OSI is a specialist language services partner for market research, healthcare, and life sciences — bridging languages, cultures, and markets with precision and deep sector expertise.
From survey localisation to regulatory translation, we deliver the depth of expertise your sector demands — not generic language services.
Medical, pharmaceutical and market research translation by specialist linguists who understand your industry — not just your language.
Learn more →Programming-ready survey translations delivered in the exact format your platform or scripting team needs — structured, clean, and import-ready.
Learn more →Pre-fieldwork quality assurance on live survey links in every target language — so problems are caught before they corrupt your data.
Learn more →Verbatim translation of open-ended responses that preserves respondent voice, sentiment, and nuance — ready for analysis.
Learn more →Bilingual moderators and interpreters who bring both linguistic expertise and genuine qualitative research experience to every session.
Learn more →Research-grade transcription of audio and video sessions — verbatim or intelligent verbatim — with translation and subtitling options.
Learn more →Systematic review of verbatim responses, qualitative recordings, and open-ended survey responses for adverse event disclosures — compliant with BHBIA and EPhMRA guidelines.
Learn more →Rigorous multi-stage validation of COAs, PROs, and all patient-facing instruments — following FDA, EMA, and ISPOR standards for regulatory submission.
Learn more →Our clients operate where precision is non-negotiable. We understand the pressures of your sector — compliance requirements, data quality standards, tight fieldwork windows — and we're built to meet them.
We invest time upfront understanding your project, audience, methodology, and outcomes — nothing is lost in the brief before a word is translated.
We assign linguists with demonstrable expertise in your specific sector and target market — not generalists pulled from a database.
Rigorous QA at every stage — translation, adaptation, back-translation where required — so you can trust the output completely.
On time, in your preferred format, with a dedicated project manager on hand for any queries throughout the lifecycle.
Tell us about your next project — no commitment required, just a conversation with a specialist who understands your world.
Get in TouchFrom the moment a survey is designed to the final insight report, OSI supports every language touchpoint in the research process — with specialists who understand your industry, not just your language.
Medical, pharmaceutical and market research translation by specialist linguists with deep sector knowledge and rigorous quality assurance.
Explore service →Programming-ready survey translations delivered in your platform's native format — Qualtrics, Decipher, Confirmit and more.
Explore service →Pre-fieldwork QA on live survey links — catching character encoding issues, broken logic, and display errors before they reach respondents.
Explore service →Verbatim translation, language summarisation, and thematic coding of open-ended responses — preserving voice while enabling analysis.
Explore service →Bilingual qualitative moderators and interpreters experienced in IDIs, focus groups, and online communities across global markets.
Explore service →Research-grade audio and video transcription, multilingual transcript translation, and professional subtitling for qualitative content.
Explore service →Systematic review of verbatim responses, interview transcripts, and qualitative recordings for adverse event disclosures — compliant with BHBIA and EPhMRA guidelines.
Explore service →Rigorous multi-stage validation of COAs, PROs, and patient-facing instruments — following FDA, EMA, and ISPOR standards for regulatory submission.
Explore service →Don't see exactly what you need? Our work spans far beyond these core services.
Discuss Your RequirementsOur team will help you scope the right solution for your project — fast, no obligation.
Talk to a SpecialistPrecision translation for market research, healthcare and life sciences — by linguists who understand your sector, your methodology, and the stakes involved.
Generic translation agencies can handle the words. What they can't handle is the context — the methodological nuance in a survey instrument, the regulatory precision in a clinical document, or the patient-facing sensitivity in a healthcare communication. That's where OSI is different.
Our translators are selected for dual expertise: fluency in the target language and demonstrable knowledge of your industry. Every project is matched to a linguist who has worked in your specific domain — not a generalist assigned from a pool.
The OSI difference: We don't just translate your documents. We take on the responsibility of ensuring the translated content performs as intended in the target market — linguistically, culturally, and professionally.
Every project is allocated to linguists with verified expertise in your sector. We maintain detailed profiles on each translator in our network — including their academic background, industry experience, and subject matter specialisms.
All translations go through a minimum two-step process: subject-matter specialized translation, followed by review from a fully independent qualified linguist. For regulatory or clinical content, we apply additional validation steps including back-translation and reconciliation where required.
We build and maintain project-specific glossaries and translation memories for all ongoing clients — ensuring consistency across waves, documents, and markets. This is especially critical for longitudinal research programmes and global regulatory submissions.
