Catch Documentation Errors Before They Become Queries
A Phase II trial generates over 5,000 queries at $54 each — more than $270,000 per trial. Nova validates CRFs in real time at the point of documentation, catching ALCOA errors and protocol violations before they become monitoring queries.
Built for mid-sized CROs running Phase II/III trials
NOVA Dashboard
Active Studies
Sites
Patients
Compliance
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
A Phase II trial generates over 5,000 queries at $54 each — more than $270,000 per trial. 71.9% result in no data changes. Nova prevents the most costly ones before they start.
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
- • Protocol visit windows missed or unrecorded
Nova Prevents Before Monitoring
- • Real-time ALCOA validation at document upload
- • Protocol cross-check: visit windows, dosing, assessments
- • Site coordinators fix in <90 seconds — before CRA review
- • Fewer monitoring queries and repeat visit cycles
It costs $1 to prevent an error at the point of documentation. $10 to fix it when a monitor finds it. $100 when a regulator does. Nova operates at the $1 stage — every time.
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 ReadyUpload → 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% AccuracyALCOA Compliance + Protocol Cross-Check
Three-layer validation: ALCOA criteria, clinical value ranges, and protocol cross-referencing. Nova checks not just whether a form is complete — but whether it follows the trial protocol.
Key Capabilities:
- Signature presence and date format validation
- Chronological consistency and legibility checks
- Clinical range checking — flags physiologically impossible values
- Protocol cross-check: visit windows, dosing schedules, assessment timing
- Compliance scoring and issue reports
Compliance Dashboard
OperationalReal-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.
Platform Roadmap
From mobile-first validation to portfolio-level intelligence
CRF Mobile
Mobile app for site coordinators to upload and validate CRFs before CRA review. Upload → Validate → Fix workflow.
Real-Time Validation Engine
AI-powered ALCOA validation in <90 seconds. Detects missing signatures, incorrect dates, compliance violations.
Compliance Dashboard
Real-time issue visibility across sites and studies. Automated notifications for CRAs and site managers.
EDC Integration
Seamless integration with existing EDC systems for automated data flow and validation synchronization.
Predictive Risk Analytics
Early detection of trial execution risks based on documentation patterns and compliance trends.
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.
Validated on 50+ CRFs across Phase II/III trials