What Makes Translating A Medical Document More Difficult Than Translating Any Other Document?
Language Scientific specializes in providing Biotechnology Translation services.
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
Biotechnology 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 systems are ISO 9001:2015 and ISO 17100:2015 certified.
Biotechnology Translation Experience:
- Research & Development
- Regulatory Affairs
- Clinical Research
- Sales & Marketing
- Registration Dossiers
- Study Protocols
- Websites – Professional / Consumer
- Scientific Articles
- CMC Documentation
- IRB/Ethics Committee Submissions
- Software and Hardware
- Lab Reports
- Labels and Package Inserts
- Clinical Trial Agreements (CTAs)
- Promotional Materials
- Validation Reports
- Instructions For Use (IFUs)
- Investigator Brochures
- Marketing Collateral
- Japan’s PMDA Audit Support
- Case Report Forms (CRFs)
- IND and NDA Documentation for EMEA
- Site Operations Manuals
- GMP Documentation
- Japan’s PMDA, and China’s SFDA
- Institutional Contracts
- Sales Training
- Declaration Of Conformity
- IVRS Prompts
- Patient Education (CMI and PHI)
- Batch Records and MBRs
- Adverse Event Report Forms
- Adverse Event Reports (SAEs)
- Deviation Reports
- Pharmacovigilance and Postmarketing Surveillance
- Informed Consent Forms (ICFs)
- Video Informed Consent
- Data Sheets
- Patient Recruitment Materials
- Validation Reports
- Patient Reported Outcomes (PROs)
- QMS Audit Documentation
- Patient Questionnaires
- Patient Diaries
Languages We Translate
Language Scientific works in over 215 global languages. That is important when translating clinical trial documentation, due to increasing globalization of clinical research. Nevertheless, most of our biotechnology translation work involves translation between English and the major Asian, American, European and Middle Eastern languages, such as Chinese, Dutch, French, German, Hebrew, Italian, Japanese, Korean, Portuguese, Russian and Spanish.
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:
- Affective neuroscience
- Biomedical science
- Cell biology
- Health sciences
- Cognitive neuroscience
- Computational neuroscience
- Conservation biology
- Developmental biology
- Marine biology
- Medical devices
- Population dynamics
- Medical imaging
- Environmental science
- Sports science
- Evolutionary biology
- Molecular biology
- Structural biology
- Evolutionary genetics
- Systems biology
- Food science
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 15 years. We have translated questionnaires into over 60 world languages.