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.
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What the FDA’s TCG v6.2 Update Means for Your SEND Deliverables
Kavan Palangappa2026-04-28T05:55:58+00:00The 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
Kavan Palangappa2026-04-21T10:44:25+00:00As 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
Geetha2026-04-15T07:12:02+00:00Learn 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
Kavan Palangappa2026-05-20T05:27:19+00:00Nonclinical 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
Geetha2026-04-01T11:45:22+00:00At 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
Geetha2026-04-01T11:42:17+00:00Date: 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
Kavan Palangappa2026-02-25T11:43:33+00:00PointCross 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...
Does my Study need SEND?
Kavan Palangappa2025-11-26T05:17:53+00:00As 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...
Refreshing Clinical Data Validation for Modern BioPharma
Kavan Palangappa2025-11-14T06:05:42+00:00Validation 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...