Clinical Trial Platform: 35% Faster Patient Enrollment, FDA 21 CFR Part 11

The Challenge

A pharmaceutical company running multi-site clinical trials across 8 countries needed unified patient enrollment, electronic data capture, and adverse event reporting - all compliant with FDA 21 CFR Part 11 and EU GxP regulations.

The Solution

NINtec built a cloud-native clinical trial management platform with AI-assisted patient matching from registry databases, electronic data capture with full audit trails, automated adverse event detection from clinical notes using NLP, and real-time regulatory submission workflows.

Results

Technology Stack