v0.3.0 · Production
🔍
🔔 3
SC
187
Subjects Enrolled
▲ +12 this month (+6.8%)
Updated 2 min ago · Target 320 (58%)
5
Open Deviations
▲ +2 this week
2 critical, 1 major, 2 minor
3
Active CAPAs
1 effectiveness check pending
6
Active Rules
14 total executions today
2
Overdue Reminders
Both SAE reporting related
91%
Compliance Score
▲ +3% from last month
Target: 95%

📈 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.

⚙️ Protocol-as-Code Engine

Every criterion in your protocol, SAP, monitoring plan, safety plan, CTP, and vendor contracts is continuously evaluated against live data. Rules trigger automatically when conditions are met — no manual monitoring required.

34
Active Rules
12
Protocol Rules
§ Eligibility · §7 Stopping · §5 Dosing
6
Safety Plan Rules
SAE · SUSAR · DMC
5
Monitoring Plan
SDV · Triggers · Risk-Based
4
SAP Rules
Interim · Futility · DMC
4
Operational
CTP · Enrolment · Data Quality
3
Critical
Auto-escalating now

🔄 Live Data Ingestion Pipeline

Processing

All rules are evaluated in real-time as data enters from any source. Every document, form, database entry, or communication is automatically parsed and matched against active criteria.

🚨
Safety Data
SAE forms · CIOMS · MedWatch
EDC AE entries · Safety DB sync
PCG notifications · Site calls
📊
Clinical Data
EDC entries · Lab results
ePRO data · PK samples
IXRS randomisation · Vital signs
📁
Document & TMF
TMF filings · 1572s · CVs
Protocol amendments · IB updates
Regulatory submissions · IRB docs
💬
Communications
Vendor reports · CRA visit notes
Email ingestion · Meeting minutes
Site query responses · DMC letters
🚨 Safety Plan Rules Source: Safety Management Plan, Protocol §7, DSMB Charter

⚠️ SAE Reporting Window

CRITICAL SAFETY PROTOCOL §7.1 Active
Trigger: sae.ingested (any source)
Source: Protocol §7.1, Safety Plan §3.2
Executed: 2 times
📡 Ingestion: SAE form · CIOMS · EDC AE · TMF · PCG · Safety DB · Site phone call · MedWatch/Yellow Card
1️⃣ Start 24h clock → 2️⃣ REMIND PI at 18h → 3️⃣ ESCALATE Medical Monitor if unconfirmed → 4️⃣ LOG decision

🛑 Treatment Pause — SAE Protocol Stopping Rules

CRITICAL SAFETY PROTOCOL §7.3 Active
Trigger: sae.ingested where grade ≥ 3 AND drug-related
Source: Protocol §7.3 Stopping Rules
Executed: 1 time
📡 Ingestion: Same as SAE rule — any safety data entry triggers evaluation
Protocol criteria auto-evaluated:
• Grade ≥3 + drug-related → PAUSE IP → safety workup → 24h review
• Grade 4/5 any relatedness → STOP IP + urgent safety review
• Immune-related Grade 3 → PAUSE + corticosteroid protocol
• ALT/AST >5x ULN → PAUSE + liver workup
• Pneumonitis + symptoms → PAUSE + CT chest
⚡ Last: Today 10:32 — Site 103, Subject 103-024. Grade 3 pneumonitis. IP paused, CT ordered, review scheduled.

📋 SUSAR Regulatory Reporting

CRITICAL SAFETY SAFETY PLAN §4 Active
Trigger: SAE classified as SUSAR
Source: Safety Plan §4, EU CTR Art 43, MHRA guidance
Executed: 1 time
1️⃣ SUSAR classified → 2️⃣ 15-day MHRA notification starts → 3️⃣ Annual safety report tracker updated → 4️⃣ All investigators notified → 5️⃣ IB update flagged if applicable

📉 DMC Stopping Boundary Monitor

HIGH SAP §5 / DMC CHARTER Active
Trigger: Each DMC unblinding / interim analysis
Source: SAP §5, DMC Charter, Protocol §9
Executed: 0 times (first look at 50% enrolment)
Auto-prepare DMC package: safety summary, efficacy boundaries, futility assessment, enrolment trajectory. Flag if O’Brien-Fleming boundaries approached.
📖 Protocol Rules Source: Protocol §1-12, Informed Consent, Schedule of Assessments

✍️ Eligibility Criteria Guard

CRITICAL PROTOCOL §4 Active
Trigger: Subject screening data entered (EDC/IXRS)
Source: Protocol §4 Inclusion/Exclusion
Executed: 187 times (12 flagged)
📡 Ingestion: EDC screening data · IXRS randomisation attempt · Lab results · Medical history entry · Consent date
Auto-evaluates all 14 inclusion + 22 exclusion criteria against entered data. Blocks randomisation if any exclusion met or inclusion unmet. Flags borderline criteria for PI review. Logs deviation if subject enrolled with unmet criteria.

