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Translation and linguistic validation

The methodology we apply to the translation (or review) and linguistic validation of a COA, especially Patient Reported Outcome (PRO) measures (or PROMs), is among the most robust in the field of translation services.

The InSpired Health Outcomes team and the highly experienced and trusted associates we work with have managed thousands of projects translating and linguistically validating COAs, in over 200 languages and across diverse conditions / therapeutic areas.

The target conditions for the COAs we have translated and linguistically validated (involving suitable patient populations) have included rare and / or childhood diseases, neurodegenerative, oncology, musculoskeletal, cardiovascular and endocrine conditions, to name just a few.

More detail of the methodology used to ensure an accurate and faithful translation and linguistic validation of COAs can be seen here.

Linguistic validation methodology ISPOR FDA

InSpired Health Outcomes Linguistic Validation methodology complies with the guidance of the U.S. Food and Drug Administration (FDA) and the good practice recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on the subject of faithfully translating, culturally adapting and linguistically validating Clinical Outcomes Assessments (COAs).

Whenever we undertake a translation and linguistic validation of one of our own (or somebody else’s) COA the key aim is to ensure that the resulting version is accurate and faithful to the original. Only through the stringent application of such a robust methodology can all stakeholders (author / owner, user, sponsor and ourselves) be confident that the measurement properties of the questionnaire are retained.

Once a new version is created it is introduced into our library of available translations / cultural adaptions. At IHO, we manage easy access to this repository of localised versions, supporting the use of only properly translated versions. Each translation is accompanied by a documented detailed record of the method applied in each translation.

Through this process we deliver ready access to a library of the highest quality translations (and cultural adaptions) of COAs for their application in international research.

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Other Core Services

As part of our COA management services we oversee the supply of authorised, translated COAs (which we have available for licence), complete with letters of certification, which adhere to sector good practice. We are also able to undertake the translation and linguistic validation of COAs presented to us by clients and are a recognised supplier of such services to third party COA owners / users.

To talk to us about the translation and linguistic validation of COAs, please get in touch.

Management and licensing of Clinical Outcome Assessments

At InSpired Health Outcomes, we have a wealth of experience in managing, promoting and supporting the use of COAs.

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Specialist Services

The team at InSpired Health Outcomes can provide a broad spectrum of specialist COA expertise in the design, development and use of COAs.

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