Our Translation/ Review and Linguistic Validation process conforms to the clinical outcome assessments translation and linguistic validation methodology recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and approved by regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Such methodology is meant to ensure conceptual equivalence to the original (normally validated) source file and clear understanding of the questions by a population of the intended target respondents in a real-life scenario.

The linguistic validation process includes the following steps:

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Clinical Outcomes at Oxford University Innovation offer (and encourage) the integration of a Translatability Assessment stage during the development of new patient, clinician and observer reported outcomes. The aim of a translatability assessment is to identify aspects of a measure which might lead to difficulties in replicating words or concepts in other languages. Recognising potential cultural, linguistic, and visual issues during COAs development will allow you to optimise the original wording of the instrument and minimise the efforts during translation so better enabling the collection of accurate and equivalent data in multi-country studies.

Translatability assessment includes the following steps:

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Should the language required for your study not be available from our library, or not fully validated yet, we offer Linguistic Validation services to fulfil your language requirements. We can provide Translation and Linguistic Validation Services for our own COA portfolio and COA instruments owned by others. We avail ourselves of experienced, well-known and highly regarded associates to deliver this service, with the oversight of a dedicated member of staff at Clinical Outcomes. Our Translation Project Coordinator will follow your project from initial quotation, through regular weekly updates reporting progress, to the delivery of the final formatted translation and will assist you with any questions you have.

Your translation request will be constantly monitored and detailed with regular sharing of your status reports showing the development of your commissioned translations.

At completion of the project, you will receive a fully validated and formatted COA translation accompanied by a Certificate of Translation issued and signed by OUI. The Certificate of Translation will contain information on all the steps followed by the linguists and also provide information on the patient population that has been used to test the new translation.

If you are interested in commissioning Linguistic Validation services, please contact us to discuss an initial quote. With our focus on quality and customer service, we provide transparency, timely delivery, and accuracy along all the steps of the project.

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Certified translations have been created and tested strictly in accordance with industry good practices by Clinical Outcomes or other recognised translation company and come with a Certificate of Translation confirming methodology used (which includes as a minimum Dual Forward and Dual Back Translation plus Cognitive Debriefing). Non-certified translations may still be of very high quality and follow good practices, but do not come with official certificates of translation, only letters stating the methodology used for their translation.

More information can be found here: Certified and Non-Certified Translations difference

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