Production
SC
187
Subjects Enrolled
+12 this month
5
Open Deviations
+2 this week
3
Active CAPAs
6
Active Rules
2
Overdue Reminders
91%
Compliance Score

📈 Enrolment Progress by Site

58.4% overall
Site 101 — Guy's Hospital, London 48/60 (80%)
80%
Site 102 — Christie, Manchester 42/60 (70%)
70%
Site 103 — Queen Elizabeth, Birmingham 38/70 (54%)
54%
Site 104 — Royal Marsden, Surrey 35/65 (54%)
54%
Site 105 — Beatson, Glasgow 24/65 (37%)
37%

🧠 Study Brain — ONCO-301

6
Active Rules
3
Decisions Logged
1
Open Questions
2
Pending Reminders
Latest Decision: Switch from paper to ePRO for Patient Diary
Latest Q&A: IP storage temp range (answered)
Flagged Rule: Site 105 enrolment rate below threshold

📝 Recent Activity

Today 10:32 — CRITICAL
SAE Reported — Site 103, Subject 103-024
Grade 3 pneumonitis, related to IP. 24h reporting clock started.
Today 09:15 — HIGH
Rule Triggered: Enrolment Rate Monitor
Site 105 below 2 subjects/month for 2nd consecutive month. Flagged for review.
Yesterday 16:45
CAPA Closed — CAPA-003: CRC Training Gap
Effectiveness check confirmed: query rate reduced from 18% to 7%.
Yesterday 14:20
Decision Logged: ePRO Transition
Paper diary compliance below 60%. Transitioning to ePRO.
6
Active Rules
1
Critical
2
High
3
Medium
14
Total Executions

⚠️ SAE Reporting Window

CRITICAL SAFETY Active

All SAEs must be reported within 24 hours. If not confirmed as reported by hour 18, escalate to Medical Monitor.

Trigger: Event — sae.detected
Applies to: CRA, Site PI, Clinical Lead
Executed: 2 times
Actions:
1️⃣ REMIND → Site PI at 18h: "SAE reporting confirmation required — 6 hours remaining"
2️⃣ ESCALATE → Medical Monitor: "SAE at {site_id} not confirmed within 18 hours"
3️⃣ LOG DECISION: "SAE escalation triggered"

📉 Enrolment Rate Monitor

HIGH ENROLMENT Active

If any site enrols fewer than 2 subjects per month for 2 consecutive months, flag for review.

Trigger: Threshold — enrolment_rate < 2
Applies to: All sites
Executed: 3 times
⚠️ Last triggered: Site 105 (Beatson, Glasgow) — 1.4 subjects/month, below threshold for 2nd consecutive month.

📋 Protocol Deviation Follow-Up

HIGH REGULATORY Active

Every deviation must have a CAPA assigned within 14 calendar days.

Trigger: Event — deviation.created
Applies to: All roles
Executed: 5 times

⏱️ Data Entry Timeliness

MEDIUM DATA QUALITY Active

Source data must be entered within 5 business days of the visit.

Trigger: Threshold — data_entry_lag > 5 days
Applies to: All sites
Executed: 4 times

🏥 Monitoring Visit Overdue

MEDIUM OPERATIONAL Active

If a site has not had a monitoring visit in 8 weeks, flag and schedule.

📄 ISF Document Currency

HIGH REGULATORY Active

ISF documents must be current version. If version mismatch detected, flag for update.

Amendment 3 — Addition of Cohort B (PD-L1 < 1%)

HIGH IMPACTSTUDY-SPECIFIC

Decision to expand enrolment to include PD-L1 negative patients based on interim biomarker analysis.

Decided ByDr. Sarah Chen (PI)
RationaleInterim analysis showed signal in PD-L1 low/negative subgroup. Statistical power supports expanded cohort.
Options ConsideredMaintain current protocol / Add Cohort B ✓ / Open new protocol
Protocol RefSection 5.2 — Patient Population
Regulatory BasisICH E6(R2) §5.18
Review Date15 July 2026
Action Items: Submit amendment to MHRA • Update site feasibility • Recalculate sample size

Site 104 — Corrective Action for Data Quality

MEDIUM IMPACTDATA QUALITY

Implement additional source data verification at Site 104 following 3 query rate exceedances.

Decided ByMark Williams (QA Manager)
RationaleQuery rate exceeded 15% for 3 consecutive months. Root cause: insufficient CRC training on EDC.
Options ConsideredAdditional training only / Training + increased SDV ✓ / Site closure

Switch from Paper to ePRO for Patient Diary

MEDIUM IMPACTOPERATIONAL

Transition from paper patient diaries to electronic PRO for remaining subjects.

Decided ByDEOX Clinical Operations
RationalePaper diary compliance below 60% at 4 of 5 sites. ePRO shown to improve compliance to 85%+.
EvidenceCompliance analysis report 2026-03-15, Vendor ePRO capability assessment
Action Items: Select ePRO vendor • Submit amendment • Train sites • Rolling 4-week transition
3
Total Questions
2
Answered
1
Open

❓ Do we need Competent Authority approval before implementing the safety letter update?

