Can your patient questionnaire survive translation?
A poorly adapted Clinical Outcome Assessment (COA) can compromise patient understanding and affect the quality of your study data. Atlas Translations provides specialist linguistic validation services to help ensure your COAs work as intended, wherever your trial takes place.
Linguistic Validation for Clinical Outcome Assessments
Helping your patient questionnaires speak every language.
In international clinical trials, a straightforward translation isn’t enough. Patient-reported outcome measures (PROs), clinician-reported outcomes (ClinROs) and other Clinical Outcome Assessments (COAs) need to measure exactly the same concept across different languages and cultures.
Atlas Translations offers linguistic validation services to help maintain the accuracy, reliability and integrity of your clinical research.
What is linguistic validation?
Linguistic validation is a structured process used to adapt Clinical Outcome Assessments (COAs) for use in different languages and cultures. The aim is to ensure that each version measures the same concepts as the original, allowing data to be compared confidently across international studies.
It’s about much more than translation. It involves careful review, quality assurance and testing to ensure that questions are understood in the way they were intended.
For example:
“Have you felt blue?”
A direct translation may refer to a colour rather than a mood in another language. Linguistic validation ensures that the meaning, rather than simply the words, is preserved.
Our process
Atlas can support every stage of the linguistic validation process, including:
- Initial translation
Performed by specialist medical translators with experience in clinical research and patient-facing materials.
- Independent review
A second linguist checks the translation for accuracy, consistency and cultural appropriateness.
- Reconciliation
Alternative versions are compared and harmonised to produce the most appropriate wording.
- Back translation
Where required, an independent translator translates the text back into the source language to identify any conceptual differences.
- Expert review
Medical and linguistic specialists examine the translation to ensure scientific and clinical accuracy.
- Cognitive debriefing
Testing with native speakers from the target patient population to confirm that the questionnaire is clear and easily understood. (We don’t arrange the community review with the patients on our side, but we liaise with the client, review their findings and implement any changes to the translation afterwards).
- Final proofreading and quality assurance
A comprehensive final review before delivery.
What can be validated?
We regularly receive enquiries relating to:
- Patient Reported Outcome Measures (PROs)
- Observer Reported Outcomes (ObsROs)
- Clinician Reported Outcomes (ClinROs)
- Performance Outcome Measures (PerfOs)
- Quality of life questionnaires
- Patient diaries
- ePRO platforms
- Symptom trackers
- Screening questionnaires
- Health economics and outcomes research (HEOR) materials
- Clinical trial documentation
Why choose Atlas?
Medical expertise
We’ve worked with healthcare, pharmaceutical and life sciences organisations for many years, handling sensitive and highly technical content.
Global network
Our carefully selected specialist linguists combine medical knowledge with native-level language expertise.
Quality-focused
Our ISO-certified processes help ensure consistency, confidentiality and rigorous quality control.
Flexible approach
Whether you need a straightforward validated translation or support for a larger multinational study, we can tailor our services to your requirements.
Who do we work with?
We support:
- Pharmaceutical companies
- Biotechnology companies
- CROs
- Medical device manufacturers
- Universities
- Research organisations
- NHS and healthcare providers
- Health charities
Frequently Asked Questions
Isn’t this just medical translation?
Not quite.
Medical translation focuses on accurately translating medical information. Linguistic validation goes further, ensuring that questionnaires and assessment tools are culturally appropriate and conceptually equivalent so that data collected across different countries can be reliably compared.
Planning an international clinical study?
Whether you need a single validated questionnaire or multilingual support across an entire clinical programme, Atlas Translations can help.
Get in touch to discuss your linguistic validation and Clinical Outcome Assessment requirements.