Philips IGT-D · Clinical Operations
Clinical Communication Intelligence System
Your CRAs lose 2 hours/day to communication chaos.
Your managers make decisions flying blind.
What if that changed tomorrow?
The Invisible Crisis
65%
of a CRA's day is spent on tasks
that aren't monitoring patients
Tufts CSDD · n=3,970 CRAs · 18 companies
32%
CRO turnover
51%
say workload is unmanageable
96%
now use risk-based monitoring
Story One
Home-based CRA · 12 PMCF sites · 6 countries · Class IIb catheter study
7:30 AM — Opens the laptop
38 new emails. Sites, safety, sponsor — all in one inbox. A safety event sits between a training reminder and an expense report.
8:00 AM — System shuffle
CTMS, SharePoint, Excel, safety DB, TMF, Teams. Eight tabs. Copy-paste between systems. Is Hamburg at day 14 or 15?
9:00 AM — Meetings begin
Standup, clinical team call, GCP training, portfolio review. Screen time is relentless — emails keep arriving.
11:30 AM — Still drafting
8 of 22 messages done. Each: find template → adapt → check language → send → update CTMS → file in TMF. The rest waits.
Sarah is excellent at her job. The process is the bottleneck.
Sarah's Day
~65% is communication, meetings, or admin — not monitoring
8+ systems, zero integration
Outlook
no classification
Excel
SAE tracking
CTMS
status updates
SharePoint
templates
TMF
document filing
Safety DB
SAE submissions
Teams
coordination
Tracker
follow-ups
Nothing is classified. Nothing is tracked.
Story Two
Clinical Operations Manager · 6 CRAs · 3 studies · 40+ sites across EU and US
Monday 8 AM — Status check
Five spreadsheets, three outdated. He pieces together a picture that's already 3 days old.
9:30 AM — The dreaded question
"How many open SAEs across all studies?" He doesn't know. "Let me check." It takes 45 minutes.
11 AM — The silent site
Barcelona hasn't responded in 3 weeks. Nobody flagged it. The PI is on leave. Three weeks lost.
2 PM — Audit announced
"Show all communications about this complaint." Two CRAs will spend 2 weeks in Outlook archives.
Thomas has responsibility for everything. Visibility into almost nothing.
Thomas's Reality
SAE Deadlines
Which CRA has a deadline expiring tomorrow? He finds out when it's almost too late.
Unanswered Messages
How many went unanswered this week? No idea until someone complains.
Silent Sites
No alert system. By the time he notices a quiet site, weeks have passed.
Audit Readiness
"Show every communication about this event." Weeks of Outlook archaeology.
Team Capacity
"Can we take on 2 more studies?" He doesn't know who has bandwidth.
Knowledge Loss
A CRA leaves. Six months of context walks out the door. Nothing was captured.
Thomas isn't failing. His tools are.
The Cost of Doing Nothing
~2 hrs
lost per CRA per day
communication admin & system shuffling
100
hours/week vanish
10 CRAs = 2.5 FTEs doing admin
€72–96K
recoverable annually
€60–80/hr fully loaded CRA cost
Compliance risk
Every missed SAE deadline = regulatory breach. Every untracked communication = audit gap. Every admin hour = not monitoring patient safety.
Human cost
32% turnover, 3x healthy rate. Replacing one CRA costs 50–200% of salary. #1 driver: perceived workload.
For Sarah
2 hours back. Every day.
For Thomas
Real-time visibility. Zero digging.
For Compliance
Audit-ready. Every single day.
The Solution
From intake to audit-ready export
Receive
Classify
Draft
Send
Track
Audit Trail
CRA
"What needs my attention now?"
Manager
"Where are my risks?"
Safety Officer
"Are we within timelines?"
Transformation
Before
×8 browser tabs, no priority
×12 min per standard response
×Manual CTMS + TMF updates
×SAE dates in spreadsheets
×"Is Hamburg at day 14 or 15?"
= Risk accumulates silently
With CCIS
✓One dashboard, priority-sorted
✓5 min per response, auto-filled
✓Audit trail generated automatically
✓Visual SAE countdown
✓"Hamburg: Day 14. 1 day left."
= Audit-ready every single day
Transformation
Before
×5 spreadsheets for team status
×45 min to compile SAE overview
×Silent sites found by accident
×Audit prep: weeks of email digging
×CRA leaves = knowledge gone
= Managing by hope, not data
With CCIS
✓One manager dashboard, real-time
✓All SAEs across all studies — instant
✓Silent site alerts — automatic
✓Full communication trail — one click
✓Every interaction captured forever
= From firefighter to strategic leader
"Thomas, how many open SAEs?"
"Three. All within timeline. Here's the dashboard."
That answer used to take 45 minutes. Now: 3 seconds.
Built for Compliance
Not bolted on. Architected in.
