Overview
DEOX-MOCK-001 � Phase II NSCLC � NovaCura Biotech
Checking API...
DEMO
DU
Demo User
Total Sites
—
Active Subjects
—
Open Queries
—
SAE Count
—
Enrolment Trend
—
Enrolment by Month
47/120Site Performance Summary
| Site | Enrolled | Active | SDV% | Compliance |
|---|
Recent Activity
Upcoming Milestones
| Milestone | Date | Status |
|---|
Risk Watch Summary
AI Insights
0
Total Contacts
0
Principal Investigators
0
Coordinators
0
CRAs / Monitors
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 MoA
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 | Actions |
|---|
0
Total CAPAs
0
Open / In Flight
0
Closed / Verified
0
Avg Closure
0
Overdue
5
CTQ Factors
3
QTLs Breached
14
Active KRIs
7
Protocol Deviations
4
Actions Taken
3
Actions Pending
Risk Matrix (Impact � Likelihood)
Likelihood ?
Impact ?
Low
Medium
High
Critical
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 |
|---|
847
Entries This Month
5
Active Users
Sites (312)
Most Changed Entity
2026-04-28
Last Audit Review
23
Critical Changes
Electronic Signature Log (21 CFR Part 11)
| Signatory | Role | Document / Action | Signed Date | Meaning | Status |
|---|
6
Report Templates
7
Reports Generated
2
Active Schedules
4
Report Types Used
Report Templates
Click Generate to create a report from current study dataReport History
| Date | Report Type | Generated By | Format | Size | Status |
|---|
Scheduled Reports
Automated report generation and distribution| Report | Frequency | Schedule | Recipients | Status | Actions |
|---|
Obligation Tracker
| ID | Obligation | KRI Ref | Due Date | Risk Level | Status | Owner |
|---|
Approval Queue - 21 CFR Part 11 Compliant
| Submission ID | Document Type | Title | Classification | Submitted By | Submitted | Status | Actions |
|---|
Document Classification Guide
Approval Workflow
Electronic Signature Log - 21 CFR Part 11
| Timestamp | Approval | Action | Signatory | Role |
|---|
Compliance Checklist
Validation Pack Progress (IQ / OQ / PQ)
Inspection Readiness Score
Gap Analysis Summary
3
Complete
5
On Track
1
At Risk
0
Overdue
67%
Overall Progress
Study Timeline
Milestone Register
| Milestone | Target Date | Actual Date | Status | Category | Owner | Progress |
|---|
Study KPIs
10
Platform Modules
51
API Endpoints
38
Stable
10
Beta
9/10
Integrations
65%
Platform Complete
Change Control
Managed change requests for study documents, processes, and systems.
| ID | Change Title | Type | Category | Priority | Requester | Due Date | Status |
|---|
AI Model Configuration
Knowledge Base
Study Context Loaded
?? Knowledge Graph - Entity Relationships
Interactive map of study entities. Click any node for details, click any edge for relationship context. Drag nodes to rearrange.
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 Registry
| ID | Plan | Version | Status | Owner | Last Review | Next Review | Reminder | Execution |
|---|
Protocol Deviation Management
Risk-Based Monitoring Strategy
Study-Specific Procedures
| Plan | Type | Owner | Status | Progress | Due | AI Note |
|---|
Competitive Intelligence
BENCHMARKEDPerformance Benchmarks - Click any metric to view data sources
CRO Competitive Landscape - Click a row for full profile
CRO Data Ingestion & Modelling
CRO metrics are ingested from data exports (CSV/JSON) and modelled by the AI.
Upload CRO Data
Drop a CSV/JSON export from your CRO.
Click to upload CSV/JSON
Last Ingestion
Source: Kyber Clinical Ltd (CRO)
Format: JSON metrics export
Ingested: 2026-04-20 06:00 UTC
Records: 847 data points
Quality Score: 94%
Modelled Metrics from CRO Data
| Metric | Value | Trend | AI Assessment |
|---|