Linguistic Validation Division

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CogentPlus, Inc. (COGENTPLUS) has created a specialized business unit dedicated to providing superior linguistic validation (LV) services. The expert team at COGENTPLUS understands the complexity of the human mind, emotions, feelings and quality of life. Our highly trained linguists are professionals and subject-matter experts in numerous therapeutic fields, and have a vast knowledge of LV procedures and rigorous methodology. Our management team has considerable experience in the areas of psychology, public health, psychometrics, cognitive debriefing, and cultural/linguistic diversity, and this ensures a competent coordination of multi-language/multi-instrument projects.

Reliable Data from Reliable Translations

The need for the pharmaceutical industry to gather accurate, reliable data from global clinical trials has increased exponentially in the past several years. The process of translating or culturally adapting Patient Report Outcomes measures (PROs) is progressively regulated and vital to yielding statistically meaningful (and reliable) data.

Our LV Team is cognizant of the importance of accuracy and conceptual equivalence, and our methodology has integrated numerous quality checks throughout the process to ensure just that.

Your Questions – at the Patient’s Reach

Patient research regulatory authorities require that any questionnaires to be completed by the patient be written in the patient’s native language. The level of comprehension must be such that all concepts are understood by the average native subject. It is also vital that the translations convey exactly the same concept as the original questionnaire, and that these concepts are consistent for all languages in a specific protocol.

COGENTPLUS’ LV Team ensures that conceptual equivalency is achieved. We also make sure that the questionnaire developers are consulted and can provide, should the client request it, independent clinical review of every translation.

Why choose COGENTPLUS?

Expert consultation services and research: Our Project Coordination team will work with your study management and Outcomes Research team to customize every project to your protocol needs. We can offer advice on questionnaire development and selection, potential translation issues (assessment of original questionnaire), liaison with developers and copyright holders, and securing license agreements.

Quality: Our translations are accurate, culturally-adapted and conceptually equivalent to the original and all other languages.

Speed: COGENTPLUS’ experienced LV-team can produce expedited translations without compromising the final product. Our account managers will work with you on your timelines to ensure validated, approved documentation for your First Patient First Visit (FPFV) to be successful in every study site.

   Services

  • Initial consultation on questionnaire development, selection and modification
    • Advice on developing new questionnaires and/or modification of validated measures; identifying country sites and advising on languages needed at each site.
  • Liaison with copyright holders and developers – securing license agreements
    • Research on existing validated versions and obtaining them on behalf of the client; contact with developers/copyright holders; execution of license/permission to use agreements; ensuring new translations’ procedures’ compliance, if any.
  • Source document analysis to detect potential translation and cultural issues
    • Original questionnaire is analyzed for consistency of terminology, cohesiveness between questions and response sets, and readability. Other areas covered in this pre-translation assessment are:
    • Terminology is appropriate for the target population
    • Conceptual guide for translation teams
    • Idioms and expressions in original document are analyzed for translatability and potential adaptation problems.
  • Harmonization
    • Two independent forward translations; one harmonized translation; one back translation; reconciliation and expert review of harmonization and back translation.
  • Clinician and /or developer review
    • Back translation is reviewed by developer, if available. Harmonized translation is sent for in-country review (a clinician or site manager). Analysis of reviewer comments by linguistic team.
  • Cognitive debriefing
    • Pilot-testing of the approved harmonized translation in the target country, with native speakers of the target language, through cognitive interviews and analysis.
  • LV report
    • Deliverables: A report documenting the methodology, interview results and subsequent analysis, as well as the finalized validated translation(s) and certification of methods.
  • Desktop publishing
    • The validated translation will be provided in the sponsor’s requested format, including any of their proprietary templates and CRF formats.
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“Language is not just words. It’s a culture, a tradition, a unification of a community.”

-Noam Chomsky

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