🔔 AI Alert — Day 232 (20 Apr 2026)
2 Overdue
1 At Risk
3 Insights
47
Subjects Enrolled
+8 in Feb
39%
Enrolment Progress
5
Deviations
3 Major
3
SAEs Reported
4
Open Queries
94%
TMF Complete
2
CAPAs
1 open
6.3d
Avg Query Resolution
📈 Enrolment by Month
47/120🏥 Site Performance Summary
| Site | Enrolled | Active | SDV% | Compliance |
|---|
📝 Recent Activity
🎯 Upcoming Milestones
| Milestone | Date | Status |
|---|
⚠️ Risk Watch Summary
💡 AI Insights
6
Active Sites
47
Total Enrolled
39%
Overall Enrolment
88%
Avg SDV
2
Sites At Risk
⚠️ Site-Specific Risks
3
Total SAEs
2
Related to IP
3
Recovered
0
Open SAEs
📊 SAE Trending by Mechanism of Action
📈 SAE Timeline & Reporting Compliance
🔬 SAE Detail Cards
All Require Review
⚠️ Safety-Specific Risks
3
Major
2
Minor
2
CAPA Linked
3
Closed
2
Open
📊 By Site
📈 By Type
⏱ Timeline
| ID | Description | Site | Type | Severity | Status | CAPA |
|---|
2
Total CAPAs
1
Open
1
Closed
43d
Avg Closure
1
Overdue
📅 CAPA Timeline
🔗 Linked Deviation Chain
5
CTQ Factors
3
QTLs Breached
14
Active KRIs
7
Protocol Deviations
4
Actions Taken
3
Actions Pending
🎯 CTQ → QTL → KRI Cascade
📋 KRI Signal Summary
| KRI | CTQ | QTL Threshold | Current | Signal | Associated PDs | Actions Taken | Actions Pending |
|---|
⚡ Action Tracker — Risk-Linked
| Action ID | Linked KRI | Linked PD | Action | Owner | Due | Status |
|---|
| ID | Risk | Score | Level | Status | Category |
|---|
| Timestamp | Who | Action | Module | Detail | Importance |
|---|
6
Active Rules
1
Critical
2
High
10
Active Obligations
2
Overdue
3
Submitted
15d
Next Deadline
Regulatory Obligation Tracker
| ID | Type | Description | Authority | Due Date | Status | Risk | Actions |
|---|
Obligation Calendar
5
Pending Review
12
Approved
1
Rejected
2.1d
Avg Turnaround
Approval Queue — 21 CFR Part 11 Compliant
| Submission ID | Document Type | Title | Classification | Submitted By | Submitted | Status | Actions |
|---|
Document Classification Guide
Approval Workflow
94%
TMF Completeness
68
Checklist Items
4
Templates Available
12
Gaps Identified
TMF Zone Completeness
Inspection Readiness Checklists
Gap Analysis Summary
| Milestone | Target Date | Status | Countdown |
|---|
28
Platform Modules
59
API Endpoints
3
Build Phases
💡 Quick Capture
Type an idea, change, or thought. The system auto-detects which document it relates to.
8
Total Captured
1
Critical
3
High
3
Medium
1
Idea
| ID | Change Idea | Target Doc | Category | Priority | Author | Status |
|---|
🧠 AI Working Memory — Today's Digest
Auto-generated from all study activity. Updated continuously as events occur.
232
Days Running
8
Events Today
1
Overdue Actions
3
Predictions
⚠️ Urgent Actions
🔮 Predictions
📊 Key Trends
💡 AI Recommendations
🔗 Cross-Referenced Insights
📅 Mock Day Simulation
Select a day to see how the AI ingested events and generated intelligence.
📋 Active Plans & Strategies
All current strategies, action plans, CAPAs, amendments, and improvement initiatives in one view.
6
Active Plans
1
Overdue
3
On Track
2
At Risk
| Plan | Type | Owner | Status | Progress | Due | AI Note |
|---|
📥 CRO Data Ingestion & Modelling
CRO metrics are ingested from data exports (CSV/JSON) and modelled by the AI. Live database integration is on the roadmap — for now, the AI models metrics from CRO-provided data.
📤 Upload CRO Data
Drop a CSV/JSON export from your CRO to ingest and model metrics.
