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Translation & Linguistic Validation

Language services across international clinical research and care settings

Helping patients easily and accurately understand every linguistic component of multinational studies, projects and programs

Through our trusted network of U.S.-based linguists and in-country translators, we deliver cross-cultural adaptations and linguistically validated translations of all types of clinical and scientific content. Our specialists cover more than 200 languages across research locations around the world. Working towards absolute conceptual equivalence, cultural appropriateness and content validity, we enable each target population to interpret translated items exactly as intended.

 

Our translators are not only selected for their linguistic expertise, but also for their breadth of knowledge on end-to-end drug development and country-specific guidelines. Closely following FDA and ISPOR recommended methodology, we align your PRO translations with both regulatory authority requirements and industry best practices in the clinical research space.

Specialized Areas

Study Documents & Materials

Manuals
Protocols
CRFs
Consent Forms
Interview Scripts
Metatext

Translatability Assessment

In the early stages of PRO development, a translatability assessment can help you determine the suitability of the proposed language. Our process involves the designation of “difficulty ratings” that allow you to easily identify and address any problematic items. We then present our findings and recommendations in a comprehensive report.

Our Standard Process

1
Multiple forward
translations

We gather translations from multiple consultants who are native speakers of the target language and bilingual in English. Emphasis is placed on conceptual rather literal equivalence and achieving an appropriate reading level.

2
Consolidation

Independent forward translations are reconciled into one preliminary form.

3
Back translation &
evaluation

This form is translated back into English and evaluated by U.S. researchers and in-house project managers for conceptual equivalence with the original survey.

4
Clinician review (if
needed)

A clinician review is included for selected instruments to ensure culturally appropriate translation of items containing treatment names and other jargon. Clinician(s) residing in the target country will provide input on the clarity and accuracy of the translation.

5
Cognitive debriefing

Cognitive debriefing interviews are conducted among a sample of native speakers of the target language living in-country to determine clarity, common language usage and conceptual equivalence.

6
International
harmonization

An international harmonization meeting is attended by linguists who are representative of each target language and country. Linguists will be asked to review the existing translation and update any item to ensure conceptual equivalence and consistency across all translations of the same instrument included in the project.

7
Final quality check

The final translation is proofread by native speakers and formatted for quality assurance.