complex technical documentation, stringent international regulatory standards, and the critical need for precise instructions that ensure patient and provider safety. Language Scientific specializes in delivering precise and culturally adapted translations that meet international regulatory standards, facilitating seamless global market entry and compliance.
Medical Device Documents We Translate
Instructions for Use (IFU): Critical patient and healthcare provider instructions requiring both technical precision and clarity. IFUs must accurately convey device operation, contraindications, warnings, and troubleshooting while remaining comprehensible to end users.
Regulatory Submissions: 510(k) applications, CE marking documentation, technical files for EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) compliance, and submissions to global regulatory bodies.
Technical Documentation: Design specifications, risk analysis, technical files, clinical evaluation reports, and post-market surveillance documentation.
Quality Management Documentation: ISO 13485 documentation, quality procedures, corrective and preventive action (CAPA) reports, and audit documentation.
Training Materials: User training guides, surgical technique guides, educational videos, and certification programs for healthcare professionals.
Product Labeling and Software: Device labels, packaging information, symbology, medical device software interfaces, and validation documentation.
EU IVDR Compliance and Global Regulatory Standards
The EU In Vitro Diagnostic Regulation (IVDR) has created urgent compliance needs for device manufacturers. Language Scientific provides expert translation of technical documentation for IVDR compliance, including performance evaluation reports, quality management documentation, and labeling requirements. We understand EU MDR requirements, FDA 510(k) and PMA pathways, ISO standards (particularly ISO 13485 and ISO 14971), and international symbology standards (ISO 15223).
Precision in Technical Translation
Medical device translation requires exceptional technical precision. Surgical instructions demand MD-level understanding of anatomy and surgical technique. Engineering specifications require technical precision. IFUs must balance technical accuracy with patient comprehension. Our matching process pairs device complexity with appropriate medical and technical expertise—ensuring mechanical engineers translate engineering specs, surgeons translate surgical technique guides, and clinicians translate patient-facing materials.
Pharmacy Translation Services
Pharmacies serving diverse patient populations face critical communication challenges. When patients cannot read or understand medication instructions in English, medication errors, adverse events, and non-adherence increase dramatically. Language Scientific provides comprehensive translation solutions that enhance patient safety and regulatory compliance.
Patient Instruction and Safety Label Translation
Our software-enabled translation platform allows pharmacies to provide customers with patient instructions (SIGs) and auxiliary warning labels in their preferred language, covering both standard and custom SIGs. Clear medication instructions in patients’ native languages ensure proper dosing, timing, drug interaction awareness, and compliance with warnings—all critical for medication adherence and safety.
Pre-Translated CMI Leaflets and Package Inserts
Access our library of pre-translated Consumer Medication Information (CMI) leaflets available for on-demand printing in over 20 languages including Spanish, French, Vietnamese, Italian, Polish, Korean, and Russian. This enables pharmacies to immediately provide patients with comprehensive medication information covering side effects, contraindications, proper usage, storage instructions, and emergency guidance in their native language.
On-Demand Phone Interpreting for Pharmacies
Available 24/7, our phone interpreting service in 150+ languages allows pharmacists to communicate effectively with patients in real-time, addressing specific medication questions, clarifying complex dosing schedules, explaining drug interactions, and ensuring patients understand critical safety information when written translations require additional clarification.
Pharmacy Website and Marketing Translation
Enhance your pharmacy’s reach by translating your website and marketing materials into multiple languages, making your services more accessible to diverse patient populations and building trust within multilingual communities.
Our Medical Translation Quality Methodology
Language Scientific’s unique methodology delivers consistently clear, accurate translation of high-value medical information through a rigorous, multi-layered approach.
Translators with Medical Credentials
All our medical translators and editors have relevant education, training, and work experience matching the subject matter they translate. Many hold MDs, PharmDs, or PhDs in medical sciences. Our ASKnetwork matching process pairs linguistic expertise with medical specialization at the same level of expertise as the source content. Surgical instructions are translated by surgeons. Cardiology studies are translated by cardiologists. Oncology protocols are translated by oncology specialists.
Multi-Level Quality Control System
Our meticulous quality control system is the most thorough in the industry, with checks and balances throughout the entire process—from project manager selection through final proofreading. Medical materials are translated by doctors and edited by linguists, combining medical accuracy with linguistic excellence. Independent review, medical professional certification of translation accuracy, and validation processes ensure every document meets the highest standards.
ISO Certifications and Regulatory Expertise
Our Quality Management System is ISO 9001:2015 and ISO 17100:2015 certified, demonstrating systematic quality processes and translation service best practices. We maintain a deep understanding of FDA, EMA, and PMDA regulatory requirements, extensive experience with compliance documentation, and provide certified translations meeting regulatory submission standards worldwide.
AI-Optimized Translation Solutions with Human Expertise
AI is redefining medical translation by enhancing accuracy, speed, and efficiency. Language Scientific’s AI-optimized translation solutions streamline the translation of complex medical documentation, enabling clear communication across the globe. However, we maintain a critical distinction: AI efficiency combined with expert human review.
