How the FDA’s TCG v6.2 Update Validates What Rigorous SEND Preparation Has Always Required
As some may have heard, the FDA released their bi-annual update to the Technical Conformance Guide earlier this year. Along with slight corrections and improvements, an entire Appendix was added regarding SEND data review “Best Practices”. With the update, the FDA has formalized some industry wide best practices; better quality SEND datasets equates to more useful SEND for evaluation.
The formalization of these expectations in Appendix I is not a shift in FDA philosophy — it is the agency putting in writing what reviewers have long required in practice. For sponsors and CROs who have invested in rigorous SEND preparation processes, this update is a validation of that investment.
As the TCG update notes, selecting a vendor with demonstrated, verifiable processes for each of the expectations below is one of the most direct ways to mitigate submission risk. PointCross not only meets each of these expectations today, but has built dedicated processes around them to ensure every dataset we deliver is complete, consistent with the study report, and ready for regulatory review.
The FDA outlined a set of verifiable expectations for SEND data review prior to submission. These expectations are:
- Traceability
PointCross is the only SEND preparer to offer 100% reconciliation on every SEND dataset. The reconciliation process involves digitizing the study report, and recreating every individual and summary table with counts, means, and standard deviation to assure that every value in the dataset matches the study report. Where data is present in the report and cannot be added to the SEND dataset due to being out of scope, the absence of data is reported in the nSDRG.
- Conformance with the IG
PointCross follows the most up to date SEND Implementation Guide as supported by the FDA, listed in the Data Standards Catalog. As of publishing (June 2026), this is SEND IG v3.1.1, and associated child IGs. Each SEND dataset has 4 validations run on the package from the eDataValidator ensuring consistency with the appropriate SEND Implementation Guide, as well as many other checks for conformance.
- Grouping for Analysis
The PointCross-unique reconciliation process recreates every summary table in the report, allowing for grouping of not only dose group or sex together, but for custom cohorts to be accurately represented as they might be in the report.
- Creation of SEND dataset
The PointCross nSDRG template, based upon the PHUSE whitepaper, lays out the entire SEND dataset creation process, from the collection of study data at multiple sites, through evaluation of statistics and reading of histopathologic slides, and the creation of the SEND dataset within PointCross. Each step at PointCross is outlined with the source of the data, tools used to convert any files, and the tools used to create and verify the dataset. Finally, verification of the dataset is detailed with information as to where, if any, discrepancies may be present.
- Verification of SEND dataset
In conjunction with the above points, PointCross verifies each dataset with a rigorous QC process. A multi-step QC process starts with PointCross’s eDataValidator to confirm that the dataset is within standards to the FDA Technical Rejection Criteria, SEND IG, FDA Validator Rules, PMDA Validation Rules, CDISC SEND Conformance Rules, CDISC Open Rules Engine, and PointCross Extended Checks. The reconciliation report is annotated where data is not 100% aligned between all standards against the report and placed as a note within the nSDRG. Alongside, the dataset is individually checked for correctness to the complexities of the report, such as noting any deviations that took place, data that did not otherwise fit into a table, and comparing conclusions are appropriate with the data that is in the SEND dataset. With our rigorous checks, PointCross has a 100% acceptance rate for SEND datasets submitted to the FDA.
It is worth noting that PointCross did not build these processes in response to Appendix I. We built them because we believe data quality is paramount in the Life Sciences. Appendix I is a welcomed update from the FDA, one that reinforces what responsible SEND preparation has always required.
When standardized data is complete, consistent, and accurate, it reduces errors, accelerates review, and ultimately brings better therapies to patients faster. That has always been the standard we hold ourselves to, and it is the standard every submission we touch reflects.
If you would like to understand how PointCross approaches SEND preparation in the context of the updated TCG v6.2 requirements, or if you have an upcoming submission where SEND quality is a priority, we encourage you to reach out. Contact us at [email protected] to start a conversation.