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.
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SEND Validation for FDA and PMDA in 2026
Kavan Palangappa2026-07-31T06:46:43+00:00Why 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...
SEND Datasets: The Complete Guide
Kavan Palangappa2026-07-09T07:05:33+00:00SEND 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.
Geetha2026-07-07T05:20:39+00:00CDISC 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...
Mitigating risk with PointCross
Kavan Palangappa2026-06-09T04:39:45+00:00As 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
Kavan Palangappa2026-06-09T05:07:50+00:00This 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
Kavan Palangappa2026-06-03T09:52:41+00:00The 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.
FDA SEND Requirements for Nonclinical Studies: Which Studies Need SEND Datasets in 2026?
Kavan Palangappa2026-05-20T07:33:50+00:00Complete 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
Kavan Palangappa2026-05-20T06:23:59+00:00Discover 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.
Webinar- Automating Study Report and SEND Integration in Nonclinical Safety Studies
Geetha2026-04-15T07:12:02+00:00Learn how PointCross eliminates this bottleneck with Single Track Processing - simultaneously producing compliant Study Reports and submission-ready SEND datasets from a single governed data source, delivering both in 2–3 weeks after data lock with 30–50% cost savings.