Risk-Based Quality Management (RBQM)
A centralised monitoring and risk-based quality platform engineered for modern clinical trials. Shift from reactive, SDV-heavy oversight to proactive, risk-proportionate quality management -- identifying signals early, focusing resources where they matter most, and maintaining regulatory-grade documentation throughout.
Proactive Risk Management for Modern Trials
MTK's RBQM platform transforms clinical trial quality management from a retrospective, SDV-heavy exercise into a forward-looking, risk-proportionate discipline. By combining centralised statistical monitoring, automated Key Risk Indicator tracking, and configurable Quality Tolerance Limits, our platform surfaces emerging risks before they compromise patient safety or data integrity.
Whether you are managing a lean Phase I programme or overseeing a complex global Phase III trial with hundreds of investigator sites, MTK RBQM adapts to your protocol's risk profile. Define thresholds at the study, country, or site level, receive automated alerts when patterns deviate from expected norms, and generate audit-ready risk reports that satisfy ICH E6(R2), ICH E6(R3), and FDA expectations for risk-based oversight.
Comprehensive Risk-Based Quality Oversight
Our RBQM platform delivers a full spectrum of risk management capabilities -- from initial risk assessment and KRI configuration through centralised monitoring, CAPA management, and adaptive monitoring strategy optimisation.
Key Risk Indicators (KRIs)
Monitor trial health in real time with a configurable KRI library that tracks site performance, data quality, and operational metrics against predefined thresholds.
- Configurable KRI library with 50+ templates
- Automated threshold monitoring & alerting
- Longitudinal trend analysis per site
- Site-level composite risk scoring
Quality Tolerance Limits (QTLs)
Define statistical boundaries for critical quality parameters and receive immediate notification when observed values breach acceptable ranges at any level of the study.
- Statistical QTL definition & calibration
- Automated breach detection & notification
- Tiered escalation workflows
- Regulatory-ready documentation & reporting
Centralised Statistical Monitoring
Detect anomalous data patterns across sites using advanced statistical methods that identify outliers, fabrication signals, and systemic quality concerns.
- Cross-site data pattern analysis
- Statistical signal detection algorithms
- Outlier identification & flagging
- Data fabrication & misconduct detection
Risk Assessment & Planning
Identify, categorise, and plan mitigation strategies for protocol-level risks before the first patient is enrolled using structured assessment frameworks.
- RACT (Risk Assessment Categorisation Tool)
- Protocol-level risk identification
- Mitigation strategy planning & tracking
- Living risk register management
CAPA Management
Track corrective and preventive actions from identification through verification with structured workflows that ensure every quality issue reaches full resolution.
- Corrective & preventive action tracking
- Root cause analysis workflows
- Effectiveness verification & sign-off
- Audit-ready CAPA logs & history
Monitoring Strategy Optimisation
Dynamically adjust monitoring intensity based on real-time risk signals, reducing unnecessary on-site visits while directing attention to sites that need it most.
- Adaptive monitoring frequency adjustments
- Site risk-based visit scheduling
- Reduced on-site monitoring burden
- Resource allocation dashboards
Connected Quality Across the Trial
MTK RBQM does not operate in isolation -- it draws data from and feeds insights back into every module in the eClinical suite. Real-time data flows ensure that risk signals detected in centralised monitoring automatically inform monitoring visit plans, remote verification priorities, and executive-level risk dashboards.
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EDC Integration
Real-time clinical data feeds power centralised monitoring analytics, enabling KRI calculations and statistical signal detection as data is captured.
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CTMS Integration
Risk scores and KRI trends drive monitoring visit scheduling, automatically adjusting site visit frequency based on current risk profiles.
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rSDV Integration
Risk signals direct targeted remote source data verification efforts, focusing reviewer attention on high-risk data points and flagged sites.
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Analytics Integration
Unified risk dashboards combine RBQM signals with operational and clinical data for predictive analytics and executive-level quality reporting.
Why Choose MTK for RBQM
Effective risk-based quality management requires more than dashboards and alerts. It demands a platform grounded in regulatory science, integrated with your trial operations, and built to scale from single-site studies to global programmes.
Regulatory Alignment
Purpose-built to satisfy ICH E6(R2) and ICH E6(R3) requirements for risk-based approaches to clinical trial quality, with FDA guidance alignment built in.
Unified Platform
RBQM is natively integrated with EDC, CTMS, rSDV, and Analytics -- sharing one data layer so risk signals flow seamlessly across your entire trial operation.
Proven Methodology
Our RBQM framework is grounded in established statistical methods and industry best practices, refined through real-world application across therapeutic areas and phases.
Scalable Architecture
From a focused Phase I study with a handful of sites to a global Phase III programme spanning hundreds of centres, our platform scales without compromising performance.
See RBQM in Action
Schedule a personalised demonstration to discover how MTK's RBQM platform can transform your clinical trial quality oversight with centralised monitoring, automated risk detection, and regulatory-aligned quality management workflows.