What Causes SDTM, ADaM and SEND Validation Failures
SDTM, ADaM, and SEND datasets form the backbone of regulatory submissions to the FDA, PMDA, and other agencies. Yet validation failures in these datasets remain one of the most common obstacles to achieving submission readiness. Understanding why these failures occur...
How to Fix SEND Compliance Gaps in Mid-Sized Biotechs
Learn how mid-sized biotechs can fix internal SEND compliance gaps. PointCross explains workflow issues, traceability solutions, and submission readiness steps.
SEND Validation for FDA and PMDA in 2026
Why SEND Validation Matters for Your FDA and PMDA Submissions Your nonclinical study data must clear FDA validation before a reviewer ever sees it. A malformed dataset, missing Trial Summary file, or mismatch between your SEND package and study report...
How to Choose SEND Dataset Services in 2026
Why Selecting the Right SEND Dataset Service Matters FDA-compliant SEND dataset services determine whether your nonclinical submission clears the gateway or gets rejected. With SENDIG v3.1.1 now required for studies starting after March 15, 2023, and SENDIG-Genetox v1.0 mandated for...
Connecting Preclinical and Clinical Data in Biopharma
Clinical data automation platforms have become essential for large biopharma R&D teams working to bridge the gap between preclinical findings and clinical outcomes. When your organization invests significant resources in discovery and nonclinical studies, that data needs to flow into...
Produce a Study Report + SEND Dataset in 2–3 Weeks
Most nonclinical CROs take 8 to 10 weeks to deliver a study report and its SEND dataset, because two teams rebuild the same data twice. Here's how producing both from one governed source cuts that to 2 to 3 weeks...
SEND Datasets: The Complete Guide
SEND datasets are the standardized, machine-readable files the U.S. FDA requires for nonclinical study data in most drug and biologics submissions. If you run toxicology studies, assemble regulatory filings, or manage data at a CRO, SEND datasets are no longer...
SEND 4.0 Is Coming. Here’s What You Actually Need to Know.
CDISC opened public review for SENDIG v4.0 in April 2026, with publication targeted for Q4 2026. While the FDA has not yet announced an implementation timeline, many CROs and sponsors are watching from a distance. That posture has a cost. SENDIG v4.0 isn’t just another version update. It introduces...
Mitigating risk with PointCross
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...
5 SEND Compliance Challenges Nonclinical CROs Must Solve
This article breaks down the real SEND compliance challenges that nonclinical CROs face, grounded in current FDA and CDISC requirements, and shows where disciplined process and the right tooling change the outcome. We write this for toxicologists, regulatory affairs professionals,...
