Philips IGT-D · Clinical Operations
The first purpose-built platform for managing clinical trial communication — from intake to audit-ready export.
368
Tests
47
Controlled Docs
14
Regulatory Areas
28
Risks Mitigated
0
New Hires Needed
Phase 1
Complete
Ready
Sandbox Pilot
The Challenge
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
~30%
CRO turnover (2022 peak)
3x healthy rate — BDO 2024 CRO survey
Zero
Dedicated tools exist
No CTMS covers communication
Sources: Tufts CSDD CRA workload benchmark (n=3,970, 2012) · ACRP 2025 (n=157) · ACRO RBQM Survey 2024 · turnover: BDO 2024
The Solution
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
~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
🇪🇺
EU Regulatory Framework
🇺🇸
FDA Regulatory Framework
✔️
GAMP 5 Category 5 Validated
Full validation suite — URS, FS, DS, IQ, Risk Assessment (FMEA), Traceability Matrix, SOP. 368 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
⚡
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
For Decision Makers
A 19-slide presentation that tells the CCIS story through two personas — Sarah the CRA drowning in communication overhead, and Thomas the Manager who needs portfolio visibility. Covers EU & FDA compliance, ROI with team/FTE cost breakdowns across all 3 phases, and the sandbox pilot proposal.
👩💼
Sarah's Story
A CRA managing 12 PMCF sites — the daily reality of communication chaos and how CCIS transforms it
👨💼
Thomas's View
A Clinical Operations Manager who needs portfolio oversight, compliance proof, and team workload visibility
📊
Business Case
Full ROI breakdown with team/FTE costs across Phase 1 (pilot), Phase 2 (department), and Phase 3 (enterprise)
The full system is running live. No installation needed.