Linguistic Validation
Linguistic Validation Services
Linguistic validation is vital for the integrity of clinical trials, ensuring Clinical Outcome Assessment (COA) instruments are accurately translated and validated across multiple languages and cultures. Our meticulous process prioritises precision, conceptual equivalency, cultural appropriateness, and regulatory compliance to ensure that your clinical data maintains validity, reliability, and comparability across global studies.
We perform translatability assessments and concept elaboration to identify and resolve potential linguistic or cultural issues proactively. Our team adheres strictly to the latest ISPOR, ISOQOL, FDA, and EMA guidelines and best practices, guaranteeing robust and defensible translations.
Our comprehensive linguistic validation workflow includes:
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1. Conceptual Analysis (Translatability Assessment and Concept Elaboration)
We prepare detailed analyses to ensure clarity, linguistic accuracy, and cultural suitability of concepts across target languages, setting the stage for seamless translations.
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2. Two Forward Translations
Performed independently by two in-country expert linguists experienced in clinical trial and life science translations.
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3. Reconciliation
An experienced in-country linguistic validation consultant reconciles both translations, creating a unified, culturally sensitive, and conceptually accurate version.
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4. Back Translation
A new translator translates the reconciled version back into the original language to identify discrepancies and validate conceptual equivalence.
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5. Back Translation Review
The back translation is thoroughly reviewed against the original text, discrepancies are analyzed, and necessary adjustments are implemented to ensure conceptual fidelity.
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6. Proofreading and External Review
The translations are rigorously proofread by the in-country linguistic validation consultant and an independent in-country expert linguist, enhancing accuracy, readability, and quality.
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7. Developer/Clinician Review
We collaborate directly with the instrument developer and expert clinicians to review translations, further ensuring clinical accuracy and conceptual integrity.
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8. Cognitive Debriefing
Native-speaking in-country linguistic validation consultants recruit local patients and clinicians of your target populations. Cognitive debriefing interviews verify patient understanding, confirm conceptual equivalency, and ensure translations are culturally relevant and appropriate.
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9. Proofreading (Post-debriefing)
After incorporating feedback from cognitive debriefing, we conduct another round of proofreading, further solidifying the accuracy and integrity of the translation.
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10. Final Report and LV Certification
We deliver comprehensive linguistic validation reports and official certification documents, clearly outlining all processes and decisions for full regulatory transparency.
Why Work with Us?
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Native-speaking Expertise:
We work exclusively with in-country translators and in-country linguistic validation consultants, who recruit local patients and clinicians in the target language countries, ensuring authentic cultural insight.
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Guideline Compliance:
Our linguistic validation methodologies fully comply with the latest ISPOR, ISOQOL, FDA, and EMA guidelines, maintaining regulatory rigorous.
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Robust and Accurate Data:
Our processes guarantee that your translated COAs maintain conceptual equivalency and cultural appropriateness, thus preserving the validity, reliability, and comparability of your clinical data across regions.
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Comprehensive Collaboration:
We closely collaborate with your electronic Clinical Outcome Assessment (eCOA) provider and all relevant parties to ensure smooth alignment with required regulatory timelines and standards.
What Our Clients Say
Trusted for Clinical Trial Translations
We partnered with NN Translations to translate extensive clinical study documents for research programs of our Group across several Eastern European countries, including Bulgaria, the Czech Republic, Poland, Slovakia, Slovenia, Hungary, and Serbia. As a client based in China, we required precise and culturally sensitive translations for engaging participants and conducting vital research. NN Translations delivered exceptional service and quality, which proved crucial in navigating the complexities of these markets and supporting us to conduct clinical trials in these countries. We highly recommend NN Translations for their unparalleled professionalism and expertise.
Leading Clinical Research Organization in China
Efficient and Reliable Project Management
We needed a trusted partner to handle complex multilingual projects across Europe. NN Translations provided seamless coordination, ensuring regulatory compliance and meeting tight deadlines. Their expertise in linguistic validation and translation has been invaluable to our research.
Senior Project Manager
High-Quality Translation & Validation Services
NN Translations consistently delivers accurate and regulatory-compliant translations. Their linguistic validation services have helped us improve patient-reported outcomes in multiple languages. We trust their team for precision and efficiency.
Clinical Operations Lead
A One-Stop Solution for Life Science Translations
We work with NN Translations because they understand the complexity of our industry. Their ability to manage large-scale projects in multiple languages has made them a key partner in our global trials.
Regulatory Affairs Manager
Key Benefits of Linguistic Validation:
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Content Validity:
Ensures that your COA instruments measure exactly the same constructs across languages, providing reliable data.
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Conceptual Equivalence:
Linguistic validation guarantees translated instruments maintain the original concepts and intended meanings.
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Data Accuracy and Comparability:
Reliable translations allow for accurate pooling and comparison of data collected from various global locations.
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Comprehensive Collaboration:
We closely collaborate with your electronic Clinical Outcome Assessment (eCOA) provider and all relevant parties to ensure smooth alignment with required regulatory timelines and standards.
By investing in high-quality linguistic validation, you significantly enhance your clinical trial outcomes, patient engagement, and regulatory compliance, ultimately driving the success and credibility of your global clinical research.
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