Life Science Translation Services

Language Scientific is the only translation company with deep medical, regulatory and language understanding that enables customized, reliable and timely completion of each translation.

Life Science Translation Expertise

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

Other Industries

At Language Scientific, we deliver expert translation services for the life sciences sector, helping you communicate effectively and comply with global standards across pharmaceuticals, healthcare, hospitals, biotechnology, and more.
  • Pharmacy Services:
    On-demand translation of SIGs, auxiliary labels, medication leaflets, and interpreting services to enhance LEP patient safety and regulatory compliance.

  • Healthcare:
    Comprehensive translations for medical records, discharge instructions, patient education materials, and multilingual communication solutions to support high-quality care for LEP patients.

  • Hospitals:
    Localized translations of protocols, signage, informed consent forms, and patient instructions to facilitate clear communication and ensure compliance in diverse patient populations.

  • Biotechnology:
    Comprehensive translation services for research documentation, patent filings, and marketing materials to support innovation and global partnerships.

What Makes Translating A Medical Document More Difficult Than Translating Any Other Document?

Can you paraphrase the following sentence?

“The test suggests that the additional cannula from the visceral pleura resulted in pulmonary function improvements in the approximate range of 500% from forced expiratory volumes in one-second (FEV1) measurements.”

If you didn’t have a background in medicine, you probably couldn’t. Translation is, fundamentally, paraphrasing. Would you entrust your FDA documentation or Adverse Event Reports to a translator without an MD?
At Language Scientific, we hold to the principle:

“If You Don’t Understand It, You Cannot Translate It!”

That is why Language Scientific requires all Medical Translators and Translation Editors have education, training and work experience in the Life Science Industry matching the subject matter they translate. Our meticulous Quality Control system is the most thorough in the industry, with a system of checks and balances in place throughout the entire process—from the selection of project managers to the final proofreading of the translated document.

Clients Rely On Our Life Science Expertise

Pharmaceutical companies, clinical research organizations (CROs), manufacturers of medical and surgical devices, biotech companies and healthcare managers have come to rely on Language Scientific for translation of their most sensitive documents. Our unique methodology that clients depend on delivers consistently clear, accurate translation of high-value information.

We Translate And Localize For:

  • Biotechnology Companies such as Affymetrix, Amgen and Biogen Idec
  • Multinational Pharmaceutical Companies such as Pfizer, Merck, Novartis and Novo Nordisk
  • Pharmaceutical Manufacturers such as Alere and Valeant Pharmaceuticals
  • Medical Devices Companies such as Gendex, American Medical Systems and Stryker Medical Devices Technology
  • Clinical Research Organizations (CRO) such as Quintiles and PRA International

Regulatory Compliance and Certification of Translation Accuracy

Medical translation requires precision and up-to-date technical knowledge by every member of your translation team. It also requires multiple levels of quality control and a full understanding of stringent regulatory laws, especially the US, the European Union and Japan.

Whether translating patient case report forms for FDA submission or packaging for in-vitro devices to comply with the EU’s IVDD directive, there can be no compromise where the spheres of language and healthcare regulation converge. That is why our translations are translated and Certified for Translation Accuracy by Medical Professionals.

Language Scientific’s Quality Management System is ISO 9001:2015 and ISO 17100:2015 certified.

Types of Life Science Documents We Translate

Research & Development

  • Patents
  • Scientific Articles
  • Lab Reports
  • Validation Reports
  • Japan’s PMDA Audit Support
  • IND and NDA Documentation for EMEA
  • Japan’s PMDA, and China’s SFDA
  • Declaration Of Conformity
  • Adverse Event Report Forms
  • Informed Consent Forms (ICFs)
  • Validation Reports
  • Patient Diaries

Regulatory Affairs

  • Registration Dossiers
  • CMC Documentation
  • Labels and Package Inserts
  • Instructions For Use (IFUs)
  • Case Report Forms (CRFs)
  • Site Operations Manuals
  • Institutional Contracts
  • IVRS Prompts
  • Adverse Event Reports (SAEs)
  • Video Informed Consent
  • Patient Reported Outcomes (PROs)

Clinical Research

  • Study Protocols
  • IRB/Ethics Committee Submissions
  • Clinical Trial Agreements (CTAs)
  • Investigator Brochures
  • eLearning
  • Multimedia
  • Sales Training
  • Patient Education (CMI and PHI)
  • Deviation Reports
  • Data Sheets
  • QMS Audit Documentation

Sales & Marketing

  • Websites – Professional / Consumer
  • Software and Hardware
  • Promotional Materials
  • Marketing Collateral
  • Manufacturing
  • GMP Documentation
  • SOPs
  • Batch Records and MBRs
  • Pharmacovigilance and Postmarketing Surveillance
  • Patient Recruitment Materials
  • Patient Questionnaires

Life Science Subjects We Translate

We have vast experience translating Life Science documents in a wide variety of scientific fields. For example, in the past three years we translated medical documents, clinical data and medical device software in the fields of:

 

  • Biotechnology
  • Genetics
  • Oncology
  • Anatomy
  • Botany
  • Genomics
  • Optometry
  • Biomedical science
  • Cell biology
  • Health sciences
  • Parasitology
  • Biochemistry
  • Cognitive neuroscience
  • Immunogenetics
  • Pathology
  • Biocomputers
  • Computational neuroscience
  • Immunology
  • Pharmacogenomics
  • Biocontrol
  • Conservation biology
  • Immunotherapy
  • Pharmacology
  • Biodynamics
  • Developmental biology
  • Marine biology
  • Physiology
  • Bioinformatics
  • Ecology
  • Medical devices
  • Population dynamics
  • Biology
  • Ethology
  • Medical imaging
  • Proteomics
  • Biomaterials
  • Environmental science
  • Microbiology
  • Sports science
  • Biomechanics
  • Evolutionary biology
  • Molecular biology
  • Structural biology
  • Biomonitoring
  • Evolutionary genetics
  • Neuroethology
  • Systems biology
  • Biophysics
  • Food science
  • Neuroscience
  • Zoology
  • Biopolymers

Linguistic Validation of Clinical Instruments and PROs

Patient Reported Outcomes (PROs) questionnaires are a critical tool for gathering valuable insight into symptoms, side effects and safety of investigational drugs, and these questionnaires are widely used in global clinical trials. However, the instruments’ validity across international sites requires not just translation and cultural adaptation, but linguistic validation and harmonization across languages and locales. Language Scientific has provided Linguistic Validation of Patient Reported Outcomes (PRO) questionnaires and other clinical instruments for over 20 years. We have translated questionnaires into over 60 world languages.

The Role of AI in Medical Translation

AI is redefining medical translation by ensuring accuracy, speed and regulatory compliance. Our AI-optimized translation solutions streamline the translation of complex medical documentation, enabling clear communication across the globe. By combining AI efficiency with expert human review, CROs can deliver precise, reliable translations that meet the highest regulatory standards.