📁
Click to upload CSV/JSON
📊 Last Ingestion
Source: DEOX Clinical Ltd (CRO)
Format: JSON metrics export
Ingested: 2026-04-20 06:00 UTC
Records: 847 data points
Quality Score: 94%
Gaps detected: 2 (Site 105 visit 4 labs pending)
🔄 Modelled Metrics from CRO Data
These metrics are computed by the AI from CRO data exports, not from live database connections.
| Metric | Value | Trend | AI Assessment |
|---|
🧠 CRO Data Quality Assessment
📂 Document Ingestion Engine
Upload anything. CSV, Excel, PDF, Word, JSON, XML, images, emails, HL7/FHIR messages. The AI classifies it, extracts data, validates it, and feeds it into the study brain.
20
File Types
47
Docs Ingested
1,847
Records Extracted
94%
Validation Rate
📤 Upload Any File
📂
Drop any file here or click to upload
CSV, XLSX, PDF, DOCX, JSON, XML, PNG, JPG, EML, HL7, ZIP, and more
📊 CSV
📊 XLSX
📄 PDF
📝 DOCX
📋 JSON
📋 XML
🖼️ PNG/JPG
📧 EML/MSG
🏥 HL7/FHIR
📦 ZIP
+ 9 more
🔀 Data Sources
CRO System Exports28 docs
Manual Uploads12 docs
API Integrations5 docs
Email Capture2 docs
Pipeline: Upload → Classify → Extract → Validate → Store → Index → Feed to Brain
📋 Recent Ingestions
| File | Auto-Classified As | Source | Records | Validated | AI Action |
|---|
🧠 AI Classification Engine
The system auto-detects document types from filenames and content. Here's what it can recognise:
🧪 Ingestion Pipeline Demo
See how a real file gets processed end-to-end.
12
Active Shipments
847
Units Received
23
Units Quarantined
96.2%
Accountability Rate
1
Temp Excursions
156
Units Dispensed
💊 IMP Batch Register
| Batch ID | Product | Strength | Qty Received | Qty Dispensed | Qty Returned | Qty Destroyed | Status | Expiry | Site |
|---|
🚚 Shipment Log
| Shipment ID | Batch | From | To Site | Shipped | Received | Condition | Temp (°C) | Status |
|---|
🌡️ Temperature Monitoring
| Storage Unit | Location | Current (°C) | Range | Last Reading | Excursions (30d) | Status |
|---|
📂 Investigator Site File (ISF)
Site-level document management. Each site maintains its own ISF with regulatory, staff, consent, and source documents. ISF = site-level | eTMF = sponsor-level
157
Total Documents
127
Filed
14
In Review
4
Missing
90.2%
ISF Completeness
6
Active Sites
🏥 Per-Site ISF Summary
📂 ISF Zone Navigator
📄 Document Registry
| Doc ID | Title | Zone | Status | Version | Filed | Owner | Actions |
|---|
🔍 Inspection Readiness
🚨 Missing Documents Alert
📅 Filing Timeline (Recent)
🔽 Enrolment Funnel
📈 Monthly Enrolment vs Target
🏥 Site Comparison
🔍 Query Analytics
⚠️ Safety Signal Timeline
📊 KPI Scorecard
196
Total Documents
174
Filed
14
In Review
8
Missing
87%
Overall Completeness
📁 eTMF Zone Navigator
📋 Document Registry
| ID | Title | Zone | Sub | Status | Version | Filed | Owner |
|---|
🔍 Inspection Readiness
⚠️ Missing Documents
📅 Filing Timeline
📝 AI Document Generator
📊 Document Pipeline
18
Documents in Pipeline
5
In Draft
4
In QC Review
3
Pending Approval
6
Approved This Month
🎯 CTQ Cascade — Critical-to-Quality Hierarchy
📊 KRI Signal Table
| KRI | CTQ | Threshold | Current | Signal | PDs | Actions Taken | Actions Pending |
|---|
⚡ Risk Action Tracker
| Action ID | KRI | PD Ref | Action | Owner | Due | Status |
|---|
🔴 Due Today / Overdue
📅 This Week
📋 All Tasks
| Task | Freq | Owner | Due | Priority | Status | Linked |
|---|
🎯 Goals & Milestones
📅 Goal Timeline
📋 Regulatory Submissions
| Ref | Type | Description | Submitted | Status | Approved | Conditions |
|---|
🏥 Site Regulatory Status
| ID | Site | PI | Status | Enrolled | Last MV | Next MV | Compliance |
|---|
🚀 Site 106 Startup Checklist
📝 Protocol Amendments
| ID | Title | Status | Submitted | Approved | Sites |
|---|
🏛️ MHRA Communication Log
📋 Plan Registry
| ID | Title | Version | Status | Owner | Last Review | Next Review | Linked |
|---|