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Check out some of our latest blog posts:
August 2026
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 helps clinical data managers and operations leaders address root causes rather than just fixing...
July 2026
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.
PointCross Life Sciences Co-Hosted PHUSE Single Day Event in Foster City, CA
PointCross Life Sciences is proud to co-host the PHUSE Single Day Event (SDE) alongside Gilead Sciences on August 6, 2026, in Foster City, California. Centered around the theme, “Real-World Impact of Where AI Technology and Preclinical and Clinical Computation Meet,” the event will bring together industry leaders, researchers, and technology innovators to discuss how artificial...
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 can trigger a refuse-to-file decision that delays your entire program by weeks or months. The Standard...
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 after data lock, without loosening a single FDA requirement.
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 optional for in-scope studies. This guide explains what SEND is, who needs it, which...
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 some of the most significant structural changes since its original release. The changes extend far beyond routine version...
June 2026
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 FDA has formalized some industry wide best practices; better quality SEND datasets equates to...