Linguistic validation
Linguistic validation – essential in clinical trials
Every research procedure involving health risks requires clear and comprehensible communication with study participants – regardless of language. Linguistic Validation (LV) is a rigorous translation process ensuring that patient-facing documents are unambiguous, understandable, and culturally adapted. This eliminates potential misunderstandings and increases the reliability of collected data. At Omero, we make sure every stage of the process is tailored to project needs and ethical requirements.
Examples of documents requiring translation
- Patient-reported outcomes (PRO)
- Questionnaires
- Clinical outcome assessments (COA)
- Informed consent forms (ICF)
How does the Linguistic Validation process work?
The LV process begins with the translation of the source document, followed by harmonisation, reconciliation, cognitive debriefing (comprehension testing), and final verification. At key stages, we may organise an Expert Committee meeting, bringing together independent experts and translators to agree on the most accurate version. This structured process eliminates ambiguities and ensures maximum precision – particularly vital for documents intended for clinical trial participants.
Key benefits of Linguistic Validation
The process of linguistic validation ensures that documents are fully comprehensible to patients, linguistically accurate, and culturally appropriate, which in turn guarantees the precision and reliability of the clinical data collected. It also secures compliance with regulatory and ethical requirements, significantly reducing the risk of results being questioned or rejected by ethics committees. By minimising errors and delays, it helps researchers and sponsors save both time and resources while maintaining the highest quality standards. Each stage of the process is transparent and carefully documented, with detailed reporting of all adaptations and changes introduced, providing complete confidence in the final outcome.
Our experience
We collaborate with international pharmaceutical companies, research centres, and CROs, delivering top-quality linguistic validation. Each project is handled individually, with the process tailored to the study’s requirements and target language. We also provide expert support in communication with regulatory authorities.
Case study: cultural adaptation and linguistic validation
Challenge:
We were invited by one of the largest research centres at Nicolaus Copernicus University in Toruń to validate a questionnaire developed in parallel in English and Swedish. Our task was to prepare the Polish version.
Solution:
We applied the full cultural adaptation process – Linguistic Validation – based on the English version. This included initial translation, expert consultations, harmonisation, cognitive testing, and finalisation of the document.
Results:
Pilot studies
The questionnaire passed pilot testing successfully.
Improved research outcome
Validation increased study efficiency by 90%.
Time and cost savings
The refined instrument helped the client save resources and accelerate the project.
When and why to use LV
Multiple target groups
When a single research problem involves participants from different backgrounds.
Varied knowledge levels
When patients have different levels of general knowledge, texts must remain equally clear to all.
Precision matters
The more accurate the validation, the more reliable the study data.
Adaptation to local markets
In international studies, language and cultural adaptation is essential for patient materials.
Tailored to the medical market
The growth of the medical sector depends heavily on the number and quality of clinical studies – where the patient’s voice is critical, even at early stages. The same research tools are often applied to patient groups in different countries. To ensure meaningful results, content must be translated with contextual and subject-matter accuracy, while also being linguistically and stylistically adapted.
Simple translation is rarely sufficient. Documents must be adjusted to the specific characteristics of the target audience, their cultural norms, and social context to avoid misinterpretation.
For example, patients may report pain differently depending on cultural background. While a numeric pain scale is useful, asking how pain affects daily activities provides deeper insights – and such questions must be culturally adapted to ensure relevance.
The LV process involves specialist translators and independent subject-matter experts, working together to ensure that questions are properly phrased and responses are reliable. Correctly prepared patient-facing documents produce precise, high-value data for researchers.
Do you need linguistic validation?
Consult your project with our expert.