About CCIS

Clinical Communication Intelligence System

Overview

CCIS is a purpose-built clinical communication management platform designed for medical device post-market clinical follow-up (PMCF) studies. It centralizes all site communications, applies intelligent categorization and risk-based prioritization, automates regulatory countdown tracking for safety events, and generates audit-ready documentation—reducing manual workload for Clinical Research Associates while strengthening EU MDR compliance.

Key Capabilities

• Intelligent Communication Triage — ML-based categorization and confidence scoring for inbound site communications
• Risk-Based Prioritization — Automatic escalation of safety events, overdue items, and silent sites
• EU MDR Article 87 Countdown Tracking — Real-time regulatory deadline monitoring for SAE/AE reporting
• Draft Response Workflow — AI-assisted response generation with human-in-the-loop approval
• Role-Based Views — Tailored dashboards for CRAs, Clinical Operations Managers, and Safety Officers
• Append-Only Audit Trail — Immutable, timestamped record of every system action for regulatory inspection readiness
• Multi-Site Portfolio Management — Consolidated view across investigation sites with phase tracking and risk flags

Regulatory Compliance

EU MDR 2017/745

Article 87 safety reporting timelines, PMCF study communication management, and clinical investigation oversight per Annex XV.

GAMP 5

Category 5 (configured) software with IQ/OQ validation protocols, traceability matrix, and risk-based testing approach.

EU AI Act

Human-in-the-loop design for all AI-assisted features. No autonomous clinical decisions—all outputs require human approval.

Technical Architecture

Backend

FastAPI + Python 3.12

Database

SQLite + SQLAlchemy

Frontend

Jinja2 + HTMX + Alpine.js

Styling

Tailwind CSS

Single-binary deployment via PyInstaller. No external API dependencies required for the demo build—all ML inference uses local models bundled with the application.

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