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Author - Kavan Palangappa

PointCross Testing

Revolutionary Single – Track Process Transforms Nonclinical Data Management

Xbiomโ„ข 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...

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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...

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PHUSE EU Connect 2025

Event Date: 16 โ€“ 19 November 2025Location: Hamburg, Germany ๐€๐ฌ ๐œ๐ฅ๐ข๐ง๐ข๐œ๐š๐ฅ ๐๐š๐ญ๐š ๐ ๐ซ๐จ๐ฐ๐ฌ ๐ฆ๐จ๐ซ๐ž ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ฑ, ๐ฆ๐ž๐ญ๐š๐๐š๐ญ๐š ๐œ๐š๐งโ€™๐ญ ๐›๐ž ๐š๐ง ๐š๐Ÿ๐ญ๐ž๐ซ๐ญ๐ก๐จ๐ฎ๐ ๐ก๐ญ.At PHUSE EU Connect 2025, Harinarayan Gopichandran, VP Technical Solutions at PointCross, demonstrated how the ๐—๐›๐ข๐จ๐ฆ ๐’๐ฆ๐š๐ซ๐ญ ๐Œ๐ž๐ญ๐š๐๐š๐ญ๐š ๐‘๐ž๐ฉ๐จ๐ฌ๐ข๐ญ๐จ๐ซ๐ฒ (๐Œ๐ƒ๐‘) helps Sponsors and CROs ๐˜ด๐˜ต๐˜ณ๐˜ฆ๐˜ข๐˜ฎ๐˜ญ๐˜ช๐˜ฏ๐˜ฆ clinical trial setup, ๐˜ข๐˜ถ๐˜ต๐˜ฐ๐˜ฎ๐˜ข๐˜ต๐˜ฆ metadata governance, and ๐˜ช๐˜ฎ๐˜ฑ๐˜ณ๐˜ฐ๐˜ท๐˜ฆ consistency across studies. Managing metadata through...

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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...

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PointCross at PHUSE SDE Bengaluru 2025 – Gold Sponsor

Event Date: Saturday, 22 November 2025Location: Bengaluru, India About the Event The PHUSE Single Day Event (SDE) in Bengaluru brought together leaders across the clinical research ecosystem to discuss how emerging technologies -AI, ML, RPA, and intelligent data systems are transforming clinical data science. With the industry rapidly shifting toward automation and real-time analytics, the event...

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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 the work itself. It's how we manage the metadata that gives meaning to clinical data What...

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Bridging the Gap: How Natural Language AI Can Transform Clinical Data Access

As the BioPharma industry evolves toward more data-intensive, portfolio-wide agile decision-making, under pressure to innovate and reduce the time to market, organizations that master bridging the questions of their staff to regulatory compliant, verifiable responses retrieved from their study data systems will move faster, decide smarter, and ultimately bring therapies to patients more efficiently,...

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Ask with Ease. Retrieve with Rigor. Study Data Secured by RAG-Enabled Chat in Xbiom

The biopharmaceutical industry is entering a new era where the ability to harness data directly determines the speed and success of drug development. Clinical trials, nonclinical studies, and biomarker assays now generate massive volumes of complex data. When unified and made accessible, clinical trial data accelerates insights, strengthens regulatory confidence, and reduces development risk. PointCross enables...

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How Leaders Can Shape Drug Success Through Data

The Case for Faster, Smoother Approvals Every day saved in the approval process matters. Faster reviews mean therapies reach patients sooner, investors see value earlier, and science delivers its impact without avoidable setbacks. The encouraging news is that most delays are not because science failed. They happen because submissions were not fully supported by strong data...

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The Hidden Bottleneck Undermining Pharma’s Mission

Every pharma executive faces the same core challenge: developing safe, efficacious therapies that reach patients while delivering sustainable returns. The industry exists for one fundamental purpose: to discover, develop, and deliver innovative treatments that are both clinically proven and commercially viable. Yet despite record R&D investments, most companies are trapped in cycles that work against...

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