Introduction As SENDIG v4.0 continues to shape planning discussions for 2026 submissions, many sponsors and CROs are rethinking how they approach SEND readiness. The focus is no longer only on converting data at the end of a study. It is now about building a process that supports clean, traceable, and submission-ready data from the beginning. That shift is important because SEND readiness is not just a technical task. It connects study design, source data quality, mapping dec