Clinical and regulatory translation
Protocols, consent forms, investigator brochures, labelling and regulatory correspondence translated by life sciences specialists.
Sector: Pharmaceutical and clinical research
Translation for pharmaceutical, medical device and clinical research teams
SILA Linguists provides sponsors, CROs, biotech companies and device manufacturers with accurate translation of regulated and patient-facing content across many markets.
Life sciences translation is shaped by regulation. In Europe, product information for medicines is published in many languages using standard regulatory templates, and each country decides the languages required for medical device labels and instructions for use. Clinical trials add patient-facing documents for every site and country.
SILA Linguists translates clinical, regulatory and commercial content with linguists who understand medical and scientific terminology. We follow sponsor glossaries and regulatory templates, keep document versions under control, and can arrange independent review or back translation where a protocol or ethics committee requires it.
Patient-facing content needs plain, natural language as much as technical accuracy. Consent forms, patient diaries and questionnaires must be understood by participants with different levels of education, and that takes translators who write well for the public as well as for regulators.
What this sector needs
Language challenges in life sciences
Informed consent across sites
Participant information and consent forms must be accurate, readable and approved for each country and language in a trial.
Regulatory templates
Labelling, package leaflets and summaries of product characteristics must follow agency templates and standard terms.
Device labelling and IFUs
Medical device labels and instructions for use must meet the language rules of each market where the device is sold.
Validated questionnaires
Patient-reported outcome measures may need back translation and reconciliation so that results are comparable between countries.
Version control
Protocol amendments and updated documents must flow through every language without losing track of approved versions.
Scientific communication
Publications, conference materials and medical information responses need specialist translators and, at events, interpreters.
How we help
Services for life sciences
Research translation
Translation of study reports, publications, questionnaires and qualitative research data.
Technical document localisation
Instructions for use, device manuals and laboratory documentation in the required format.
Conference and simultaneous interpreting
Interpreting for investigator meetings, advisory boards and scientific congresses.
Video and remote interpreting for studies
Interpreters for patient visits, monitoring calls and qualitative interviews.
SILA Linguists®
SILA Linguists® translation and interpreting for pharmaceutical, biotech and medical device teams
Our vetted, trained and qualified life sciences translators can support sponsors, contract research organisations, biotech companies and medical device manufacturers with regulated and patient-facing content in many markets. Our translators handle participant information and consent forms, clinical trial protocols, investigator brochures, patient diaries and questionnaires, summaries of product characteristics, labels and package leaflets, instructions for use and pharmacovigilance case reports. Research translation follows established methods such as back translation and reconciliation, and technical document localisation keeps device documentation consistent across every language. Glossaries and translation memories keep terminology aligned with approved product information across every study and market.
Where a translation must be formally attested, for example for ethics committees, regulators or courts, we provide certified translation with a signed statement of accuracy accepted by UK authorities and courts. Patient interviews, advisory boards and cognitive debriefing sessions can be supported by video remote interpreting or telephone interpreting and then delivered as translated transcription. Investigator meetings and scientific congresses are supported by conference interpreting and simultaneous interpreting, and patient apps and e-learning go through software and multimedia localisation. Linguists are briefed on the study design before each session.
Life sciences work runs closely with our healthcare, engineering and technology services. SILA Linguists® covers more than 350 languages and dialects, including German, French, Spanish, Japanese, Mandarin and Polish, for organisations in the UK, North America, Australia, New Zealand and beyond. Every linguist signs a confidentiality agreement, and study data and patient information are handled under UK GDPR and the data protection rules of each project. One project manager coordinates translation, interpreting and transcription across the countries and sites of each study.
Questions
Frequently asked questions
Can you provide back translation for questionnaires and consent forms?
Yes. We provide an independent back translation by a different linguist and a reconciliation report, which many ethics committees and outcome measure developers expect.
Do you follow regulatory templates and sponsor glossaries?
Yes. We apply the relevant regulatory templates and your approved terminology so that translations are consistent with earlier submissions.
How do you handle confidential trial data?
We work under NDA, follow GDPR, and limit access to the named linguists on the project. Patient data is handled only to the extent the translation requires.
Can you interpret for patient visits in a trial?
Yes. Our medical interpreters support study visits face to face or remotely, and are briefed on the protocol terminology before the visit.
Get in touch
Tell us the language, the format and the date
Our bookings team will confirm the details with you and arrange the right linguist. Have the language (and dialect, if you know it), the type of assignment and the date ready.