OPEN
Asked by: Regulatory Affairs Team
Type: Regulatory
Priority: HIGH
⚠️ Awaiting answer — blocking safety letter distribution

✅ Can we enrol subjects with controlled brain metastases under Amendment 3?

ANSWERED
Asked by: Dr. James Park (Site 103 PI)
Type: Protocol
Site: SITE-103
Answer (Dr. Sarah Chen): Yes — Amendment 3 Section 5.3 now excludes only untreated or progressive brain metastases. Controlled brain mets (stable for ≥4 weeks post-treatment) are eligible.
Protocol reference: Section 5.3 — Exclusion Criteria

✅ What is the acceptable IP storage temperature range at sites without continuous monitoring?

ANSWERED
Asked by: Lisa Thompson (CRA)
Type: Technical
Site: SITE-105
Answer (Clinical Supply Manager): 2-8°C. Sites without continuous monitoring must check and record temperature twice daily (AM/PM) per Pharmacy Manual §4.2. Any excursion >8°C for >30 minutes must be reported as a deviation.
1
Critical
2
Major
2
Minor
3
Open
2
Closed
IDDescriptionSiteCategorySeverityStatusCAPADays Open
DEV-001Subject 104-012 received wrong dose (320mg vs 240mg)Site 104Dosing Error CriticalUnder InvestigationCAPA-00112
DEV-002Missed PK sample window at Visit 6Site 101Protocol MajorOpen—8
DEV-003IP storage temp excursion 10.2°C for 45 minSite 105IP Handling MajorCAPA AssignedCAPA-00215
DEV-004Missing source doc for AE assessmentSite 103Documentation MinorClosedCAPA-003—
DEV-005IEL not completed within 30 days of SIVSite 102Regulatory MinorClosed——

CAPA-001: Dosing Error Root Cause

IN PROGRESSCritical
Deviation: DEV-001
Owner: Mark Williams (QA)
Site: Site 104
Due: 28 Apr 2026
Root Cause: Protocol amendment dosing table not updated in site ISF. Pharmacy referred to outdated version.
Corrective Action: Re-verify ISF at all sites, implement version-controlled dosing reference cards.
Preventive Action: Mandatory ISF version check in monitoring visit checklist.
65% complete

CAPA-002: IP Temperature Excursion Prevention

IN PROGRESSMajor
Root Cause: Site 105 pharmacy fridge thermostat malfunction. No continuous monitoring installed.
Corrective Action: Install continuous temperature monitoring with SMS alerts at Site 105. Verify at all other sites.
40% complete

CAPA-003: CRC Training Gap — Source Documentation

CLOSEDMinor
Root Cause: New CRC at Site 103 not trained on source documentation expectations.
Effectiveness: ✅ Query rate reduced from 18% to 7% post-training.
100% — Verified

🎲 Risk Matrix

1
2
3
4
5
2
4
6
8
10
3
6
9
12
15
4
8
12
16
20
5
10
15
20
25
↑ ProbabilityDetectability →

📊 Key Risk Indicators

58%
Enrolment
75%
Data Quality
92%
Protocol Compliance
88%
Safety Reporting
IDRisk DescriptionCategoryRPNLevelMitigationReview
RISK-001Site 105 enrolment failure — target unreachableEnrolment18HighEnhanced recruitment strategy + community outreach7 days
RISK-002Data query backlog impacting database lockData Quality12MediumAdditional DM resource + weekly query blitz30 days
RISK-003IP supply chain disruption (single supplier)Supply Chain10MediumIdentify backup supplier + 3-month buffer stock30 days
RISK-004Key PI departure at Site 101Personnel8LowSub-I succession plan documented90 days
91%
Overall Score
22/24
Items Passed
1
Items Failed
1
N/A

MHRA GCP Inspection Readiness — Section Results

Trial Master File: 8/9 passed
89%
Essential Documents: 6/6 passed
100%
Informed Consent: 5/5 passed
100%
Safety Reporting: 3/4 passed
75%
TimestampWhoActionModuleDetailImportance
20 Apr 10:32Dr. S. ChenSAE ReportedSafetySubject 103-024, Grade 3 pneumonitisCritical
20 Apr 09:15SystemRule TriggeredStudy RulesEnrolment rate below threshold — Site 105High
19 Apr 16:45M. WilliamsCAPA ClosedCAPACAPA-003 effectiveness verifiedStandard
19 Apr 14:20Clinical OpsDecision LoggedStudy RulesePRO transition approvedStandard
19 Apr 11:30L. ThompsonDocument GeneratedDocumentsMonitoring Visit Report — Site 102Standard
18 Apr 16:00Dr. J. ParkSignature ExecutedE-SignaturesSigned Form 1832 for Subject 103-022Critical
18 Apr 10:45SystemDeviation CreatedDeviationsDEV-005: IEL not completed within 30 daysHigh
17 Apr 15:20Data ManagerData Query RaisedData QualityMissing lab results — Subject 101-008, Visit 4Standard
Showing 8 of 19 entries • CSV export available with all filters applied
StaffRoleTrainingStatusCompletedExpiry
Dr. Sarah ChenPIGCP CertificateCurrent15 Jan 202615 Jan 2028
Dr. James ParkSite PIProtocol-Specific TrainingCurrent02 Feb 2026—
Lisa ThompsonCRAMonitoring TrainingCurrent10 Mar 2026—
Mark WilliamsQA ManagerAuditing & InspectionExpiring Soon20 Apr 202520 Apr 2026
Emma RobertsCRCEDC TrainingCurrent28 Feb 2026—
Tom HarrisData Manager21 CFR Part 11Not Started—Required by 30 Apr
ObligationAuthorityDue DateStatusDaysAssignee
DSUR Annual Safety ReportMHRA15 Jun 2026Due Soon56 daysSafety Team
Amendment 3 SubmissionMHRA25 May 2026In Progress35 daysRegulatory
Annual Protocol ReviewSponsor01 Aug 2026Upcoming103 daysMedical Monitor
Site 105 Feasibility Re-assessmentInternal30 Apr 2026Overdue-10 daysClinical Lead
Ethics Committee Annual UpdateREC01 Sep 2026Upcoming134 daysRegulatory
28
Total Modules
25
Active
3
Beta
59
API Endpoints