By combining AI technology with expert human medical review, we deliver precise, reliable translations that meet the highest regulatory standards. We utilize translation memory tools and maintain comprehensive glossaries to ensure consistent terminology throughout all project materials, which improves efficiency and reduces costs for long-term programs while maintaining quality.
AI assists with efficiency, but human medical expertise remains essential for patient safety, regulatory compliance, and the nuanced understanding that only qualified medical professionals can provide.
Why Choose Language Scientific for Medical Translation
Complete Pricing Transparency: No PM fees or hidden fees—you receive straightforward, transparent pricing for every project.
Exceptional On-Time Performance: 99.7% of projects completed by promised deadline, supporting your critical regulatory and trial timelines.
Tested and Accredited Linguists: All linguists are tested and accredited by language pair and subject matter expertise, ensuring qualified professionals handle your content.
Rapid Response: Project Manager response time averages under 2 hours, ensuring your urgent questions and needs receive immediate attention.
Global Language Coverage: Translation services in 215+ global languages enable you to reach any market worldwide with consistent, accurate documentation.
Trusted by Industry Leaders: Pharmaceutical companies, CROs, medical device manufacturers, biotech companies, and healthcare managers rely on Language Scientific for their most sensitive documents.
Certified Translation Accuracy: All translations are certified for translation accuracy by medical professionals, providing the validation that regulatory bodies and quality systems require.
Frequently Asked Questions
What is the best way to translate clinical trial documents?
Partner with specialized medical translators who understand regulatory requirements, employ therapeutic area experts, maintain translation memories for consistency, implement multi-level quality review, and provide certified translations meeting FDA and EMA standards.
How do CROs manage clinical trial translation?
CROs typically partner with specialized medical translation providers that integrate with trial management systems, provide dedicated project managers, handle multiple languages simultaneously, maintain consistent terminology across sites, and ensure compliance with global regulatory requirements.
What documents must be translated for a global clinical trial?
Essential translations include informed consent forms, study protocols, case report forms, investigator brochures, patient-reported outcome questionnaires, recruitment materials, ethics committee submissions, regulatory correspondence, safety reports, and site training documentation for each participating country.
How do I translate an informed consent form for FDA or EMA submissions?
Use certified medical translators experienced in ICF translation, follow FDA 21 CFR Part 50 and EMA guidelines, conduct back-translation validation, ensure cultural appropriateness and readability at required grade levels, and maintain complete documentation of the translation process.
What are the requirements for multilingual clinical trial documentation?
Requirements include accurate medical terminology, regulatory compliance (FDA 21 CFR, ICH-GCP, EMA guidelines), cultural adaptation, rigorous version control, certified translations, back-translation validation for critical documents, consistent terminology across sites, and comprehensive documentation of translator qualifications.
How can sponsors speed up clinical trial translation without losing quality?
Accelerate timelines by engaging translators during protocol development, using parallel processing for simultaneous translation into multiple languages, leveraging translation memory technology, establishing clear workflows with complete source documents, and partnering with specialized providers experienced in rapid turnaround.
Can AI translation be used in clinical trials safely?
AI translation can assist with efficiency for certain non-critical documents and initial drafts, but human medical translation experts must review, edit, and validate all clinical trial documents—especially patient-facing materials, informed consent forms, and regulatory submissions—to ensure accuracy and compliance.
What languages must clinical trial documents be translated into?
Translation languages depend on trial site locations and enrollment geography. Common requirements include major European languages (Spanish, German, French, Italian, Portuguese), Asian languages (Japanese, Chinese, Korean), and languages of emerging markets based on study design.
How do I ensure accuracy and regulatory compliance in clinical trial translation?
Ensure compliance by using ISO-certified translation providers, employing translators with relevant medical expertise and credentials, implementing independent quality review by medical professionals, conducting back-translation validation, maintaining complete audit trails, and following country-specific regulatory guidelines.
Get Started with Language Scientific Medical Translation
Whether you’re conducting global clinical trials, preparing regulatory submissions for multiple markets, translating medical device documentation for international market entry, or serving diverse patient populations at your pharmacy, Language Scientific delivers the medical expertise, regulatory knowledge, and linguistic precision your projects demand.
Our team of medical professionals—MDs, PharmDs, PhDs, and specialized medical translators—stands ready to support your most critical medical translation needs. With 215+ languages, ISO-certified quality processes, AI-optimized efficiency combined with human medical oversight, and a track record of 99.7% on-time delivery, we provide the reliability global healthcare and life sciences organizations require.
Contact Language Scientific today at https://www.languagescientific.com/ to discuss your medical translation needs. Our expert team responds within 2 hours to provide guidance, answer questions, and deliver transparent pricing for your specific requirements.
Request a quote and discover why pharmaceutical companies, CROs, medical device manufacturers, and healthcare organizations trust Language Scientific for their most critical medical translation projects. Your patients are global. Your documentation should be too.