Consistent, culturally adapted translations across 5–50+ markets for tracker studies, ad-hoc projects, and segmentation research.
Certified translations of clinical trial documentation, ICFs, SmPCs, and patient-facing materials for regulatory submission.
Patient information materials, HCP communications, and educational content adapted for local markets with clinical accuracy.
Discussion guides and stimulus materials translated for expert network interviews and KOL research across global markets.
We cover 100+ languages across Europe, the Americas, Asia-Pacific, Middle East, and Africa. Our network includes native-speaker translators in markets including all major European languages, BRICS nations, and emerging research markets. Contact us for specific language availability.
Share your brief with us — we'll respond with a tailored proposal within 24 hours.
Get in TouchTranslations of online survey scripts delivered in the exact format your programming team or platform needs — structured, clean, and ready to import.
When a translated survey is delivered as a plain Word document, your programming team has to manually transfer every question, every answer option, every routing instruction into your survey platform. This introduces errors, adds time, and creates a quality risk at the worst possible moment — just before fieldwork launches.
OSI's language overlay service eliminates this problem. We deliver translations in the precise structure your survey platform or scripting team requires — preserving all variable names, codes, routing logic, and display conditions exactly as they appear in the source.
The result: Translations that go straight from OSI into your survey platform with minimal manual intervention — reducing errors, speeding up scripting, and protecting data quality.
We work with all major survey platforms and scripting environments. Our delivery formats include native platform import files, structured Word/Excel overlays with coded columns, and platform-specific XML or JSON exports.
QSF import files with all language variants nested within the base survey structure.
XML overlays preserving all element IDs, logic, and skip patterns.
Structured Word or Excel overlays with a column format matched to your scripting team's workflow.
Survey language overlay isn't just about translation — it's about understanding how surveys work. Our trained overlay teams are briefed on survey methodology so they understand how the translation in a Word document must be transmuted to the translation seen by an online respondent. This means navigating through programming code with unexpected logic changes, and real-time problem solving where different natural language grammatical structures must fit into programming written with one language in mind.
Let us show you how overlay delivery can cut your scripting time and reduce pre-fieldwork errors.
Talk to Our TeamA translated survey can pass internal review and still fail in the field. Our in-language testers find the problems your scripting team can't see — before they cost you data.
Even a perfectly translated survey can break when it goes live. Character encoding issues cause question text to appear as symbols. RTL language layouts fail on certain browsers. Routing logic that works in English breaks when translated text changes string lengths. Answer options that display correctly in the preview appear out of order to respondents.
Language link checking is the final quality gate before fieldwork opens. OSI assigns native-speaking in-country testers to review each live survey link in each target language — completing the survey from a respondent's perspective and logging every issue they encounter.
Industry fact: Studies show that up to 30% of multilingual surveys contain at least one language-specific display or logic issue at launch. Link checking is the only way to be certain.
We receive the live survey link(s) along with a completed English version for reference and any known logic notes.
A native-speaking tester from the target market completes the survey from a respondent's perspective, logging all issues.
We deliver a structured issue log with severity ratings, screen-level descriptions, and suggested fixes for your programmers.
After fixes are applied, we re-test the flagged items and provide sign-off confirmation for each language.
Any online survey launching in a language other than the scripting language should be link-checked. It is especially critical for:
One hour of testing can save a week of fieldwork damage. Talk to us about adding link checking to your multilingual workflow.
Contact Our TeamWhen your respondents answer in their own language, you need those insights in English without losing nuance, sentiment, or meaning. That's exactly what OSI delivers.
Open-ended survey responses are where the real insights live. They're also where poor translation causes the most damage — turning nuanced, market-specific responses into bland, flattened summaries that lose the very detail your analysts need.
OSI's open ends service is built around one principle: preserve what the respondent actually said. Our translators work to maintain tone, register, and meaning — not just transfer words from one language to another. The result is verbatim data that analysts can work with directly.
Full translation of each open-ended response, preserving the respondent's exact meaning, tone, and language style. No paraphrasing, no summarisation — just accurate, readable English (or target language) equivalents.
For large volumes of responses in a single language, we provide thematic summaries that capture the range and frequency of key themes — useful when full verbatim translation isn't required.
We apply a client-supplied or OSI-developed coding frame to translated responses, categorising each by theme to accelerate analysis and reporting.