💊 Dosing Compliance & Window Monitor

HIGH PROTOCOL §6 Active
Trigger: Dose administration logged, PK sample received
Source: Protocol §6 Dosing, SoA §8
Executed: 89 times (3 deviations flagged)
📡 Ingestion: IXRS dose assignment · EDC visit data · Pharmacy logs · PK sample timing · ePRO dosing confirmation
Evaluates: visit window compliance (±3 days), dose modifications per protocol, treatment holds/restarts, PK timing windows, dose reduction criteria. Auto-flags deviations and creates deviation record.

📝 Protocol Amendment Impact Engine

MEDIUM PROTOCOL §AMENDMENTS Active
Trigger: Protocol amendment filed / IRB approval received
Source: Protocol amendments, IRB/Ethics letters
Executed: 2 times
📡 Ingestion: TMF amendment filing · IRB approval letter · Sponsor amendment notification · Email from regulatory
Auto-evaluates amendment impact on: eligibility criteria → update screening rules. Dosing changes → update dosing monitor. SoA changes → update visit windows. New safety criteria → update stopping rules. Notifies affected vendors (CRO, lab, supply) automatically.
🔍 Monitoring Plan Rules Source: Monitoring Plan, Risk-Based Monitoring Strategy, CTP

🎯 Risk-Based Monitoring Trigger Engine

HIGH MONITORING PLAN §3-5 Active
Trigger: Continuous (evaluated against live data)
Source: Monitoring Plan §3 Risk Indicators, §4 Trigger Rules, §5 SDV Strategy
Executed: 8 times
📡 Ingestion: All clinical data (continuous) · Query rates · Deviation rates · SAE rates by site · Enrolment metrics · Data entry timeliness
Auto-adjusts monitoring intensity:
• Site query rate >15% → increase SDV to 100%, add onsite visit
• Site SAE rate >2x expected → triggered monitoring visit + safety review
• Data entry lag >5 days → CRA outreach + escalation to PM
• Consent rate <80% of screened → site retraining flagged
• Deviation rate >3/month at site → CAPA auto-created, focused monitoring

📋 SDV Coverage & Source Data Quality

MEDIUM MONITORING PLAN §5 Active
Trigger: Visit completed / data entered
Source: Monitoring Plan §5 SDV Strategy
Executed: 14 times
Dynamically sets SDV % per site based on risk score. Critical data points (informed consent, primary endpoint, SAEs) always 100% SDV. Non-critical data adjusted per site performance. Auto-generates monitoring visit prep package with flagged items.
📈 Enrolment & Operational Rules Source: CTP, Enrolment Projections, Data Management Plan

📉 Enrolment Rate Monitor

HIGH CTP / PROTOCOL §10 Active
Trigger: IXRS randomisation + monthly threshold check
Source: CTP enrolment targets, Protocol §10
Executed: 3 times
⚠️ Last: Site 105 (Beatson) — 1.4 subjects/month for 2nd consecutive month. Below 2/month threshold. Feasibility review triggered.

⏱️ Data Entry Timeliness

MEDIUM DMP §6 Active
Trigger: Visit date entered, data entry lag calculated
Source: Data Management Plan §6
Executed: 4 times
Source data must be entered within 5 business days. Auto-remind CRC at day 4. Escalate to CRA at day 6. Log deviation at day 8. Adjust site risk score for monitoring plan.

🏥 Monitoring Visit Overdue

MEDIUM MONITORING PLAN §6 Active
Trigger: Scheduled visit date passed without completion
Source: Monitoring Plan §6 Visit Schedule
Executed: 2 times
🏛️ Regulatory & Compliance Rules Source: EU CTR, MHRA Guidance, GCP, Regulatory Strategy

📜 Regulatory Submission Deadline Tracker

HIGH REGULATORY STRATEGY Active
Trigger: Milestone reached / deadline approaching
Source: Regulatory Strategy, EU CTR timelines, MHRA guidance
Executed: 3 times
📡 Ingestion: CTIS updates · MHRA correspondence · Ethics letters · Sponsor milestone tracking
Tracks all regulatory obligations: annual safety report (28 days post DLP), SUSAR notifications (15 days), substantial amendment submissions (CTIS 12-day assessment), annual progress reports, end-of-trial notification (<90 days). Auto-prepares submission packages with required data.

