SEND continues to evolve as regulatory expectations grow and nonclinical research becomes more complex. With SEND 4.0, organizations will face major updates, including new immunology, dermal, ocular, and pathology‑focused domains, as well as structural changes such as the new Non‑Standard Variables domain. These enhancements aim to improve clarity, consistency, and scientific alignment across studies, but they also require early planning and system readiness.
In this white paper, Instem experts break down the anticipated SEND 4.0 updates and what they mean for study design, data collection, and submission workflows. You’ll gain insight into new and revised domains, expanded scientific coverage, and the expected roadmap from public review through future FDA requirement. The paper also highlights practical steps organizations can take now to assess their current processes, strengthen data quality, and ensure partners and internal teams are prepared for the transition.
You’ll also learn how Instem’s Submit™ platform helps organizations stay ahead of continuous SEND change through automated standard alignment, modular workflows, and expert support that reduces compliance risk and accelerates readiness.
Complete the form to download the full white paper and begin preparing your organization for SEND 4.0.