Each translated response flagged for overall sentiment (positive / neutral / negative / mixed) — enabling quick quantitative analysis of qualitative data.
Open ends are never processed by machine translation alone. Every response is handled by a human translator who has been briefed on the research context, the survey topic, and the analytical purpose. This context-awareness is what separates OSI from bulk translation services.
For pharmaceutical and healthcare market research, open-ended responses carry an additional obligation. When respondents discuss their experiences with treatments, medications, or healthcare, they may spontaneously disclose adverse events — and under BHBIA and EPhMRA guidelines, these disclosures must be identified and reported.
OSI offers Adverse Events Checking as an integrated add-on to the open ends service. Rather than sending your translated responses to a separate team for review, we can perform the AE check as part of the same workflow — with linguists who already have the research context. Any identified adverse events are flagged in a structured report and returned alongside your translated data, ready for handover to your pharmacovigilance or medical affairs team.
One workflow, two outputs: Translated open ends and a structured AE report — delivered together, without the need to coordinate two separate suppliers.
We handle everything from small surveys (50–100 responses) to large-scale quantitative projects with tens of thousands of open-ended responses across multiple markets. Contact us for volume pricing and turnaround estimates.
Let our specialists handle the translation so your analysts can focus on what matters — the findings.
Talk to Our TeamQualitative research depends on depth of conversation. Our bilingual moderators and interpreters bring the linguistic fluency and research expertise to make every session count.
Running qualitative research in multiple markets isn't just a translation challenge — it's a human one. You need people who can build rapport, probe intelligently, and follow your discussion guide in ways that generate genuine insight. That requires both linguistic ability and research methodology experience. It's a rare combination. OSI has built a network of exactly these people.
Our moderators are researchers first. They understand the difference between a probing question and a leading question, when to let a respondent run and when to redirect, and how to translate not just words but the research intent behind them.
When you want to keep your own moderator but need language access, OSI provides experienced research interpreters who deliver:
Every moderator receives a thorough briefing that includes: the research objectives, target respondent profile, discussion guide walkthrough, any sensitive topic areas, and the client's preferred probing style. For healthcare and pharmaceutical research, we include relevant therapeutic area or product context. We don't just hand over a discussion guide and hope for the best.
We have established moderator and interpreter networks across Europe, North America, Latin America, Asia-Pacific, and the Middle East. If you have a market in mind, ask us — we can usually source the right person within 24–48 hours.
Share your brief and we'll propose the right person — with a sample of their work where available.
Send Us a BriefAccurate, analysis-ready transcripts and subtitles for qualitative research sessions — in any language, in any format, at any volume.
Getting qualitative sessions transcribed accurately — when recordings feature multiple speakers, technical terminology, accents, and sometimes background noise — is genuinely difficult. Getting them transcribed in a non-English language, and then translated into English for analysis, requires a specialist partner who understands both the research context and the linguistic demands.
OSI's transcription service is built specifically for market research. We transcribe focus groups, IDIs, online communities, ethnographies, and expert interviews — in the target language and translated into English if required — to a standard that analysts can work with directly.
For qualitative video content — recruitment videos, session recordings, stimulus materials, or highlight reels — OSI provides professional subtitling that is accurate, timed correctly, and formatted for your intended platform.
All transcripts are further reviewed with a particular emphasis on correct medical terminology and product names. For foreign-language transcripts that are also translated, the translator works from the original audio — not just the transcript — to ensure no nuance is lost in the two-step process.
Send us a sample recording and we'll demonstrate our quality before you commit to a full project.
Get in TouchOSI works exclusively within sectors where language precision is non-negotiable — market research, healthcare, pharmaceutical, and life sciences. Our depth of sector knowledge is what sets us apart.
Survey localisation, qualitative fieldwork support, transcription, and open ends translation for the full research lifecycle — at any scale, in any market.
Explore →Patient materials, HCP communications, and healthcare research translation — delivered with the clinical accuracy and cultural sensitivity the sector demands.
Explore →Regulatory submissions, clinical trial documentation, and pharmaceutical research translation — precision work for a sector where accuracy is a legal requirement.
Explore →From discovery-phase research to market access, OSI supports the full life sciences journey with specialist translation and language services.
Explore →Talk to a specialist who understands the specific demands of your industry.
Speak to Our TeamWhen your data spans 20 markets and six languages, the quality of your translation partner determines the quality of your insights. OSI is built for exactly this.
