We recommend LV when translating

the following documents

clinical outcome assessment (COA)
patient-reported outcomes (PRO)
patient informed consent forms (ICF)

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.

The most important benefits of using the LV process

The linguistic validation process ensures that the translated documents are adapted to study participants, culturally appropriate and linguistically correct. As a result, investigators and clinicians can be sure that the data they receive are accurate and reliable. This minimizes the risk of the Bioethics Committee questioning or invalidating the study results and to avoid the associated financial losses. The selection of an appropriate team of translators contributes to the highest quality of translations of the data collected during the study. At Omero, we deliver accurate, on-time translations that contribute to the success of our clients from the pharmaceutical and clinical study industry. The use of the Linguistic Validation process allows precise quality control and monitoring of changes introduced in the translation at individual stages of the process, which are included in the final LV report.

See the case study of one of our customers