Catch Documentation Errors Before They Become Queries

AI-powered validation that helps CROs prevent costly documentation queries before monitoring visits. Upload CRFs, validate signatures and dates in real-time, and fix issues before they trigger rework.

Upload CRF pages via mobile app

Real-time validation in <90 seconds

Fix issues before CRA review

25-40% fewer ALCOA queries

Request Pilot Access See How It Works

Built for mid-sized CROs running Phase II/III trials

✓ 95-98% AI accuracy✓ 50+ CRFs validated

NOVA Dashboard

Active Studies

Sites

1,248

Patients

98%

Compliance

Site #12 enrollment on track

Document validation pending

How Nova Works

Upload → Validate in Real-Time → Fix Before Review

Upload

Site coordinators scan or upload CRF pages using their mobile device—the same document submission workflow already standard in remote SDV (rSDV) systems.

Validate in Real-Time

Nova's AI models analyze documents instantly during upload to detect missing signatures, incorrect or missing dates, undated corrections, ALCOA compliance violations, and chronological inconsistencies.

Fix Before Review

Nova generates validation reports in real-time, allowing site coordinators to correct issues immediately—before CRA review. Issues are surfaced in Nova's compliance dashboard with automated notifications.

The Cost of Documentation Errors

Missing signatures and undated corrections trigger expensive monitoring queries—most resulting in no actual data changes

$152K-$278K

Saved per Phase II trial

Through query prevention

25-40%

ALCOA queries prevented

Real-time validation

71.9%

Queries result in no data changes

Industry data (IntuitionLabs)

125-310%

ROI for Phase II trials

3-6 month payback

Why Catch Errors Early?

Issues Found During Monitoring

• Missing investigator signatures
• Undated corrections and modifications
• Inconsistent timestamps across pages
• Illegible handwritten entries
• ALCOA compliance violations

Nova Prevents Before Monitoring

• Real-time validation during upload
• Site coordinators fix before CRA review
• Fewer monitoring queries and rework
• Reduced repeat visit cycles
• Lower per-trial operating costs

Prevention costs 1/10th of detection. Nova validates at the most cost-effective point—before issues enter the monitoring cycle.

Nova Platform Components

CRF Mobile validates documentation before monitoring. The compliance dashboard gives CRAs and site managers real-time visibility across trials.

CRF Mobile

Pilot Ready

Upload → Validate → Fix Before Review

Nova's first product: a mobile app for site coordinators to validate CRF documentation before CRA review—integrating into existing remote monitoring workflows.

Key Capabilities:

Upload CRF pages via camera or photo library
Real-time AI validation in <90 seconds
Detect missing signatures, incorrect dates, ALCOA violations
Fix issues before monitoring queries
Works offline with cloud sync

Document Validation Engine

95-98% Accuracy

AI-Powered ALCOA Compliance

Automated analysis validates CRFs against ALCOA criteria: Attributable, Legible, Contemporaneous, Original, and Accurate documentation standards.

Key Capabilities:

Signature presence detection
Date format validation
Chronological consistency checks
Legibility assessment
Compliance scoring and reports

Compliance Dashboard

Operational

Real-Time Issue Visibility

Web dashboard surfaces validation results across sites and studies, giving CRAs and site managers visibility before monitoring visits.

Key Capabilities:

Real-time validation alerts
Trial-level compliance reporting
Site performance tracking
Issue resolution workflow
Automated email notifications

Deployment & Infrastructure

CRF Mobile captures and validates documents → syncs to Supabase backend (PostgreSQL + Storage) → feeds Web Dashboard with real-time compliance data. HIPAA-compliant with end-to-end encryption and audit logging.

Deployed within 48-72 hours using existing CRF documents. No integration required—works alongside your current EDC and eTMF systems.

Ready for Pilot Deployment

Validated on 50+ CRFs across 3 Phase II/III trials. Ready to deploy on your active trials with 3-month pilot programs starting at $10,000.

Request Pilot Access

Platform Roadmap

From mobile-first validation to portfolio-level intelligence

Pilot Ready

CRF Mobile

Mobile app for site coordinators to upload and validate CRFs before CRA review. Upload → Validate → Fix workflow.

Operational

Real-Time Validation Engine

AI-powered ALCOA validation in <90 seconds. Detects missing signatures, incorrect dates, compliance violations.

Operational

Compliance Dashboard

Real-time issue visibility across sites and studies. Automated notifications for CRAs and site managers.

Planned

EDC Integration

Seamless integration with existing EDC systems for automated data flow and validation synchronization.

Planned

Predictive Risk Analytics

Early detection of trial execution risks based on documentation patterns and compliance trends.

Future Vision

Portfolio Intelligence

Multi-trial analysis for sponsors and large CROs. Centralized compliance insights across trial portfolios.

Ready for deployment: Core platform validated on 50+ CRFs across 3 Phase II/III trials, achieving 95-98% accuracy. Currently executing reference validation at 2 research sites (Q1 2026), with CRO pilot programs launching Q2-Q4 2026.

Prevent Queries Before They Happen

3-month pilots start at $10,000. Deploy on 2-3 trials and measure query reduction before committing to annual contracts.

48-72 hour deployment

95-98% AI accuracy

Target 25-40% query reduction

Request Pilot Access View Use Cases

Validated on 50+ CRFs across Phase II/III trials