A standard translation agency can translate your survey. Only a specialist in market research language services can translate it in a way that maintains data comparability, cultural equivalence, and methodological integrity across markets.
Some concepts don't exist in certain languages. Some scales perform differently across cultures. OSI identifies and resolves these issues during translation — not after fieldwork.
This challenge runs deeper in healthcare and pharmaceutical research. Healthcare systems differ significantly between countries — practice settings, prescribing patterns, and medical specialties are not equivalent across markets. A survey designed with one market in mind will often contain elements that are irrelevant, ambiguous, or entirely incompatible in another. OSI deploys locally situated linguists who are trained to identify these issues and work with research teams to resolve them — whether that means adapting a question, flagging an incompatibility for the client, or proposing a market-specific alternative that preserves the research intent.
Market research runs on tight deadlines. We're structured to deliver translations, overlays, and link checks within the windows that research projects actually operate on.
Where projects demand it, we operate on expedited timelines — including weekend work upon request. Our project management team is globally distributed, from Bangkok to London to Los Angeles, enabling seamless handovers across timezones so that work continues around the clock and nothing waits for a desk to open in the morning.
Tracker studies require identical terminology across waves. We maintain translation memories and glossaries for every long-term client to guarantee consistency year on year.
Beyond documentation, we strive to assign the same linguist team to each wave of a tracker study — preserving not just terminology, but the nuanced judgement calls that experienced translators make within a specific research programme. We also conduct additional wave-on-wave reproducibility checks, comparing new translations against approved prior-wave content to catch any drift before it reaches the data.
Survey instruments rarely reach the field unchanged. As questionnaires evolve — through client feedback, pilot testing, programming constraints, or end-client review cycles — translated versions must keep pace. OSI tracks changes between drafts, applies targeted updates to approved translations, and implements stakeholder comments with precision. We maintain clear version histories so every market remains in sync, and flag where wording changes may affect data comparability across waves.
Programming-ready survey translations for all major platforms — delivered in your scripting format.
Pre-fieldwork QA on all live survey links to catch errors before they reach respondents.
Verbatim translation of open-ended responses for seamless analysis across all markets.
Bilingual moderators and interpreters for IDIs, focus groups, and online communities worldwide.
Research-grade transcription of qualitative sessions in any language, with translation options.
Specialist translation of survey instruments, discussion guides, and research materials.
Compliant review of verbatim responses and qualitative recordings for adverse event disclosures — aligned with BHBIA and EPhMRA guidelines.
Multi-stage COA and PRO validation following FDA, EMA, and ISPOR standards — covering forward translation, back-translation, and cognitive debriefing.
We support the complete research lifecycle — from survey design through to final reporting — across any number of markets and languages.
Fast, reliable multilingual survey delivery for panel providers running concurrent fieldwork in multiple markets.
Language overlay and QA services that slot seamlessly into platform-based survey workflows.
Discussion guide translation and bilingual moderation for expert network interviews and KOL research programmes.
Join the market research agencies who trust OSI to protect their data quality across every market.
Talk to Our TeamIn healthcare, a mistranslation isn't just an error — it can affect patient safety, regulatory compliance, and clinical outcomes. OSI delivers the accuracy this sector demands.
Healthcare translation requires more than linguistic competence. It requires clinical knowledge, cultural sensitivity, and a rigorous quality process that reflects the seriousness of the sector.
Patient-facing materials — information leaflets, consent forms, medication instructions — must be translated with absolute accuracy. An ambiguous phrase can affect patient behaviour and outcomes.
Healthcare documentation submitted to regulatory bodies must meet specific accuracy standards. Substandard translation can delay submissions or trigger requests for revision.
Materials for healthcare professionals must use correct clinical terminology and reflect local practice norms — requiring translators with genuine medical knowledge.
Patient recruitment materials, PRO instruments, and health outcome surveys require culturally adapted translations that maintain measurement validity across populations.
Accurate, clinically reviewed translation by linguists with healthcare sector expertise.
Bilingual moderation for patient focus groups, IDIs, and ethnographic healthcare research.
Transcription of patient interviews, clinician discussions, and medical education sessions.
Systematic review of research outputs for spontaneous adverse event disclosures — supporting your pharmacovigilance obligations across languages.