EU Regulations
2
days · public health
10
days · death/serious
15
days · other SAE
✓ EU MDR Art. 87 — visual countdown timers
✓ EU AI Act — rule-based, exempt (Art. 3(1))
✓ GDPR + Works Council — DPIA, ROPA, consent
✓ ICH GCP E6(R3) — full compliance mapping
✓ ISO 27001 / NIS2 — STRIDE, BCP
FDA & Quality
✓ 21 CFR Part 11 — hash-chained audit trail, e-sig
✓ GAMP 5 Cat 5 — FDA CSA risk-based, 368 tests
✓ ISO 13485 §4.1.6 — QMS software validation
✓ ALCOA+ — data integrity by design
✓ FDA GMLP — transparent, human-in-the-loop
✓ RBAC 4 roles · No patient data stored
EMA/FDA #1 finding: documentation deficiencies. CCIS makes documentation the default.
Market Position
The €2.4B CTMS market builds for trial management. Nobody builds for clinical communication.
| Capability | Veeva | Medidata | Oracle | CCIS |
|---|---|---|---|---|
| Trial management | ✓ | ✓ | ✓ | — |
| EDC / eTMF | ✓ | ✓ | ✓ | — |
| Communication tracking | — | — | — | ✓ |
| Auto-classification | — | — | — | ✓ |
| Smart drafting | — | — | — | ✓ |
| SAE deadline tracking | — | — | — | ✓ |
| Silent site detection | — | — | — | ✓ |
CCIS doesn't compete with CTMS. It fills the gap they leave.
Proof
It's a working system.
368
automated tests
0 failures
47
controlled docs
DML-001 master list
14
regulatory areas
mapped & compliant
28
risks mitigated
ISO 14971
Security
STRIDE · ISO 27001 / NIS2 · SBOM · BCP
Validation
FDA CSA · GAMP 5 · ISO 13485 · ALCOA+
Privacy
DPIA · ROPA · GDPR + Works Council
Built by a CRA who lives the workflow. Tested like enterprise software. Ready to pilot.
Business Case
~2 hrs
per CRA/day recovered
~25%
working time returned
1–1.5
FTE saved per 6 CRAs
30:1
ROI ratio
| Phase 1 · Sandbox Weeks 1–4 |
Phase 2 · Execute Weeks 5–12 |
Phase 3 · Production Ongoing |
|
|---|---|---|---|
| Infrastructure | €0–30/mo | €50–80/mo | €200–400/mo |
| Project Lead | Part-time alongside CRA duties |
Part-time alongside CRA duties |
20% FTE Product owner |
| Pilot CRAs | — | 2–3 CRAs 30 min/day testing |
— |
| Developer | — | — | 50% FTE internal or dedicated |
| IT Support | ~8 hrs total VM + sandbox setup |
~4 hrs Azure AD registration |
10% FTE existing IT team |
| Quality | — | — | ~3 days formal sign-off |
0 new hires across all phases. All existing staff, part-time.
Enterprise CTMS: €100K–500K+/year
The Other Option
Nothing changes
Sarah keeps losing 2 hours/day. Thomas keeps managing from spreadsheets. Every communication stays unclassified. The inefficiency isn't dramatic — it's normal. That's the danger.
An audit finds it first
A missed deadline. An untracked complaint. "Show me every communication about this safety event." Two CRAs, two weeks, digging through Outlook.
We lose another CRA
At 32% turnover, it's when, not if. Six months of knowledge walks out. Replacement cost: 50–200% of annual salary.
Risk of trying: near zero.
Risk of not trying: compounds every day.
Why Now
Three forces converging. Prepare now = lead. Wait = scramble.
ICH GCP E6(R3) — Traceability becoming mandatory
Systems that can't prove communication traceability face scrutiny. CCIS is built for this.
EU MDR — Auditors finding communication gaps
"Show me all communications about this event" is no longer hypothetical. CCIS answers it in seconds.
FDA CSA (2025) — Risk-based validation is the standard
New guidance favors automated, risk-based approaches. CCIS: 368 tests, GAMP 5 Cat 5.
Today: competitive advantage. Tomorrow: compliance necessity.
The Ask
Not a production commitment. Not an IT project. Not a budget request.
"Can we deploy this on a sandbox VM and have
2–3 CRAs test it for 4 weeks?"
1 VM
Any machine + Docker
3 CRAs
30 min/day during pilot
4 weeks
Telemetry + metrics
€0
No budget needed
Works?
Proceed with data
Partly?
Adapt with learnings
Doesn't?
Delete container. Done.
Zero hires · Zero vendors · Zero IT integration · Fully reversible
Live Demo
The system is running right now. No installation. No setup. Just click.
Sarah
gets her 2 hours back.
Every single day.
Thomas
gets real-time visibility.
Zero digging. Zero guessing.
Compliance
becomes the default.
Audit-ready. Always.
All from one system that's already built, tested, and running.
368 tests · 47 controlled docs · 14 regulatory areas · GAMP 5 validated
CCIS — Clinical Communication Intelligence System
Philips IGT-D · Clinical Operations