⚠ The Challenge

Clinical data validation is reactive, not intelligent.

🔍

Errors Hidden Across Domains

Rule-based checks operate in silos — cross-domain inconsistencies stay invisible until submission.

⏱

Root Cause Takes Hours

Each issue demands manual investigation — 30 min to 2 hours per error, study after study.

📋

Queries Pile Up at Submission

Late-stage rework delays timelines and erodes regulatory confidence in data quality.

✦ The Platform
Kwalify™
Semantic Intelligence Driven Validation
Knowledge Graph Explainable AI GNN Anomaly Detection Cross-Domain Reasoning

Stop checking data. Start understanding it — root cause AI that explains every error, every time, in seconds.

01 · Validation Dashboard
📊
SDTM Validation Dashboard
Clean validation — zero noise. Instant clarity across all domains.
Dashboard · Overview SDTM Validation Dashboard
Real-time validation status across all SDTM domains — issue counts, severity and conformance score at a glance.
Dashboard · Domain View
Domain-level issue tracking with severity classification — pinpoint exactly where attention is needed.
Dashboard · Conformance
Protocol-to-dataset conformance checking — semantic rules enforced across the full data lifecycle.
Dashboard · Summary
Clean, actionable validation output — structured for regulatory submission readiness.
02 · Explainable AI
🧠
Issue Drill-Down & Root Cause AI
Every error explained. Every fix suggested. Root cause in one click.
XAI · Root Cause Analysis Study Validation Issue Drill-Down
Explainable AI surfaces the causal pathway behind every discrepancy — investigation reduced from hours to seconds.
03 · Anomaly Detection
🔬
GNN Anomaly Verification
Graph Neural Networks detect hidden patterns invisible to rule-based systems.
GNN · Anomaly Map
Graph Neural Network identifies structural anomalies across data relationships — catching what rules cannot.
GNN · Verification Report
Verified anomaly findings with confidence scoring — audit-ready evidence for every flagged record.
✓ The Outcomes
What Teams Achieve with Kwalify™
93%
Reduction in manual debug time per study
Zero
Submission rejections for conformance issues
<5s
Root cause identified vs. hours of manual work
1st
Submission readiness — no rework cycles