Investor Overview

Nova is building AI-powered pre-audit documentation validation for clinical trials, starting with CRF Mobile and expanding to a broader compliance intelligence platform.

Market Context

Nova operates in the contract research organization (CRO) industry

$24.1B

US CRO Industry Revenue

Annual market size

4,523

CRO Firms in US

Market participants

77%

Top 4 CRO Market Share

High concentration

2.1%

Annual Growth Rate

Through 2030

Structural Gap in Market

No existing system addresses pre-monitoring validation at the point of data capture. EDC systems validate after entry. Monitoring platforms detect post-visit. Nova prevents before monitoring.

Clear Differentiation

Medable detects issues post-visit. Harbor replaces data entry. Florence stores documents. Nova validates before any of these systems - owning the pre-monitoring validation moment.

Query Economics

Average query resolution costs $54, with 71.9% resulting in no data changes. Phase II trials generate approximately 5,000 queries; Phase III approximately 10,000. Prevention delivers immediate ROI.

Current Product Status

Nova's CRF Mobile and validation platform are pilot-ready, validated on 50+ CRFs across 3 Phase II/III trials with 95-98% accuracy. We're executing reference validation at 2 research sites (in progress), then launching CRO pilots (Q2-Q4 2026).

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CRF Mobile

Upload → Validate → Fix workflow, <90s per page, offline-capable

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Validation Engine

Signature detection, date validation, ALCOA scoring

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Compliance Dashboard

Real-time alerts, trial-level reporting, operational at dashboard.novabio.app

Go-to-Market Strategy

1. Reference Validation (In Progress)

2 research sites, 3-6 months, build proof points for CRO outreach

2. CRO Pilots (Q2-Q4 2026)

$10K 3-month pilots on 2-3 trials, targeting $500K ARR by year-end

3. Target Segment

Mid-sized CROs ($50M-$300M revenue) running Phase II/III trials

4. Business Model

$60K-$150K platform + $1,500-$3,000/trial/month. 15-20% value capture on ROI delivered.

Long-Term Platform Vision

From mobile-first validation to clinical trial intelligence platform

Phase 0: Reference Validation (In Progress)

Deploy at 2 research sites to build proof points for CRO outreach

Phase 1: CRO Pilots (Q2-Q4 2026)

3-month pilots with mid-sized CROs at $10K each, targeting $500K ARR by year-end

Phase 2: Platform Expansion

Predictive risk analytics, EDC integration, portfolio intelligence dashboards

Phase 3: Enterprise Scale

Large CRO deployments, sponsor direct sales, multi-trial portfolio management

Investor Inquiries

For information about Nova's roadmap, traction, and funding opportunities, please contact us directly.