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...
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...
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...
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...
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....
Metadata Repository: Your Strategic Edge in Clinical Development
Most research organizations spend 16-20 weeks setting up each clinical trial. Six of those weeks go to creating SDTM datasets alone. This isn’t just slow. It’s expensive, risky, and getting worse as regulatory requirements grow more complex. The problem isn’t...
