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...
Event Date: 16 โ 19 November 2025Location: Hamburg, Germany ๐๐ฌ ๐๐ฅ๐ข๐ง๐ข๐๐๐ฅ ๐๐๐ญ๐ ๐ ๐ซ๐จ๐ฐ๐ฌ ๐ฆ๐จ๐ซ๐ ๐๐จ๐ฆ๐ฉ๐ฅ๐๐ฑ, ๐ฆ๐๐ญ๐๐๐๐ญ๐ ๐๐๐งโ๐ญ ๐๐ ๐๐ง ๐๐๐ญ๐๐ซ๐ญ๐ก๐จ๐ฎ๐ ๐ก๐ญ.At PHUSE EU Connect 2025, Harinarayan Gopichandran, VP Technical Solutions at PointCross, demonstrated how the ๐๐๐ข๐จ๐ฆ ๐๐ฆ๐๐ซ๐ญ ๐๐๐ญ๐๐๐๐ญ๐ ๐๐๐ฉ๐จ๐ฌ๐ข๐ญ๐จ๐ซ๐ฒ (๐๐๐) helps Sponsors and CROs ๐ด๐ต๐ณ๐ฆ๐ข๐ฎ๐ญ๐ช๐ฏ๐ฆ clinical trial setup, ๐ข๐ถ๐ต๐ฐ๐ฎ๐ข๐ต๐ฆ metadata governance, and ๐ช๐ฎ๐ฑ๐ณ๐ฐ๐ท๐ฆ consistency across studies. Managing metadata through...
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...
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...
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...
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,...
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...
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...
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...
Modern pharmaceutical companies take a different path on their journey into the digital age. CMOs and CSOs must have a say. If youโre a Chief Medical Officer, Chief Scientific Officer or Clinical Development leader, you know the frustration all too well: your teams are wrangling data from multiple sources, electronic data capture systems, labs, patient-reported...