SEND v4.0 is the most significant expansion of the standard since version 3.0, adding new domains, study types, controlled terminology, and new approaches to representing familiar data. For many organizations, the instinct is to treat readiness as a downstream task, waiting for the final implementation guide before taking action. The findings from Instem’s 2026 domain workshop series suggest that instinct carries real risk.
Over the course of 2026, Instem’s regulatory experts hosted a series of four SEND v4.0 domain workshops covering microscopic findings, immunogenicity and cell phenotyping, nervous system findings, and skin test results. Drawing on input from more than 70 participants across pharmaceutical sponsors and CROs, including study directors, pathologists, data managers, safety pharmacologists, and SEND specialists, a consistent message emerged: clean SEND v4.0 output depends on how data is captured at source, long before a mapping rule is written.
In this webinar, the team who led those workshops share what they heard, what the collective findings mean, and what preparation should look like now rather than later. Topics covered include:
- Why SEND v4.0 readiness begins at the point of capture, not at mapping
- The hidden cost of workarounds, from comment fields and spreadsheets to force-fitted domains
- Capture gaps across scoring scales, negative correlations, skin irritation scoring, and phenotyping metadata
- Why readiness reaches across pathology, safety, data management, and SEND teams
Complete the form to access this recording and discover what your organization needs to do now to get ahead of SEND v4.0:
