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...
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...
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...
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 you’re 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...
Abstract Large Language Models (LLMs) have the potential to significantly accelerate therapeutics development while reducing costs and increasing innovation in the biopharmaceutical industry. However, two critical barriers prevent widespread adoption of this technology. First, competitive sensitivities and data sovereignty requirements mandate that clinical trial and nonclinical study data remain within pharmaceutical companies' secure networks. This necessitates...