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Check out some of our latest blog posts:
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.
April 2026
What the FDA’s TCG v6.2 Update Means for Your SEND Deliverables
The FDA has rolled out version 6.2 of its Study Data Technical Conformance Guide, and if you sponsor nonclinical studies, it is worth understanding what changed before your next submission lands. Most of the update simply codifies practices that experienced SEND providers already follow - but there is one structural change that will affect...
Welcoming PingPing Gong to PointCross
As part of our continued global expansion, PointCross Life Sciences is pleased to welcome PingPing Gong as Senior Director, Business Development – China / APAC. Based in Shanghai, Pingping will lead business development initiatives across China and the broader APAC region. She brings extensive experience partnering with CROs and sponsors, supporting the adoption of scalable...