Rigorous validation of patient-facing instruments and COAs for use in clinical research and regulatory submissions — aligned with FDA and EMA guidance.
Talk to a specialist who understands the clinical, regulatory, and cultural dimensions of healthcare language services.
Speak to a SpecialistClinical trials, regulatory submissions, pharmacovigilance documentation — OSI delivers pharmaceutical translation services that meet the precision standards the industry requires.
Pharmaceutical translation isn't just linguistically demanding — it's legally and ethically significant. The documents you submit to regulators, share with trial participants, and distribute to healthcare professionals must be accurately translated by people who understand both the science and the regulatory context.
Marketing authorisation applications, SmPCs, and PILs must be translated with absolute terminological consistency and accuracy. Regulators in different markets have specific expectations — our translators know them.
Protocol translations, ICFs, eCRFs, and patient diaries must be clear to participants while maintaining scientific precision. The wrong word can affect data quality and participant safety.
Adverse event reports, safety narratives, and PV documentation require fast, accurate translation to meet regulatory timelines. OSI provides rapid-turnaround PV translation without compromising quality.
Physician and patient surveys, concept testing, and advisory board materials all require specialist translators who understand pharmaceutical terminology and research methodology.
Regulatory-grade pharmaceutical translation for clinical documents, submissions, and market research materials.
Guideline-compliant review of multilingual research outputs for adverse event disclosures — aligned with BHBIA, EPhMRA, and GVP obligations.
Translation of verbatim patient and HCP responses from multilingual surveys for analysis and pharmacovigilance review.
Bilingual moderation for pharmaceutical advisory boards, KOL interviews, and patient research across global markets.
Full multi-stage LV services for PROs, ClinROs, ObsROs, and PerfOs — regulatory-grade documentation for FDA, EMA, and global submissions.
Tell us about your project — we'll scope the right approach and turn around a proposal within 24 hours.
Request a ProposalThe life sciences sector spans research, clinical development, regulation, and commercialisation. OSI supports every language need across that journey — with the scientific accuracy it demands.
Life sciences communication is inherently global — research is conducted internationally, products are developed for multiple markets, and clinical evidence must be communicated to diverse audiences. Every step requires language services that combine scientific expertise with cultural awareness.
Biomedical terminology must be translated with exactness — a single mistranslated term in a clinical document can have serious downstream consequences. Our translators hold relevant scientific qualifications.
Multi-site, multinational studies require consistent, comparable data. OSI supports the translation infrastructure that makes truly global research possible.
Getting a product to market in multiple countries requires high-volume regulatory translation on tight timelines. We're built to deliver this at scale.
Communicating complex science to investors, clinicians, payers, patients, and regulators — each audience requires a different approach. OSI understands these distinctions.
Publications, research reports, and scientific documentation by qualified specialist translators.
Market authorisation documents, clinical summaries, and regulatory dossiers with precision accuracy.
Patient and HCP survey translation for life sciences market research programmes worldwide.
Bilingual moderation of patient and KOL research across life sciences therapeutic areas.
Research interview and advisory board transcription in any language for life sciences organisations.
Verbatim translation of qualitative survey responses for life sciences research programmes.
From early-phase research to global launch — OSI is built to support life sciences organisations at every stage.
Talk to Our TeamOSI was founded by scientists with backgrounds in Chemistry and Life Sciences — professionals who understood firsthand how much precision matters when specialist knowledge meets language. That founding conviction remains unchanged: quality language services in specialist sectors require genuine sector expertise, not just linguistic skill. Organisations running market research across 30 markets, or submitting regulatory documents in 15 languages, need a partner who can navigate the complexity they face every day.
We have spent over 20 years building deep knowledge in market research, healthcare, and life sciences — assembling a network of linguists, moderators, and consultants who understand not just the language, but the industry context in which it operates.
Our tagline — Communicate Simply — reflects our philosophy. No matter how complex the subject matter or how many markets are involved, our job is to make communication clear, accurate, and effective.
OSI operates globally, with team members and partners located across London, Vilnius, Zurich, Sofia, Philadelphia, Cleveland, Los Angeles, Puebla, and Bangkok — giving us the reach and time-zone coverage to support projects wherever and whenever they run.
In specialist sectors, close enough isn't good enough. We apply rigorous quality processes at every step — not because it's policy, but because the consequences of error are real.
We work only in industries we genuinely understand. Our linguists are selected for dual expertise — language ability and industry knowledge — because translation without context fails.
