CCIS
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Philips IGT-D · Clinical Operations

Clinical Communication
Intelligence System

The first purpose-built platform for managing clinical trial communication — from intake to audit-ready export.

The Challenge

Clinical Communication Is the Invisible Bottleneck

Home-based CRAs with risk-based monitoring manage 10-14 PMCF sites across multiple countries. They coordinate daily with 7 stakeholder groups — sites, sponsor teams, safety, data management, central monitors, ethics committees, and line management — across 8+ separate systems. 96% of trials now use RBM, but it shifted the burden from sites to screens, not away.

~65%

Of the day is not monitoring

Communication, meetings, training, admin

~30%

On communication alone

Emails, follow-ups, action items, calls

28-32%

CRO turnover rate

3x healthy rate — ACRP 2025

Zero

Dedicated tools exist

No CTMS covers communication

Sources: Tufts CSDD (n=3,970 CRAs, 18 companies) · ACRP 2025 (n=157) · ACRO RBQM Survey 2024 (n=3,758 studies)

The Solution

One System. Complete Lifecycle.

CCIS manages every clinical communication through an end-to-end workflow — automated classification, smart drafting, deadline tracking, and tamper-evident audit trails.

Receive

→

Classify

→

Draft

→

Send

→

Track

→

Audit

🎯

Smart Classification

9 communication categories with AI-assisted scoring. Confidence levels and reasoning shown for every classification per EU AI Act.

✏️

Response Drafting

Top 3 pre-approved text blocks suggested by category, study phase, and language. Placeholders auto-filled from site data.

⚠️

Safety Deadline Tracking

EU MDR Article 87 visual countdowns — 2, 10, 15 day deadlines. Impossible to overlook, color-coded by urgency.

🔇

Silent Site Detection

Automatic alerts when sites exceed communication thresholds. Catch silence before it becomes a compliance risk.

📋

Hash-Chained Audit Trail

Append-only, SHA-256 linked records. Any tampering breaks the chain — automatic detection. One-click CSV export.

👥

Three User Levels

CRA daily operations, Manager portfolio oversight, Safety Officer signal monitoring. Role-based access with read-only safety view.

The Impact

What Changes With CCIS

~2 hrs

Recovered per CRA per day

Communication + tracking overhead eliminated

~25%

Working time returned

Back to actual monitoring work

100%

Audit coverage

Every action logged automatically

0

Missed deadlines

Visual countdowns with escalation alerts

Compliance & Validation

Built for Regulated Environments

🇪🇺

EU Regulatory Framework

  • ✓ EU MDR 2017/745 — Article 87 safety reporting with 2/10/15-day deadline tracking, PMCF communication management
  • ✓ EU AI Act — Rule-based classifier (not ML), full transparency, human-in-the-loop for safety categories
  • ✓ GDPR — Data residency, pseudonymization support
  • ✓ ICH GCP E6(R3) — Electronic essential records, validated system

🇺🇸

FDA Regulatory Framework

  • ✓ 21 CFR Part 11 — Append-only audit trails, e-signatures with meaning/re-authentication/manifestation
  • ✓ FDA GMLP — Transparent, human-in-the-loop AI with documented reasoning
  • ✓ HIPAA-ready — No patient data stored, communication metadata only
  • ✓ FDA QMSR (ISO 13485) — Aligned quality management approach

✔️

GAMP 5 Category 5 Validated

Full validation suite — URS, FS, DS, IQ, Risk Assessment (FMEA), Traceability Matrix, SOP. 215 automated tests. Aligned with FDA Computer Software Assurance (2025).

🔒

Hash-Chained Audit Trail

Meets both FDA Part 11 §11.10(e) and EU Annex 11 requirements. SHA-256 linked, append-only records. Tampering breaks the chain — automatic detection.

Under the Hood

Technical Architecture

⚡

FastAPI

Python 3.12

🔄

HTMX

Partial updates

🎨

Tailwind CSS

Utility-first

🗄️

SQLite

SQLAlchemy ORM

Alpine.js for client interactivity · Plotly.js for charts · Caddy for auto-HTTPS · Docker Compose deployment

See It In Action

The full system is running live. No installation needed.

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