SEND v4.0 represents one of the most significant changes to the Standard for Exchange of Nonclinical Data (SEND) in years. In the recent webinar, “SEND v4.0 Readiness Starts at Data Collection”, Instem’s Marc Ellison, Director of Product – Regulatory Solutions, and Dr Alice Ashcroft, Product Researcher, shared findings from four 2026 SEND workshops covering microscopic findings, immunogenicity and cell phenotyping, nervous system findings and skin testing results.
The session, held on 15th September 2026, involved more than 70 participants including SEND specialists, pathologists, and system administrators. Participants engaged in providing feedback and insight on SEND v.40. This webinar recap explores the main findings from the webinar, and reflects on how sponsors and CROs should prepare for SEND v4.0 going forward.
Finding #1: The Work is Upstream
Participants of the SEND workshops were asked “What will require the most effort for SEND v4.0?”. A consistent theme among the feedback was that SEND v4.0 readiness will begin with data collection.
In the nervous system workshop, nine of 12 participants ranked data collection as the area they expected to require the most effort. This was ranked above mapping rules, instrument integration, quality control, and validation.
The reason behind this is that SEND v4.0 introduces requirements for information that may not currently exist within a usable format. If context is not captured appropriately when a study is performed, a mapping rule cannot reliably recreate it later. Thus, there needs to be an intrinsic shift in submission preparation regarding how data is generated, captured, and governed.
Finding #2: The Workarounds of Today May Not Scale
A second finding from the workshop was that of regulatory exposure. Many existing workflows depend on manual workarounds. Participants described targeted staining data being managed through Excel, immunogenicity data being force-fitted into existing structures, skin irritation scoring being placed within clinical observations, and microscopic findings that rely on result modifiers. While such approaches may meet operational needs, these practices introduce repeated manual effort and inconsistency, and ultimately will be exposed by the SEND v4.0 update.
It is evident that with SEND v4.0, organizations could face greater downstream fixes, additional quality control, and increased reliance on individuals knowing how particular conventions have been historically handled. For best practice, Marc and Alice suggest identifying existing workarounds now and preparing accordingly.
Finding #3: Four Domains, Similar Readiness Challenges
During the webinar, Marc and Alice detail the common problems within the four domains of microscopic findings, immunogenicity and cell phenotyping, nervous system findings, and skin testing results. One consistent finding among all was that organizations may already be performing the science required for SEND v4.0, but that the resulting information is not necessarily captured in a SEND-ready form. For example:
- In microscopic findings, negative correlations may be recorded but not carried into SEND output
- In nervous system assessments, scoring scales can exist outside the data-collection system
- In immunogenicity and cell phenotyping, metadata requirements such as gates and marker strings may not be captured electronically
Skin testing demonstrated a similar challenge. Workshop participants reported considerable variation in how scoring was standardized and scored. Only 4 of 16 respondents described their irritation scoring as fully standardized.
The webinar indicates how SEND v4.0 readiness transcends simply translating existing data differently. In some cases, organizations will need to reconsider what information is captured and how it is captured.
What These Findings Mean for Organizations
During the workshops, just 50% of participants reported being very familiar with the SEND v4.0 changes.
One of the strongest messages from the webinar was that responsibility for SEND v4.0 is organization-wide. The necessary knowledge for SEND should be distributed across pathologists, safety pharmacologists, scientists, study teams, data managers, system owners, and regulatory professionals, in addition to SEND professionals.
During the final portion of the webinar, Marc and Alice highlight practical steps for organizations to become ready for SEND v4.0:
- Get the scope in front of the right people: Increasing the scope introduces other groups to SEND
- Map workflows across requirements: In particular, watch for pitfalls such as scoring scales and result modifiers
- Prioritize the high-risk gaps first: This allows the issues with the highest risk of regulatory exposure to be promptly addressed
- Decide what changes in collection, and what does not: Streamline the process versus creating overburdened data collection
Conclusion: Prepare Early for the SEND v4.0 Update
The “SEND v4.0 Readiness Starts at Data Collection” webinar highlights many key issues and concerns facing sponsors and CROs looking to prepare for SEND v4.0.
A key takeaway is that organizations should understand their current data collection workflows, identify gaps early, and bring scientific, operational, and SEND teams together to better manage the transition, rather than waiting for submission requirements to expose weaknesses downstream. Preparation can begin now by understanding where data is housed, and determining whether it is being captured in a form compliant with SEND v4.0.
To explore the workshop findings in more detail, read our white paper “SEND v4.0 Readiness Starts at Data Collection”.