Our best client relationships are long-term. We invest in understanding your organisation, your methodology, and your standards — so we can anticipate needs rather than just respond to them.
OSI was established with a clear focus: language services for market research and healthcare — sectors where generic solutions consistently fall short.
Built a dedicated network of bilingual moderators, transcriptionists, and interpreters specifically for qualitative market research, covering 50+ countries.
We extended our network and expertise into pharmaceutical translation and clinical research, responding to growing demand from CROs and pharma organisations.
OSI is the language partner of choice for leading market research agencies, pharmaceutical companies, and healthcare organisations worldwide.
OSI is an active member of the industry associations that set the standards for market research, healthcare research, and pharmaceutical sectors globally.
Let's start a conversation about your language service requirements — no obligation, no sales pressure.
Get in TouchPractical guidance, industry perspectives, and expert commentary on language services for market research, healthcare and life sciences.
We welcome guest contributors from the market research, healthcare, and life sciences community.
Get in TouchWe'd love to discuss how we can support your next project.
Contact Our TeamWhether you have a specific project in mind or just want to explore how OSI can support your language needs — we'd love to hear from you.
This privacy policy outlines OSI's practices concerning personal data collection and usage. We may collect and store limited information related to prospective and existing client contacts, employees, supplier contacts, contract workers and written correspondents for the purpose of carrying out our business and engaging in business-related correspondence. This policy explains how we handle such data.
By interacting with our Website and/or with representatives of OSI you indicate your acceptance of this Privacy Policy.
We may collect and process the following types of information:
The data collected is used solely for the purpose of conducting our business activities, carrying out our legal obligations, and/or for security purposes which may include:
The Lawful Bases for collecting and storing this information are: Consent, Legitimate Interest, Contract and/or Legal obligation.
We do not act as list providers / brokers. We will not sell and, except when legally obligated, we will not pass on personal data to third parties without consent.
We take appropriate measures to ensure the security and confidentiality of the data we collect. Access to this data is limited to authorized personnel only, and we use industry-standard security measures to protect against unauthorized access, alteration, disclosure, or destruction.
We do not use cookies or tracking technologies on our website.
Our website may contain links to third-party websites for your convenience. Please note that we have no control over and are not responsible for the content or privacy practices of those websites.
Under data protection law, you have rights including:
You are not required to pay any charge for exercising your rights. If you make a request, we have one month to respond to you. If you wish to access, correct, or delete any personal information we hold about you, please contact us using the contact information provided below.
If you have any questions or concerns about our privacy policy or the data we may hold about you, please contact us at: london@osi-company.com or using the contact form on our website.
We may update our privacy policy from time to time to reflect changes in our practices or for other operational, legal, or regulatory reasons. Any changes will be posted on this page.
This privacy policy is intended to comply with UK data protection and privacy laws, and it covers data related to our prospective and existing client contacts, employees, supplier contacts and contract workers necessary for carrying out our business.
If you have any concerns about our use of your personal information, you can make a complaint to us at london@osi-company.com or using the contact form on our website.
You can also complain to the ICO if you are unhappy with how we have used your data.
Information Commissioner's Office
Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF
Helpline: 0303 123 1113
Website: www.ico.org.uk
Systematic review of qualitative research outputs and verbatim responses for adverse event disclosures — keeping your pharmaceutical research compliant with BHBIA, EPhMRA, and global pharmacovigilance obligations.
When pharmaceutical and healthcare companies conduct market research — whether through surveys, in-depth interviews, focus groups, or online communities — participants may spontaneously disclose adverse events. Under BHBIA and EPhMRA guidelines, and broader pharmacovigilance obligations, these disclosures must be identified, documented, and reported within defined timeframes.
The challenge is compounded when research is conducted across multiple languages. An adverse event disclosure made in German, Mandarin, or Portuguese must be identified with the same rigour as one made in English — which requires specialist linguists who understand both the language and the clinical significance of what is being said.
Our commitment: Every adverse event check is conducted by linguists with training in pharmacovigilance terminology and industry guidelines. We don't just flag keywords — we apply clinical context to distinguish genuine AE disclosures from general discussion of a condition or treatment.
Our adverse events checking service is conducted in accordance with BHBIA and EPhMRA guidelines for the conduct of pharmaceutical market research. We apply the four-criteria framework for AE identification — an identifiable patient, an identifiable reporter, a suspect product, and an adverse event — to every piece of content we review.
