Master Protocols
Baskets, umbrellas, and platform trials designed natively — not forced into a conventional single-arm interventional template. Cohorts open, close, and adapt at runtime with their own lock and submission lifecycles.
Novatra AI · Clinical Intelligence Platform
AI-native platforms for modern clinical trials.
Novatra AI builds regulatory-grade clinical software where artificial intelligence is a first-class design principle — not a feature bolted on afterwards. Our flagship platform, ClinPrecision, unifies EDC, CTMS, eTMF, and QMS in a single, audit-ready workspace for sponsors, CROs, and research sites.
21 CFR Part 11
audit-ready
HIPAA
privacy-by-design
GxP
validated workflows
Multi-tenant
on-prem or cloud
Why Novatra AI
Built for the trials of the next decade.
Regulatory-grade foundation
Every action is captured in an event-sourced audit trail. 21 CFR Part 11, ICH GCP, and HIPAA are designed in at the aggregate layer — not papered over with after-the-fact logs.
AI-native workflows
Protocol inference, eligibility assistance, safety-signal surfacing, and document-quality review run where the data lives. Assistance is observable, reviewable, and rollback-safe.
One unified platform
EDC, CTMS, eTMF, QMS, and regulatory reporting share a single data model and identity. No CSV bridges, no schema drift, no reconciliation teams.
Flagship Product
ClinPrecision — the unified clinical workspace.
ClinPrecision replaces the patchwork of EDC, CTMS, eTMF, and QMS tools that sponsors and CROs run today. Study teams design, capture, monitor, and submit from one platform, with a single source of truth for every data point and every document.
- Interventional, observational, and master-protocol studies supported natively
- Study-type-driven workflows — no hand-rolling observational flows on top of interventional assumptions
- Deployable on-prem, in the cloud, or air-gapped for sovereign-data regulations
- Integrated QMS — SOPs, training, CAPA and deviations never leave the platform
EDC
CTMS
eTMF
QMS
Reports
AI
One data modelOne audit trail
ClinPrecision Modules
Nine modules, one platform, zero integration tax.
Every module reads and writes the same event-sourced data model. Turn on what you need today; bring the rest online without a migration.
Electronic Data Capture
- CRFs with built-in edit checks
- Scheduled + unscheduled visits
- SDV and query workflows
Clinical Trial Management
- Sites, monitoring visits, deviations
- Enrollment and retention dashboards
- Financial + milestone tracking
Electronic Trial Master File
- TMF reference model mapping
- Completeness and validation reports
- On-prem or S3-compatible storage
Quality Management
- SOPs, training matrix, CAPA
- Deviation lifecycle
- Audit and inspection readiness
Study Design
- Protocol-driven visit schedules
- Arms, cohorts, and master protocols
- Publish + version workflow
Inspector Portal
- Scoped, read-only regulator access
- Watermarked document viewer
- Full inspector-action trail
Reporting & Analytics
- SDTM DM-domain export
- Pooled safety and CSR workflows
- Configurable study dashboards
Data Quality
- Cross-form validation rules
- Medical review + coding queues
- Database lock readiness gates
AI Copilot
- Protocol inference from narrative
- Safety-signal surfacing
- Document-quality review assist
Differentiated Capabilities
What you can't build out of a commodity EDC.
Each of these is a deliberate architectural choice. They exist because the trials we want to enable — adaptive, AI-assisted, master-protocol, digital-twin–controlled — don't fit the single-study single-arm assumptions the category was built on.
Patient Digital Twins
AI-generated virtual replicas of each enrolled subject predict disease progression under standard of care. That enables individual-level counterfactual treatment-effect estimation, richer interim analyses, and smaller concurrent control arms.
Protocol Simulation Engine
Run thousands of virtual executions of your protocol before site activation. Stress-test enrollment assumptions, visit windows, dropout, and statistical power under realistic noise — and flag weak spots while amendments are still cheap.
eConsent
Electronic informed consent with multimedia explanation, comprehension checks, and tamper-evident signatures. Fully integrated with the subject registry and the audit trail — no third-party consent tool to reconcile.
Risk-Based Reporting
Centralised monitoring dashboards, KRI alerts, DSURs, PSURs, and pooled-safety analyses driven off the same event stream that captures the trial. Reports are generated, not re-constructed after the fact.
Smart Metadata & Protocol Inference
Upload a protocol document and the platform infers visit schedules, arms, eligibility, forms, and edit checks as review-ready drafts. Build times drop from weeks to hours while the audit trail preserves every human decision.
What sets us apart
Compliance, breadth, and flexibility — no compromises.
21 CFR Part 11
Audit-ready e-signatures and tamper-evident trails by default.
Three study types
Interventional, observational, and master protocols — all first-class.
Multi-tenant
Per-sponsor data isolation with shared governance controls.
On-prem or cloud
Deploy inside your firewall or on managed infrastructure.
Event-sourced
Every state change is replayable. Nothing is silently overwritten.
Integrated QMS
Deviations, CAPA, and training never leave the platform.
Resources
Go deeper.
Product detail for evaluators, architectural briefs for engineering leaders, and regulatory commentary for quality teams.
ClinPrecision Product Overview
A full walkthrough of the platform — modules, architecture, compliance posture.
Strategic Positioning
How ClinPrecision compares to the incumbents and where AI-native design matters.
Technical Capabilities
Event-sourced architecture, CQRS aggregates, and the end-to-end audit trail in detail.
Get in touch
Ready to see ClinPrecision in action?
Book a guided walkthrough with our team. We'll scope a pilot study around your workflow, not the other way around.
hello@novatra-ai.com +1 (000) 000-0000
Compliance & Standards
21 CFR Part 11HIPAAGxPICH GCPISO 27001 (in progress)