📃 Deviation Classification & CAPA Assignment

HIGH PROTOCOL / GCP Active
Trigger: Deviation identified (any source)
Source: Protocol §11, GCP §4, Monitoring Plan
Executed: 5 times
📡 Ingestion: CRA deviation report · EDC data anomaly · Site self-report · Monitor observation · Vendor notification · Quality audit finding
Auto-classifies severity (critical/major/minor) using protocol criteria. Assigns CAPA category. Creates 14-day CAPA deadline. Links to related rules. Assesses repeat pattern at site/subject level. Determines if IRB notification required (UK: within 15 days for substantial).
🏢 Vendor Oversight Rules Source: Vendor contracts, SLAs, SOWs, Oversight Plan

📊 Vendor SLA Compliance Monitor

MEDIUM VENDOR CONTRACTS Active
Trigger: KPI data received from vendor / milestone date
Source: All vendor contracts & SLAs
Executed: 6 times
📡 Ingestion: Vendor reports · System uptime logs · Milestone tracking · Invoice reconciliation · Quality metrics · Correspondence
Monitors all 8 vendors against contractual SLAs. First breach → Level 1 escalation to vendor PM. Second breach → Level 2 to vendor leadership + sponsor PM. Critical failure → immediate escalation + contract review triggered. Success streaks logged for performance incentives.
Showing 14 of 34 active rules. View all 34 rules → Last evaluated: 2 min ago · Next full scan: continuous

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
8
Active Vendors
5
On Track
2
KPI At Risk
1
Critical Issue
94%
Avg SLA Compliance

📊 Vendor KPI & Responsibility Matrix

Vendor Scope SLA Target Actual Status Key KPIs Escalation
PCG (CRO) Monitoring, Data Mgmt, Safety, TMF 95% 97% On Track Query resolution: 4.2d | Visit compliance: 98% | TMF: 96% ✅
Covance (Lab) Central lab, PK, biomarker 48h 52h At Risk Turnaround: 52h | PK: 72h | Integrity: 100% ⚠ L1
Interactive Clinical (IXRS) Randomisation, drug supply 99.9% 99.1% Critical Uptime: 99.1% (2 outages) | Support: 8.4h 🔥 L2
Medidata (ePRO) Patient diary, PRO capture 99.5% 99.8% On Track Uptime: 99.8% | Compliance: 94% | Helpdesk: 2.1h ✅
Almac (Supply) IP manufacturing, distribution 7d 5.8d On Track Accuracy: 100% | Temp: 0% excursion | Lead: 5.8d ✅
Quantics (Stats) Biostats, DMC, SAP Per MS On time On Track SAP: on time | DMC: on time | Queries: 3.2d ✅
Lexicon (Writing) CSR, CTR, reg writing 14d 16d At Risk Turnaround: 16d | Review: 1.8 rounds | Quality: 92% ⚠ L1
BioClinica (Safety) Safety DB, SAE, SUSAR 24h 18h On Track SAE: 18h | SUSAR: 100% on time | Recon: clean ✅

📨 Vendor Correspondence

🔥 IXRS Outage — RCA Requested Today 11:45 · Interactive Clinical

Second outage in 30 days (4.2h downtime). 3 sites unable to randomise. Vendor to respond by May 5.

Escalation ESC-2026-012 · Awaiting response
Covance Turnaround — Improvement Plan Accepted Apr 28 · Covance

52h avg vs 48h SLA. Root cause: staffing shortfall. 2 additional FTEs from May 12.

Performance PERF-2026-008 · Action plan accepted
Quantics — Interim Analysis Plan Approved Apr 25 · Quantics

DMC charter and interim analysis plan approved. First DMC look at 50% enrolment.

Milestone MS-2026-019 · Approved
Almac — Amendment 2 Supply Impact Confirmed Apr 22 · Almac

No impact on IP stock from new dosing schedule. Re-labelling: 10 business days. Cohort C expansion confirmed.

Protocol Impact PI-2026-004 · Confirmed

📋 Incident & Success Tracker

🔴 Open Incidents (3)

INC-024 — IXRS System Outage #2
Interactive Clinical · Apr 28 · Critical
4.2h downtime, 3 sites affected. RCA requested.
INC-023 — Covance Late Results Batch
Covance · Apr 22 · Medium
12 samples exceeded 48h SLA in single batch.
INC-022 — Lexicon Draft Quality Rejection
Lexicon · Apr 18 · Medium
Module 2.5 rejected. 2nd round of revisions required.

