SEND v4.0 is the most significant expansion of the standard since version 3.0, introducing new domains, study types, controlled terminology, and new approaches to representing familiar data. The instinct for many organizations is to treat readiness as a downstream task, waiting for the final implementation guide before building mapping rules. Evidence from across the industry points the other way.
In this white paper, Instem experts Marc Ellison and Alice Ashcroft draw on the contributions of more than 70 participants from pharmaceutical sponsors and CROs, including SEND specialists, study directors, pathologists, data managers, and safety pharmacologists. Across every session, the same message emerged: clean SEND v4.0 output depends on how data is captured at source, long before a mapping rule is ever written.
The paper examines the hidden cost of today’s workarounds, from data held in comment fields and spreadsheets to information force-fitted into existing domains, and why these approaches won’t scale to the volume, structure, and traceability that SEND v4.0 requires. You’ll learn why the capture-versus-representation gap is the central challenge, where required data exists in organizations today but not in a form the standard can consume, and what it takes to close that gap upstream.
The paper also explores the cross-functional dimension of readiness, showing why SEND v4.0 preparation cannot be handed to a single function and must involve alignment across pathology, safety pharmacology, data management, and SEND teams. Practical guidance is provided for organizations at every stage of readiness, from initial scoping to prioritizing high-risk gaps and establishing controlled workarounds where collection changes are not immediately feasible.
Complete the form to download the full white paper and learn how to build a practical, upstream approach to SEND v4.0 readiness before the standard becomes mandatory.
