Philips IGT-D · Clinical Operations
Clinical Communication Intelligence System
Intelligent communication management for medical device clinical trials — from first-in-human to post-market surveillance
The Context
Class IIb/III
IGT-D device portfolio under EU MDR — each requiring continuous post-market follow-up
10-30+
Clinical sites per PMCF study, with ongoing registries spanning 50+ sites globally
Growing
Every new device variant and site added increases communication volume proportionally
Azurion, IntraSight, ClarityIQ — each platform generates ongoing clinical communication across multiple sites, investigators, and regulatory stakeholders. Under EU MDR, the post-market surveillance obligation is continuous, not one-time.
The Opportunity
Source: Tufts CSDD, n=3,970 CRAs across 18 companies
25-35% of CRA time is communication-adjacent — admin tasks plus off-site coordination. Not a crisis — an optimization opportunity.
The Math
Manual Process
~12 min
per communication response
With CCIS
~4 min
per communication response
15-20 site communications per day × 8 minutes saved = 2-3 hours recovered daily per CRA
The Solution
CCIS manages every clinical communication from intake to audit-ready export
Receive
Intake & classify
Classify
9 categories, AI-assisted
Draft
Text blocks + adaptation
Send
Outlook integration
Track
Deadlines & status
Audit
Hash-chained trail
L1 — CRA
Daily operations: priority queue, drafts, site management
L2 — Manager
Portfolio oversight: CRA performance, enrollment, escalations
L3 — Safety
Signal monitoring: EU-MDR compliance, trends, read-only
CRA View
Everything Sarah needs to know in one view — priority-sorted, color-coded, one-click action
Open Items
12
Pending Reviews
3
Open SAEs
1
Overdue
0
SAE — Day 14/15
Site 04 Hamburg · 1 day remaining
Complaint Triage
Site 07 Lyon · Unclassified
Silent Site — 23 days
Site 02 Amsterdam · Re-engage
Protocol Deviation
Site 06 Milan · Notification
Efficiency
🎯
Context-Ranked
Top 3 text blocks suggested based on category, study phase, and language match
✍️
Style-Adapted
Each CRA's formality, detail level, and tone preferences applied automatically
📊
Audit-Tracked
Edit distance measured between template and final draft — complete transparency for inspections
The 3-Panel Workflow
LEFT: Context
Incoming message, classification, site info, confidence score
CENTER: Suggestions
Top 3 pre-approved text blocks ranked by match score
RIGHT: Draft Editor
Auto-filled placeholders, editable, approve & send to Outlook
Compliance
Not because you miss deadlines — because tracking them shouldn't require spreadsheets.
2
calendar days
Serious public health threat
10
calendar days
Death or serious deterioration
15
calendar days
Other reportable incidents
Visual countdown timers — impossible to overlook, color-coded by urgency
Awareness date immutable after creation — tamper-proof audit protection
Structured status lifecycle: open → in progress → reported → closed
Silent site detection — automatic alerts when sites stop communicating
Visibility
CRA
"What needs my attention now?"
· Priority queue — action required
· Communication inbox with filters
· Smart draft workflow
· SAE countdown tracking
· Site management
Manager
"Who is behind? What needs escalation?"
· Portfolio overview
· CRA performance summary
· Overdue escalation list
· Enrollment progress tracking
· Site drill-down
Safety Officer
"Are we inside all regulatory timelines?"
· Safety event signals
· EU-MDR compliance status
· Trend analysis (12-month)
· Communication volume charts
· Read-only — no accidental edits
Inspection Readiness
Hash-Chained Audit Trail
Every action creates an append-only record linked by SHA-256 hash chain. If any record is altered, the chain breaks — automatic tamper detection.
One-Click Export
PDF or CSV export with system version footer, timestamp, and record count. Ready for regulatory submission.
GAMP 5 Category 5
Full validation suite: URS, FS, DS, IQ, OQ, Risk Assessment (FMEA), Traceability Matrix, SOP, Validation Summary. 215 automated tests.
EU AI Act Compliant
Rule-based classifier with full transparency: method, version, confidence, reasoning shown on every classification. Human-in-the-loop for safety categories.
EMA's #1 inspection finding: documentation deficiencies. CCIS makes documentation the default, not an afterthought.
Market Position
The $2.4B CTMS market focuses on trial management, data capture, and document storage. Nobody builds for clinical communication management.
| Capability | Veeva Vault | Medidata | Oracle | CCIS |
|---|---|---|---|---|
| Trial management | ✓ | ✓ | ✓ | — |
| EDC / data capture | ✓ | ✓ | ✓ | — |
| eTMF / document mgmt | ✓ | ✓ | ✓ | — |
| Communication tracking | — | — | — | ✓ |
| Auto-classification | — | — | — | ✓ |
| Smart response drafting | — | — | — | ✓ |
| Safety deadline tracking | — | — | — | ✓ |
| Silent site detection | — | — | — | ✓ |
CCIS doesn't compete with CTMS platforms — it fills the gap they leave.
Scalability
15-20%
CRA communication capacity recovered
Source: eTMF/CTMS implementation benchmarks
0.5-1.0
FTE equivalent saved across a team of 6
Conservative calculation
6-9
Weeks to pilot deployment
Focused tool, not enterprise CTMS
Each new PMCF study adds ~15-20% communication overhead. Today, that means proportionally more CRA time. With CCIS, the overhead is absorbed through standardized workflows, automated classification, and template-based drafting.
The question isn't whether the team can handle today's workload. It's whether the team can handle next year's portfolio growth without growing proportionally.
Next Steps
Scope
Success Metrics
Requirements
Timeline
Live Demo
The full CCIS demo is running right now. No installation. No setup. Just click.
Built with FastAPI · HTMX · Tailwind CSS · SQLite
GAMP 5 validated · 215 automated tests · EU AI Act compliant
CCIS — Clinical Communication Intelligence System
Philips IGT-D · Clinical Operations