Central Monitoring & Risk-Based Quality Management

Smart RBQM Software for Clinical Trials

Central monitoring of KRIs and QTLs, a live Site Health Dashboard with CRA assignments and site-wise data review, and a risk workflow that runs from first signal to closed CAPA — with patient-level detail behind every flag, all in one platform built for sponsors, CROs and quality teams.

45%

Fewer Site Visits

3x

Faster Signal Detection

100%

Inspection-Ready

Central Monitoring Dashboard

Study Risk Overview

Live

Active Studies

18

Sites Monitored

214

Open Signals

27

Avg. Signal Resolution

4d

Risk Signals TodayNeeds Review

6 sites flagged for review this week.

CAPA Actions PendingAction Needed

11 corrective actions awaiting sign-off.

✨ Platform Modules

Five Modules, One Central Monitoring Platform

From the first risk indicator to the patient record behind it — RBQM Central Monitoring, Dashboard, Site Health Dashboard, Risk Workflow and Patient Profile work as one connected system.

🛰️
MODULE 01

RBQM Central Monitoring

The core engine behind the platform — continuous, centralized oversight instead of periodic site visits.

  • Central monitoring of KRIs and QTLs across every site and study, in one place
  • Centralized risk indicator dashboard pulling live data from EDC, safety and IRT systems
  • Statistical data monitoring with automated outlier and anomaly detection
  • Risk categorization mapped to each protocol's critical-to-quality factors
📊
MODULE 02

Dashboard

The portfolio-level view — every active study's risk posture, in one screen.

  • Cross-study, cross-site overview of open signals and risk trends
  • Configurable KRI/QTL widgets, charts and threshold breach alerts
  • Drill-down navigation from portfolio → study → site → subject
  • Live signal feed so nothing waits for a monthly report
🏥
MODULE 03

Site Health Dashboard

Know exactly which sites need attention, who owns them, and why.

  • CRA assignments — see which monitor owns which site at a glance
  • Site-wise data review status, so reviewers know exactly what's outstanding
  • Composite site health score combining quality, safety and operational signals
  • Site visit history, scheduling and performance trend over time
📝
MODULE 04

Risk Workflow

Every signal tracked from first detection through to a closed, documented action.

  • Automatic escalation from flagged signal to a logged issue
  • CAPA assignment with clear ownership, due dates and status
  • Configurable workflow stages and sign-off routing
  • Full, time-stamped audit trail for every risk decision
🧑‍⚕️
MODULE 05

Patient Profile

The subject-level detail behind every site-level signal.

  • Individual patient risk and safety flags, pulled into one profile
  • Visit completion and open query status per subject
  • Adverse event and protocol deviation history at the patient level
  • One click from a site-level signal down to the patient record behind it
🚀 Why Quality Teams Choose Us

Built For Defensible, Inspection-Ready Trials

We help sponsors and CROs reduce monitoring costs, catch risk earlier and keep a clean, audit-ready record across every study in the portfolio.

Catch Risk Before It's a Finding

Central monitoring of KRIs and QTLs surfaces emerging issues while there's still time to act, not after database lock.

Spend Less on Routine Monitoring

Risk-based, targeted site visits replace blanket 100% SDV, freeing monitoring budget for the sites that actually need it.

📈

Stay Ready for Inspection, Always

A complete, time-stamped record of risk decisions and CAPAs means there's nothing to reconstruct before an audit.

Portfolio Performance

Risk Health

On Track
Signals Resolved On Time88%
CAPA Closure Rate92%
On-Site SDV Reduction45%
Audit Readiness Score96%

18

Active Studies

214

Sites Monitored

4d

Avg. Resolution

🏢 Who It's For

Built For Every Clinical Research Role

One risk framework, shaped to how sponsors, CROs, monitors and quality teams each need to use it.

🏢

Sponsors & Clinical Ops

Get a real-time view of risk across every active study and site, without waiting on monthly monitoring reports.

Cross-Study ViewFaster Decisions
🧪

CROs & Multi-Study Programs

Standardize risk monitoring across sponsors and protocols, while keeping each program's thresholds and reporting separate.

Standardized SOPsMulti-Sponsor
📊

Data Management & Biostatistics

Surface statistical anomalies and data trends earlier, before they turn into database lock delays or queries.

Anomaly DetectionCleaner Data
🛡️

Monitors & CRAs

Work from a clear site assignment list, know what data still needs review, and act on the sites that actually need a visit.

CRA AssignmentsSite-Wise Review
⚙️ How It Works

From Protocol to Closed CAPA

A continuous loop that takes every risk signal from first detection to a documented, closed action — by design, not by chance.

📝
STEP 01

Define Risk

Set quality tolerance limits and key risk indicators against each protocol's critical-to-quality factors before the study starts.

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STEP 02

Monitor in Real Time

Central monitoring dashboards pull data from EDC, safety and IRT systems so every site's risk profile updates as data comes in.

🔎
STEP 03

Detect & Investigate

Signals are flagged automatically, with drill-down to the site, subject or data point driving the risk.

STEP 04

Resolve & Document

Assign CAPAs, track them to closure and keep a complete, audit-ready record of every decision made.

🔧 Problems We Solve

Common Risk & Quality Challenges We Eliminate

Pain points faced by clinical operations, monitoring and quality teams across sponsor and CRO organizations every day.

📉

Risk Signals Found Too Late

Without central monitoring, emerging risks often surface during a site visit or database lock — our dashboard flags signals the moment they cross a threshold.

📋

Manual SDV Driving Up Costs

Checking 100% of source data regardless of risk wastes monitoring budget — our risk-based targeting directs visits to the sites that actually need them.

🔀

Data Scattered Across Systems

EDC, safety and IRT data living in separate systems hides the full risk picture — our platform unifies every signal into one view per site and study.

🧑‍💼

No Clear Site Ownership

Without a single source of truth for who owns what, sites slip through the cracks — our Site Health Dashboard tracks CRA assignments and site-wise data review in one place.

📝

Findings Without Follow-Through

Issues get logged but CAPAs stall without an owner or due date — our risk workflow assigns, tracks and closes every action with a full audit trail.

🧑‍⚕️

Site Signals With No Patient Context

A site-level flag rarely tells the whole story — our Patient Profile module surfaces the subject-level detail behind every signal, instantly.

Ready to Modernize Your RBQM Process?

Get a free demo of our RBQM platform tailored to your studies. See central monitoring, the Site Health Dashboard, risk workflow and patient profile in action — zero commitment.