Trusted by Medical Device Sponsors

Informed Clinical™ System for FDA Trials

Informed Clinical™ delivers enterprise-grade data committee infrastructure for FDA-regulated medical device trials. Full compliance, comprehensive audit trails, and real-time clinical data monitoring.

100%
FDA Compliant
Unlimited
Data Cuts
Real-Time
Change Tracking
Fully
Validated

Built for sponsors who demand excellence

Informed Clinical™ provides the infrastructure and tools sponsors need for efficient, compliant data committee operations.

FDA Inspection Ready

Complete regulatory compliance with comprehensive audit trails. Every data access logged for regulatory review.

Enterprise Data Management

PostgreSQL-backed architecture with comprehensive audit trails and intelligent change tracking across unlimited data cuts.

Automated Change Detection

Compare any two data cuts instantly. Automatically identify new subjects, updated records, and modified values.

Clinical Visualization Suite

Interactive time-series charts for clinical scores. Real-time visualization of patient trajectories and outcomes.

Regulatory Documentation

Export-ready adverse event tables with severity indicators. Generate regulatory submission documentation instantly.

Role-Based Security

Row-level security with granular access controls. Compliant data handling and security.

The Informed Clinical™ platform

A comprehensive clinical data infrastructure that centralizes patient data, clinical outcomes, and adverse event monitoring. Built specifically for data committee workflows.

Interactive time-series visualizations for clinical scores
Color-coded neurological assessment heatmaps
Integrated radiography viewing with DICOM support
Comprehensive adverse event tracking and export
Automated ETL pipeline with data validation
Data Committee Dashboard Interface
Clinical Scores
Neurological
Radiography
Adverse Events
Subject ID:Subject ID
Clinical Score
42
Clinical Outcome
6.8

Enterprise-grade data architecture

Built on PostgreSQL with comprehensive audit trails and intelligent change tracking.

Database Export
CSV data cuts
ETL Pipeline
Automated validation
Cloud Database
Full audit trails
Dashboard
Real-time review

Security & compliance built-in

FDA inspection-ready with fully compliant architecture meeting all regulatory requirements.

Row-Level Security (RLS) for role-based access
Service role key restricted to admin operations
All credentials secured in environment variables
Every data access logged with timestamp and user
Complete audit trails for FDA inspections
Compliant data handling and security

Experience the Informed Clinical™ difference

Discover how our enterprise-grade data committee infrastructure can transform your clinical trial operations.