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

Introduction As SEND becomes more established in regulatory submissions to the U.S. FDA, expectations are evolving beyond basic dataset standardization toward greater transparency, expanded domain coverage, and improved support for regulatory review. With SENDIG v4.0 expected to be published in 2026, organizations preparing nonclinical submissions will need to adapt to a broader and more detailed set of requirements. These updates go beyond incremental changes and are likely