🔐 Authentication & RBAC

JWT authentication, role-based access control, API key management with SHA-256 hashing.

ActivePhase 1

🧠 NLU Router v2.0

26-module natural language classification with GLM AI + local fallback. Routes queries to correct module.

ActivePhase 1

🗺️ Process Navigator

7 clinical workflows: Study Setup, Site Initiation, Enrolment, Monitoring, Safety, Close-Out, Archival.

ActivePhase 1

📄 Document Generator

Template-driven document generation with protocol, report, and letter templates.

ActivePhase 1

🔴 Deviation & CAPA Tracker

Full deviation lifecycle, root cause analysis, CAPA management with effectiveness checks.

ActivePhase 2

✍️ E-Signatures (21 CFR Part 11)

Compliant electronic signatures with meaning codes, audit trail, and signature manifestations.

ActivePhase 2

📝 Audit Programme

Inspection preparation, audit scheduling, finding tracking, and CAPA linkage.

ActivePhase 2

📊 Quality Dashboard

Interactive quality metrics with KRI gauges, risk matrix, and enrolment tracking.

ActivePhase 2

📧 Notification Bridge

Email, Outlook Calendar, Google Calendar, MS Teams, Discord notifications.

ActivePhase 2

🔗 Integration Connectors

Veeva Vault, Medidata Rave, Oracle Clinical, and 7 more. Adapter-based configuration.

ActivePhase 2

⚠️ Risk Assessment Engine

ICH Q9 / ISO 14971 risk scoring (P×I×D), KRI monitoring, automated review scheduling.

ActivePhase 3

✅ Compliance Engine

Pre-built MHRA GCP, EMA GCP, FDA 21 CFR Part 11 checklists with 68 items.

ActivePhase 3

📝 Audit Trail v2

40+ action labels, CSV export, importance classification, inspection-ready format.

ActivePhase 3

⚙️ Study Rules Engine

Per-study configurable rules, decision logs, Q&A logs, reminders, escalation chains.

ActivePhase 3

🏥 Tenant Onboarding

Self-service registration, plan selection, automatic D1 provisioning, welcome workflows.

ActivePhase 3

💾 Backup & Recovery

Full export/import, disaster recovery, point-in-time restore, encrypted archives.

ActivePhase 3

🎓 Training Tracker

Certification management, expiry tracking, role-based training requirements.

ActivePhase 3

📅 Obligation Tracker

Regulatory calendar, authority-specific deadlines, automated reminders.

ActivePhase 3

🔄 Change Control

Change management workflow, impact assessment, approval routing.

ActivePhase 3

🚦 Rate Limiter

Token bucket per tenant+endpoint, 4 plan tiers, 4 endpoint categories.

ActivePhase 3

📋 SOP Import

SOP parsing, registration, and version management from uploaded documents.

ActivePhase 3

🏥 Health Monitor

Module registry, system readiness checks, uptime tracking for all 28 modules.

ActivePhase 3
5
Templates Available
12
Sections Generated
3
Drafts In Progress
1
Pending Review

🔬 Protocol Skeleton Builder

Enter basic drug and study information. The AI will generate a full protocol skeleton including schedule of assessments, study design, cohort structure, and loose statistics.

📐 Complexity Score

Generate a protocol to see its complexity score, recruitment risk, and patient burden analysis.

📅 Schedule of Assessments

Generate a protocol to see the optimised visit schedule with timing, windows, and assessments per visit.

8
Document Templates
24
Content Requirements Mapped
15
Winning Statements
2
Pending Submissions

📜 Regulatory Document Builder

Select document type and provide context. The AI generates required sections, mandatory statements, and content angles needed to win applications.

🎯 Required Content Angles

Select a document type to see the mandatory content sections, required statements, and criteria you must address to win approval.

✅ Submission Criteria Checklist

Select a document type to generate a complete checklist of regulatory criteria, acceptance requirements, and common rejection reasons.