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,...
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.
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.
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...
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...
Webinar- Automating Study Report and SEND Integration in Nonclinical Safety Studies
Learn 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.
Three Steps to Transforming CRO Productivity: Time, Cost, and Quality in Nonclinical Study Reporting
Nonclinical contract research organizations (CROs) face a structural inefficiency in the preparation of exploratory and pivotal toxicology study packages: the Study Report and its companion SEND (Standard for Exchange of Nonclinical Data) dataset are generated through two separate, sequential processes...
PointCross at PHUSE US Connect 2026
At PHUSE US Connect 2026 in Austin, PointCross Life Sciences’ Rahul Madhavan, alongside collaborators from Merck Group and Daiichi Sankyo, led a hosted session on “Building a Better MDR” and introduced the soft launch of an industry-first white paper. What...
