Produce a Study Report + SEND Dataset in 2–3 Weeks
Most nonclinical CROs take 8 to 10 weeks to deliver a study report and its SEND dataset, because two teams rebuild the same data twice. Here's how producing both from one governed source cuts that to 2 to 3 weeks after data lock, without loosening a single FDA requirement.
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...
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.
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 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...
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 from the same underlying data. This sequential workflow adds 4-5 weeks to submission timelines,...
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 began as an observational critique of spreadsheet-based standards management evolved into a broader vision -...
SOT 65th Annual Meeting and ToxExpo
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 at Phuse APAC Connect 2026
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...
Revolutionary Single – Track Process Transforms Nonclinical Data Management
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...
Does my Study need SEND?
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...
PHUSE EU Connect 2025
Event Date: 16 – 19 November 2025Location: Hamburg, Germany 𝐀𝐬 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐝𝐚𝐭𝐚 𝐠𝐫𝐨𝐰𝐬 𝐦𝐨𝐫𝐞 𝐜𝐨𝐦𝐩𝐥𝐞𝐱, 𝐦𝐞𝐭𝐚𝐝𝐚𝐭𝐚 𝐜𝐚𝐧’𝐭 𝐛𝐞 𝐚𝐧 𝐚𝐟𝐭𝐞𝐫𝐭𝐡𝐨𝐮𝐠𝐡𝐭.At PHUSE EU Connect 2025, Harinarayan Gopichandran, VP Technical Solutions at PointCross, demonstrated how the 𝐗𝐛𝐢𝐨𝐦 𝐒𝐦𝐚𝐫𝐭 𝐌𝐞𝐭𝐚𝐝𝐚𝐭𝐚 𝐑𝐞𝐩𝐨𝐬𝐢𝐭𝐨𝐫𝐲 (𝐌𝐃𝐑) helps Sponsors and CROs 𝘴𝘵𝘳𝘦𝘢𝘮𝘭𝘪𝘯𝘦 clinical trial setup, 𝘢𝘶𝘵𝘰𝘮𝘢𝘵𝘦 metadata governance, and 𝘪𝘮𝘱𝘳𝘰𝘷𝘦 consistency across studies. Managing metadata through...
Refreshing Clinical Data Validation for Modern BioPharma
Validation and study data quality should be thought of as iterative and continuous workflows. Yet, many teams still work within usage models and contract terms that make it harder to validate for rules and conformance checks as often as needed. eDataValidator was designed to change that. Built by PointCross, and used for well over 100,000...