RBQM

RBQM is Inductive Quotient's clinical oversight intelligence platform designed for clinical operations, medical monitoring, and data management teams. It provides a unified, near real-time view of study quality and performance by consolidating operational, quality, and risk signals — including enrollment, data quality, protocol compliance, safety, deviations, and site performance — into a single centralized environment.

The platform is aligned with the ICH E6(R2) RBQM framework and is designed to support evolving E6(R3) expectations. It enables teams to detect emerging risks earlier, monitor key risk indicators (KRIs) and quality tolerance limits (QTLs) continuously, and take timely action at both the study and portfolio levels.

Core Features

• KRI Monitoring: Tracks configurable key risk indicators continuously to identify emerging issues early.
• QTL Management: Monitors quality tolerance limits across critical study dimensions to support study control.
• Centralized Oversight Dashboards: Displays enrollment, data quality, safety, deviations, and operational trends in a single view.
• Site Intelligence and Benchmarking: Compares site performance across studies to identify outliers and underperforming sites.
• Risk Signal Detection: Detects trends, threshold breaches, and unusual patterns through real-time analytics.
• Risk Mitigation and CAPA: Manages actions, follow-ups, and remediation workflows in a structured environment.
• Cross-Functional Collaboration: Supports aligned review and decision-making across sponsor, CRO, clinical operations, medical monitoring, and data management teams.
• Portfolio-Level Visibility: Monitors risk and quality signals across studies, countries, and sites to support governance.

Key Risk Domains Monitored

The platform tracks more than 50 key risk indicators across four critical study domains:

• Enrollment: Enrollment rate vs. target, screen failure rate, randomization delays, and diversity and representation metrics.
• Data Quality: Query rate per page, aging queries over 14 days, missing data rate, and critical data field completeness.
• Protocol Compliance: Protocol deviation rate, important protocol deviation rate, visit window compliance, and informed consent timeliness.
• Safety: SAE reporting timeliness, AE coding completeness, uncoded events rate, and safety follow-up delays.

Platform Capabilities

• Unified environment connecting risk detection, monitoring, and action across study, site, and portfolio levels.
• Real-time dashboards and alerts that translate operational, quality, and compliance signals into actionable insights.
• Composite risk scoring and trend-based analytics to prioritize high-risk and underperforming sites.
• Built-in actions and CAPA workflows with structured ownership and follow-up tracking within the same platform.

Data Integrations

• EDC and CRF data
• RTSM and IRT systems
• Central laboratory data
• Safety systems
• ePRO and eCOA platforms
• CTMS and operational systems
• eTMF and document platforms
• Medical coding systems
• Wearable and sensor data
• Regulatory tracking systems
• Financial and budgeting systems
• Custom sources via APIs

RBQM connects data from across the clinical data ecosystem into a unified oversight layer, supporting more complete and timely visibility across the full scope of a clinical program.