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.
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.
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.
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.
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 from the same underlying data. This sequential workflow adds 4-5 weeks to submission timelines,...
Date: March 22–26, 2026Location: San Diego, California PointCross attended the Society of Toxicology (SOT) 65th Annual Meeting and ToxExpo, held March 22–26, 2026, in San Diego, CA. The event brought together leading toxicologists, researchers, regulators, and industry professionals to share the latest scientific discoveries, technologies, and regulatory advancements in toxicology. At Booth #2107, the PointCross team...
PointCross Life Sciences was proud to participate in PHUSE APAC Connect 2026, held from 19–21 February 2026 in Hyderabad, India. The event brought together global leaders across clinical data science, innovation, and regulatory standards, alongside India CDISC Day, uniting two influential data standards communities under one platform. During the conference, PointCross contributed through both paper and...
Xbiom™ Platform Introduces AI-Enabled Automated Workflow that Eliminates Redundant Processes, Reduces Costs by 50%, and Accelerates IND-Enabling Regulatory Submission Readiness by 2-4 Weeks. Foster City, CA, December 18, 2025 PointCross today announced general availability of an AI augmented transformative single-track process for nonclinical data management. The innovation enables simultaneous generation of submission-ready Study Reports and...
As a toxicologist running multiple GLP and non-GLP studies, you and your team often plan budgets, study schedules, and contracting activities with your CRO and external vendor labs. There is, often times, one critical-path topic that often appears as a line item in a Statement of Work between you and your CRO partner. That line...
Ensuring the quality of data submitted to regulatory agencies like the FDA (CBER and CDER) is vital in the Life Sciences industry. For nonclinical studies, the standard format is SEND (Standard for the Exchange of Nonclinical Data). SEND provides a standardized structure for submitting data, and adherence to its implementation guides (like IG 3.1.1,...