Conceptual equivalence and international harmonization for global trials
When conducting global clinical trials, questionnaires are often only available in English. As good data management is integral to clinical outcome assessments (COAs), it is imperative that the participants clearly understand the instruments being employed.
Linguistic validation ensures that global participants conceptually and equivalently comprehend the translated instruments in all languages, allowing for a single statistical analysis of combined multinational data.
Our multi-step ISPOR-compliant methodology involves phases of assessment, translation, harmonization and cognitive debriefing to ensure conceptual equivalence and international harmonization.