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Check out some of our latest blog posts:
July 2026
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...
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, bioinformaticians, pharma and biotech executives, and the IT and data teams who live with...
The Business Case for Automating Nonclinical Study Reports
The study report and its SEND dataset are built twice from the same data. Automating nonclinical study reports deletes that duplication, cuts cost 30 to 50 percent, and removes the inconsistencies that trigger FDA queries.
May 2026
FDA SEND Requirements for Nonclinical Studies: Which Studies Need SEND Datasets in 2026?
Complete FDA SEND guide: which nonclinical studies require SEND datasets, SENDIG 3.1.1, DART, AR, Genetox deadlines, GLP rules, and IND/NDA scope explained.
AI in Nonclinical Reporting: From Hype to Real Workflow
Discover how AI is transforming nonclinical study reporting, from automated Module 2.4 drafts to FDA-compliant eCTD outputs. What is working, what is not, and what the FDA's 2025 guidance requires.
SEND Dataset Quality: Why Passing the Validator Is Only Half the Battle
Learn why SEND datasets fail FDA review even after passing validators, what the 2026 TCG requires, and how PointCross guarantees submission-ready quality.