🟢 Recent Successes (5)

SUC-031 — PCG TMF Inspection Passed
PCG · Apr 29 · Achievement
Mock inspection zero critical findings. TMF 98% complete.
SUC-030 — Almac Zero Temp Excursions Q1
Almac · Apr 15 · KPI Exceeded
142 shipments, zero cold chain failures.
SUC-029 — BioClinica 100% SUSAR On-Time
BioClinica · Apr 10 · Regulatory
All 14 SUSARs within regulatory timelines.
SUC-028 — Medidata PRO Compliance >90%
Medidata · Apr 8 · Data Quality
Patient diary compliance at 94%, exceeding 90% target.
SUC-027 — Quantics SAP Delivered Early
Quantics · Apr 1 · Milestone
SAP delivered 5 days ahead of schedule.
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.

3
Active Systemic Risks
7
Process Reminders Set
12
Effectiveness Checks Done
94%
Recurrence Prevention

🚨 Systemic Risk Alerts

From CAPAs & PDs flagged as systemic
CRITICAL — CRC Data Entry Gaps (CAPA-003)

Root cause: Insufficient CRC training on EDC queries. 3 sites exceeded 15% query rate for 3 consecutive months. Now systemic — affects all future studies.

Systemic
🤖 AI Recommendation: Every CRC must follow this process before submitting data:
  1. Complete EDC field → run auto-validation check before saving
  2. If query flagged → resolve within 48 hours, log resolution reason
  3. Weekly: review own query rate on dashboard — flag if trending above 10%
  4. Monthly: attend DEOX CRC refresher (15 min) — completion tracked
HIGH — PK Sample Window Misses (DEV-002)

Pattern across Sites 101, 103, 105. PK samples collected outside ±2h window in 23% of visits. Indicates site-level process gap, not individual error.

Systemic
🤖 AI Recommendation: For every PK visit:
  1. 24h before visit: AI sends reminder to CRC with exact sample window times
  2. Day of visit: CRC confirms sample time slot booked in site calendar
  3. At collection: Log exact draw time — AI auto-checks if within window
  4. If miss detected: Immediate alert to PI + CRA, document reason, file deviation within 24h
MEDIUM — ISF Version Mismatches (Rule-006)

4 sites had outdated ISF documents detected during monitoring visits. Indicates onboarding document control process needs hardening.

Systemic
🤖 AI Recommendation: Document control process for every CRC:
  1. When new doc version issued → AI auto-notifies all affected sites
  2. CRC must confirm receipt and replace old version within 48h
  3. AI runs weekly ISF version audit across all sites
  4. Any mismatch → auto-flag to CRA for next monitoring visit priority check

📋 My Process Dashboard

📌 Today's Process Tasks

⏰ Upcoming Reminders

Tomorrow 8:30 PK Sample Window — Subject 105-012 V7, window 10:00-14:00. Confirm site ready.
Friday 9:00 Monthly CRC Refresher — 15-min DEOX EDC module. Attendance tracked.
Monday 10:00 ISF Version Audit — AI will run cross-site audit. Review findings by Tuesday.
Next Wed Effectiveness Check — CAPA-003: Query rate review (was 18% → target <10%)

🛡 My Bulletproof Processes

These are the processes the AI has coached you on. Follow every step, every time, and the issue never recurs.

EDC Data Entry (CAPA-003 Prevention)
Adopted 14 days ago ✅ 100% compliance
1⃣ Enter data → 2⃣ Run auto-validation → 3⃣ Resolve queries within 48h → 4⃣ Weekly self-check query rate → 5⃣ Monthly refresher
Effectiveness: Query rate dropped from 18% → 7% since adoption. No recurrence in 14 days.
PK Sample Collection (DEV-002 Prevention)
Adopted 3 days ago ⏳ 85% compliance
1⃣ 24h pre-reminder → 2⃣ Confirm time slot → 3⃣ Log exact draw time → 4⃣ AI auto-checks window → 5⃣ If miss: immediate alert + deviation within 24h
Effectiveness: PK window miss rate dropped from 23% → 8%. Still improving — next check in 4 days.
ISF Document Control (Rule-006 Prevention)
Adopted 1 day ago 🔄 Too early to measure
1⃣ Receive AI notification → 2⃣ Confirm receipt & replace old version within 48h → 3⃣ Weekly AI audit → 4⃣ Mismatch = auto-flag CRA
Effectiveness: First effectiveness check scheduled for next week. 1 ISF update processed correctly since adoption.

📊 Effectiveness Tracker

ProcessSourceBaselineCurrentTargetTrendStatusNext Check
EDC Query RateCAPA-00318%7%<10% ↓↓ Improving EffectiveMonthly
PK Window ComplianceDEV-00277%92%>95% ↑↑ Improving Monitoring4 days
ISF Version AccuracyRule-00680%—100% — No data yet NewNext week
🟢 All systems operational · API: 48ms avg · DB: 3ms avg · Uptime: 99.97%
· DEOX Clinical AI Platform v0.3.0 · ⌨ Shortcuts