Linguistic validation in clinical trials
Each treatment procedure, regardless of whether it is standard or conducted as part of a clinical trial, involves certain risks. Translation of patient materials must undergo one of the most rigorous translation processes to ensure that all content is properly understood and interpreted in the same way in every language and culture. We carry out linguistic validation of clinical documentation intended for patients at every stage of a clinical trial: from information on the detailed course of treatment and possible consequences (ICF) to descriptions reflecting the well-being of patients participating in the study (COA and PRO). Thanks to linguistic validation and cultural adaptation, we ensure the highest quality translated texts that guarantee effective communication with study participants. At Omero, we provide an individual approach to each translation project. Our experience allows us to adapt the process of the linguistic validation process to the needs of our customers. The two stages of the linguistic validation process – harmonization and reconciliation – may occur in the form of an Expert Committee. This is a meeting during which independent experts share their diverse knowledge in order to approve, together with translators, one, the most precise version of translation. We provide organization and supervision over the course of such an online meeting. Consult our advisor and find out how we can adapt the linguistic validation process to the needs of your translation project.