CARE2DATA Information

Founded by industry veterans with hands-on experience at PRA Health Sciences (now ICON plc) and KINSHIP Technologies, Care2Data brings 25+ years of proven expertise delivering clinical data solutions for global Phase I–IV trials. We are a clinical data quality solutions company engineered to help Pharma and CRO organizations deliver inspection-ready, regulatory-grade data across the entire trial lifecycle—from initial study design through final FDA, PMDA, and EMA submission. The Core Challenge We Solve Clinical trial data failures—specifically gaps in conformance, integrity, and quality—are the most costly and preventable risks in drug development. Regulatory rejections, complete response letters (CRLs), and timeline delays overwhelmingly trace back to deep semantic validation and verification gaps that existing legacy tools miss. Care2Data bridges these critical verification gaps by introducing a cognitive data layer that moves beyond rigid, siloed legacy systems. Our Core Technology Pillars: Semantic Intelligence, GraphAI, Linked Data, GNN Anomaly Detection Our Enterprise Solutions: ━━ KWALIFY™ | Semantic Intelligence Driven Validation and Anomaly Detection Intelligent, Knowledge Graph-powered validation and verification for clinical trial data. KWALIFY™ delivers context-aware, Explainable AI (XAI) validation across submission datasets. Its roadmap extends to Technical Rejection Criteria (TRC) covering the entire clinical trial lifecycle—moving beyond basic rule-checklist execution to auditable, submission-ready quality assurance. 🔗 Learn more: care2data.com/kwalify ━━ TrialGen™ | Synthetic Clinical Data Generation AI-powered generation of CDISC-compliant, protocol-aligned synthetic clinical trial datasets. Fully privacy-safe and statistically valid, TrialGen™ is built for feasibility studies, validation pipeline testing, team training, and submission simulation. 🔒 Compliance: GDPR · HIPAA · ICH E6 (R2/R3) compliant. 🔗 Learn more: care2data.com/trialgen