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What Is Linguistic Translation Validation?

When marketing a new medical device or putting a new drug on the market or in other situations where a patient’s health is at stake, companies in the life sciences sector must use scientific techniques when translating content to ensure it has the same meaning as the original.

Clinical outcome assessments, and especially patient-reported outcomes are documents that are vital in determining whether a device or medication is allowed onto the market. They provide important information that can impact the validity of a clinical trial and thus must undergo a rigorous translation process referred to as linguistic validation.

Linguist validation translation refers to a process where the translated text is actively tested by a linguist through clinician review and cognitive debriefing for the target audience to ensure that the translated documents are conceptually the same as the original and linguistically accurate so that no meanings or concepts change as part of the translation process.