Smart RBQM Software for Clinical Trials

Central monitoring of KRIs and QTLs, a live Site Health Dashboard with site-wise data review, and a risk management workflow from initial signal detection to resolution — 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

Clinical Trial Risk Monitoring

Quality and risk at a glance

Live

Active Studies

12studies

Currently in progress

Open High Risks

8risks

High-priority risks

Open Risk Signals

15signals

Requiring review

Protocol Deviations

23deviations

Pending resolution

Data Quality Issues

31issues

Outstanding issues

Overdue Monitoring

6activities

Past their due dates

Risk Monitoring Trends

Illustrative weekly activity

SignalsDeviationsData issues
W1W2W3W4W5W6

Unified study oversight

Risk-based monitoring
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
  • A centralized risk indicator dashboard that integrates 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

A portfolio-level view of every active study's risk profile, all on 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 at a glance which monitor is responsible for each site
  • Site-level 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 trends over time
MODULE 04

Risk Workflow

Every signal is tracked from initial detection through to a documented resolution.

  • 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 consolidated into a single profile
  • Visit completion and open query status per subject
  • Adverse event and protocol deviation history at the patient level
  • Navigate from a site-level signal to the corresponding patient record in one click
Why Quality Teams Choose Us

Built For Defensible, Inspection-Ready Trials

We help sponsors, CROs, and quality teams manage clinical studies, assess risks, monitor KRIs and QTLs, oversee sites and subjects, and maintain secure, role-based access — all in one platform.

Study Management

Manage clinical studies in one place with centralized study-level information and progress visibility.

Risk-Based Analysis

Identify potential risks early and support data-driven decisions through continuous risk assessment.

KRI/QTL Monitoring

Monitor Key Risk Indicators and Quality Tolerance Limits to identify deviations and emerging trends.

Site Management

View site-level information and track site status and performance across clinical studies.

Portfolio Performance

Risk Health

On Track
Study ManagementStudies
KRI/QTL MonitoringRisk Indicators
Site ManagementSite Overview
Role-Based Access ControlPermissions

Studies

Study Management

Sites

Site Management

Subjects

Subject Management

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 risks across all active studies and sites without waiting for 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 lead to database lock delays or additional queries.

Anomaly DetectionCleaner Data

Monitors & CRAs

Work from a clear site assignment list, identify data that still needs review, and prioritize sites that require a visit.

CRA AssignmentsSite-Wise Review
How It Works

From Protocol to Closed CAPA

A continuous process that takes every risk signal from initial detection to a documented resolution — 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.

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

Risk in Traditional Clinical Study Management

Simplify clinical study oversight with centralized study management, risk-based analysis, KRI/QTL monitoring, site and subject management, and secure role-based access control.

Study Information Across Multiple Places

Managing study details separately makes oversight difficult. Study Management brings key study information together in one centralized view.

Risks Difficult to Identify Early

Potential risks can go unnoticed without structured analysis. Risk-Based Analysis helps teams identify risk patterns and prioritize areas that need attention.

Limited KRI/QTL Visibility

Tracking Key Risk Indicators and Quality Tolerance Limits manually can make emerging trends harder to spot. Centralized KRI/QTL monitoring helps teams review indicators and identify deviations.

Limited Site-Level Oversight

Keeping track of multiple clinical sites can be challenging. Site Management provides an organized view of site information and supports study-level oversight.

Subject Information Is Hard to Track

Disorganized subject-level information can make study oversight more difficult. Subject Management helps teams access and review relevant subject information in one place.

Role-Based Access Control

Giving every user the same level of access can expose information unnecessarily. Role-Based Access Control helps manage permissions according to assigned user roles.

FAQs

Risk-Based Quality Management (RBQM) is an approach to clinical trial oversight that identifies, assesses, and monitors risks that could affect participant safety or the reliability of trial data. It helps sponsors and CROs prioritize critical areas throughout a study.
RBQM software helps clinical research teams centralize study oversight, monitor Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), identify potential issues, and track corrective actions to support informed decisions.
Key Risk Indicators (KRIs) help teams identify and monitor potential risks during a clinical trial. Quality Tolerance Limits (QTLs) define acceptable ranges for critical study-level quality measures and help teams identify significant deviations that may require investigation.
Central monitoring enables teams to review study and site data remotely, identify unusual trends, prioritize sites that need attention, and investigate potential risks without relying exclusively on routine on-site monitoring visits.
Sponsors, Contract Research Organizations (CROs), clinical operations teams, data management professionals, biostatisticians, and Clinical Research Associates (CRAs) can use RBQM software to support risk oversight and clinical study management.
RBQM software can help teams review risk signals, investigate issues, assign corrective and preventive actions (CAPAs), monitor resolution progress, and maintain records of decisions and actions throughout a clinical study.

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.