We review research outputs in their original language, rather than relying on translated summaries. This ensures that nuance, ambiguity, and implicit AE disclosures are not lost before checking begins. Our linguists are native speakers with subject-matter knowledge of pharmaceutical and clinical terminology in their target language.
For qualitative research conducted via interview or focus group, we offer direct review of audio and video recordings — identifying AE disclosures that may not be captured in a transcript, or where tone and context are relevant to the assessment. This is particularly valuable where verbatim transcription has not been commissioned.
All identified adverse events are documented in a structured report, including source material reference, verbatim disclosure, language of origin, and our four-criteria assessment. Reports are formatted for straightforward handover to your pharmacovigilance, medical affairs, or project management team.
Systematic AE checking of multinational surveys and qualitative studies involving patients, caregivers, or healthcare professionals discussing treatments and experiences.
Direct review of IDI and focus group transcripts or recordings across multiple languages for spontaneous AE disclosures requiring follow-up and reporting.
Structured review of open-ended survey responses across large multilingual fieldwork datasets to identify AE disclosures before data is closed.
Ongoing monitoring of patient or HCP online research community content for adverse event disclosures requiring pharmacovigilance action within required timeframes.
Our service is designed to support compliance with the following guidelines and obligations:
Our specialist team supports adverse events checking across languages, formats, and research methodologies.
Talk to Our TeamRigorous, multi-stage linguistic validation of COAs, PROs, and patient-facing instruments — following FDA, EMA, and ISPOR standards to deliver regulatory-grade documentation in any language.
Translation alone is not sufficient for clinical outcome assessments. A PRO instrument that has been linguistically validated has gone through a structured, documented process to ensure it is not just accurately translated, but conceptually equivalent, culturally appropriate, and capable of measuring what it was designed to measure in the target population.
Regulatory agencies — including the FDA and EMA — require evidence of linguistic validation for COAs used in support of labelling claims and regulatory submissions. ISPOR task force recommendations provide the methodological framework that sponsors, CROs, and outcomes research teams rely on to meet this standard.
Regulatory-ready from day one: Every OSI Linguistic Validation project produces a full methodology report and audit trail — formatted to meet FDA, EMA, and ICH requirements and ready for inclusion in a regulatory submission package.
We provide Linguistic Validation services across all categories of Clinical Outcome Assessment:
Two independent translators — each a native speaker of the target language with relevant clinical or patient-experience expertise — produce separate forward translations of the source instrument. Translators work independently to preserve differences in interpretation that inform the reconciliation stage.
A reconciliation meeting brings together the two forward translations under the guidance of an experienced project manager. Discrepancies are reviewed, discussed, and resolved to produce a single reconciled translation. All decisions are documented with rationale for the audit trail.
An independent translator — native speaker of the source language with no prior exposure to the original instrument — translates the reconciled version back into the source language. The back-translation is reviewed against the original to identify any conceptual shifts or inaccuracies introduced during forward translation.
Where validated versions of the instrument exist in other languages, we conduct a cross-language harmonisation review to ensure consistency in approach and terminology across the language portfolio. This is particularly important for instruments deployed in multi-country clinical trials.
The reconciled translation is tested with a sample of target-population participants — typically patients, caregivers, or clinicians — through structured cognitive debriefing interviews. Participants are asked to describe their understanding of each item in their own words, identifying any that are unclear, ambiguous, or culturally inappropriate. Findings are documented and fed back into a final review.
Clinical and linguistic experts review the instrument in light of cognitive debriefing findings, approving final wording and documenting any amendments. The validated instrument is finalised with a complete methodology report covering all stages, decisions, and participant data.
Our Linguistic Validation experience spans a broad range of therapeutic areas and instrument types:
HRQoL instruments, symptom burden measures, and functional assessments for cancer patients across disease stages and treatment settings.
Validation of instruments for small, geographically dispersed patient populations — with experience navigating the recruitment challenges of cognitive debriefing in rare disease.
Cognitive and functional performance assessments, clinician rating scales, and patient self-report instruments for neurological and psychiatric conditions.
Symptom diaries, daily diary instruments, and HRQoL measures for respiratory, allergic, and autoimmune conditions.
From a single language to a global portfolio — our structured LV process delivers the documentation regulators require.
Start Your Validation Project