Risk-Based Quality Management (RBQM)

Monitor and mitigate risks with an integrated RBQM solution

Improve trial performance with a dedicated risk-based monitoring tool

Accelerate trial performance and assure compliance by taking a risk-based monitoring approach to clinical trial management.

MaxisIT’s dedicated risk-based quality management (RBQM) solution works with our entire product suite to de-risk trial operations and management.

Integrated Risk Management 

Seamlessly integrate and customize your study for real-time insights and better decision-making.


Improved Data Integrity

Comprehensive risk management empowers users to evaluate data and processes throughout the trial, allowing monitoring across diverse study formats.

Enhanced Decision-Making

Predictive risk assessments and recommendations enable better decision-making to improve patient safety, protocol compliance, trial oversight, and site performance.

Streamlined Trial Operations

AI-powered tools provide insights into patient outcomes and trial trends, enabling data-driven adjustments and improving overall trial performance.

Adaptive Trial Management

The system's flexibility allows for adjustments to trial parameters based on real-time data, optimizing outcomes.

Efficient Collaboration

Role-based dashboards and integrated workflows enhance teamwork, ensuring all stakeholders have access to relevant data.


Ready to see RBQM in action?


Risk-Based Quality Management Overview

Save weeks to months off study execution with a scalable data management solution.

Integrated Workflows

Access a unified platform for monitoring and mitigating risks, utilizing the Risk
Assessment & Categorization Tool (RACT) and the Integrated Quality and Risk
Management Plan (IQRMP).

Risk-Based Data Review

Monitor risks using customizable key risk indicators (KRIs) to quantify and track potential risks throughout the study. Employ quality tolerance limits (QTLs) to establish thresholds for acceptable quality levels, ensuring data integrity and compliance with regulatory standards.

Fully Configurable

Experience flexibility with a solution that is completely configurable, interoperable, and scalable, tailored to meet the specific study requirements of your team.

Self-Service Setup

Launch your studies quickly using a modular framework that is user-friendly and requires no programming skills.

Visualized Insights

Customize and secure study data with role-based dashboards and out-of-the-box data visualizations, empowering stakeholders to tailor insights to their specific needs.

Automated Real-time Results

Leverage AI to continuously monitor data patterns, identify outliers, anomalies, and critical risks in real-time. Use Natural Language Processing (NLP) tools for comprehensive analysis of structured and unstructured data, enhancing the depth and accuracy of insights.


  • Sergey Krymgold, Senior Director of Clinical Trials, Tools, and Technologies at Takeda Pharmaceuticals
  • Aarti Sanadi, Associate Director of Clinical Trials, Tools, and Technologies at Takeda Pharmaceuticals
  • Data Analytics Innovations: Insights from Jayasree Ivaturi, Associate Director at MaxisIT
  • Randall Paulk, Senior Manager of Data Management Clinical Systems at J&J Vision Care
  • Greeshma Mundayat, Clinical Solutions Owner at MaxisIT

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