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
See the modules
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
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.

Overview

ClinPrecision Product Overview

A full walkthrough of the platform — modules, architecture, compliance posture.

Market

Strategic Positioning

How ClinPrecision compares to the incumbents and where AI-native design matters.

Technical

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)