For preclinical data submissions, successful Standard for Exchange of Nonclinical Data (SEND) submissions have moved beyond formatting requirements. As regulatory review becomes more dependent on structured and complete datasets, sponsors and CROs need to think differently about what “ready” really means.
In a webinar held on Thursday, June 4, 2026, Instem’s Rachel Harper, Vice President of Global Service Delivery, and Marc Ellison, Director of SEND Solutions, discussed a challenge facing many in the industry – SEND packages that pass standard checks, but cause problems once reaching the review environment. The session, “When SEND Quality Matters Most”, explored the recent FDA communications regarding data quality, why regulatory expectations are shifting, where common issues arise, and how organizations can strengthen confidence before filing SEND datasets for review.
What Recent FDA Announcements Mean for Sponsors
Recent updates to the FDA’s Technical Conformance Guide (TCG) and public communications from Stephanie Leuenroth‑Quinn, Associate Director for Pharmacology and Toxicology at the FDA’s Office of New Drugs, indicate that there has been an intrinsic shift from prioritizing rule-based compliance to supporting improved reviewer confidence.
As also recently explored in Instem’s blog, “What the FDA Webcast Revealed About SEND (and Why It Matters)”, the webinar highlights the TCG updates, indicating that the FDA is increasing focus on the practical usability of SEND submissions.
Fortunately, these TCG updates are unambiguous. The guide clearly indicates that sponsors should concentrate on completing the SEND review before submission to Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), focus on trial design domains, ensure data and Define-XML accuracy, align metadata with submitted data, and complete holistic conformance evaluations beyond automated checks.
Likewise, announcements from Stephanie Leuenroth‑Quinn have also provided a clearer picture on how data quality is impacting SEND submissions. It was indicated that load ability issues represent a significant barrier, rather than a minor inconvenience, that impacts the review process.
Why Passing Validation May Not Be Enough
In a dedicated section of the webinar, Rachel discusses “When Validation Success is Not Enough”. This portion of the session details what many sponsors may have experienced informally: SEND datasets that pass validation steps, but fail to meet FDA expectations during review. This experience provokes questions about what validation success actually means.
Automated validation tools detect rule-based issues. These may include missing variables, incorrect control terminology, or structural non-conformance. What these tools do not detect is whether datasets can be loaded seamlessly into the FDA review systems. As indicated by the recent updates, regulators need datasets that can be reviewed, interpreted, and assessed smoothly, without the need for extra clarification and manual rework.
The rationale behind why this is crucial can be defined by the review process itself. Load ability issues and inconsistencies across the dataset limit the ability of reviewers to view or trace study elements, issues that not only slow review but also erode reviewer trust in the data. Discrepancies and ambiguous definitions can easily be overlooked, and reliable interpretation becomes questionable. These issues underpin why the prioritization of SEND data quality is essential.
Common Issues That Undermine SEND Quality
For SEND datasets, there are a number of issues that can occur across structural and relational domains, metadata and Define-XML management, and controlled terminology and interpretation. During the webinar, Rachel and Marc discussed the common problems experienced by sponsors and regulators. These include:
- Structural issues: These errors can weaken the usefulness of the entire SEND package. When study domain relationships, identifiers, or timing variables do not align, the reviewer’s ability to follow the data is compromised.
- Metadata misalignment: Improperly handled metadata creates risk. Define-XML that inaccurately describes what is in the datasets, including variable origins, derivations, code lists, and comments, is fundamentally flawed. When metadata is out of sync, reviewers may be left with conflicting signals about how the data should be interpreted.
- Inconsistent terminology: Terminology choices matter. Inconsistent, outdated, or mixed controlled terminology can affect filtering, analysis, aggregation, and comparison across studies.
Practical Steps Towards Higher-Quality SEND Datasets
When considering best practices towards dataset verification and improved data quality, Rachel and Marc note that there are several actions that can be taken to mitigate common SEND submission mistakes.
SEND quality should be built holistically into workflows, not as a final checkpoint, and sponsors can reduce risk by:
- Verifying the dataset against FDA rules
- Checking for trial design integrity
- Ensuring endpoint completeness
- Examining consistency between the SEND dataset, Define-XML, and the study report
- Reviewing structure, completeness, and consistency early
- Maintaining metadata alongside the datasets
- Checking relationships across domains
- Using the nSDRG to document missing endpoints or grouping variables for accurate summarization
- Involving SEND experts before submission deadlines become urgent
Ultimately, Rachel emphasizes that SEND data must not only pass validation but also reproduce the study results.
Building Confidence Before Submission
In a final showcase before the Q&A session, Rachel and Marc demonstrated how Instem’s SEND Advantage™ services are designed to help organizations create, check, and improve SEND packages. SEND Deliver supports dataset creation. SEND Comply provides an independent quality review, and additional services such as SEND Advise, SEND Source, and SEND Warehouse offer flexible support across different stages of SEND maturity.
Instem’s comprehensive support and deep expertise set it apart as the global leader in SEND services.
Summary
The central takeaway from the webinar is that SEND success now depends on more than passing checks. Sponsors need datasets that reviewers can understand, navigate, and trust. By focusing on data consistency, study traceability, metadata accuracy, terminology, and report alignment, organizations can reduce avoidable delays and approach SEND submission with greater confidence.
To learn more, watch the full webinar or request a demo to discover how the SEND Advantage™ services can help your organization build higher-quality SEND packages for regulatory submission.
