Linguistic Validation

Linguistic validation and readability tests are used with medical texts that are patient-facing. If these checks need to be applied to multiple languages and in multiple countries, project management needs to be very tight. Wilkens c.s. Medical Translations will manage this project for you in its entirety.

Linguistic Validation

Wilkens c.s. Medical Translations collaborates with a partner specialising in linguistic validation of package leaflets and questionnaires. Our partner has a specialised team of researchers in a great number of countries. The researchers engage doctors in these countries to check the language and content of the translation. They also test the readability of the translation with the help of study subjects from the patient audiences in the target country. Depending on the findings, the translated texts can be adapted as needed.

Readability tests

European regulations require the submission of package leaflets for new medicinal products to consumer panels in one language. The readability test of a package leaflet checks whether the information can be easily found, understood and applied. Test outcomes could suggest further improvements to a package leaflet.

Readability tests are a mandatory aspect of the authorisation procedure, and the outcomes are added to the authorisation dossier. Wilkens c.s. Medical Translations tests package leaflets according to a fixed procedure based on European Commission guidelines.