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Practical articles on translation quality, AI in regulated content, terminology and market entry, written by the linguists and project leads who do the work.
The language is the same, and the geographic market is the same, but there are different cultural contexts and emotional triggers involved. This wasn’t a translation problem.
A Phase 2 plain language results summary must be accessible to a patient with no science background and precise enough for ANSM review – in French, finding the register that achieves both takes more than simplification.
A 40-page Phase 3 ICF contained a legally precise consent form and an accessible patient summary, alternating section by section. Translating both into French for ANSM and FAMHP without one register bleeding into the other.
By version 9 of an open-label extension ICF, a single terminology change ripples back through every previous French version – unless a documented term record has been maintained from the start.