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What is Risk-Based Management and Monitoring (RBQM) software?

Risk-Based Management and Monitoring (RBQM) software is used to identify, assess, and manage risks in clinical trials. It helps teams focus monitoring efforts on the areas with the highest potential impact on patient safety and data quality. The software uses real-time data and predefined rules to flag issues early and guide corrective actions.

RBQM systems support centralized monitoring by collecting and analyzing site performance, data trends, and protocol deviations. The software helps prioritize monitoring visits, manage risk plans, and document actions taken. It reduces the need for routine site visits and supports a more targeted, efficient approach to trial oversight.

 

All Risk Based Management and Monitoring

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Maxis IT RBQM

Maxis IT RBQM

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 Read More...
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Cyntegrity RBQM

Cyntegrity RBQM

From study start-up to close out, the Cyntegrity RBQM Portal allows hands-on risk management across all data levels, complemented with ML-driven predictive analytics. With role-based access control, admins can control Read More...
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Qlarix RBQM

Qlarix RBQM

Partnering with CROs worldwide, WiseCLIN delivers innovative RBQM and oversight functionalities that align seamlessly with Sponsor expectations and regulatory requirements. Our intuitive tools and comprehensive training programs empower CRO teams Read More...
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metricstream logo 1

MetricStream Risk Management

Pharmaceutical, medical devices, and clinical research companies face an increasing amount of regulatory scrutiny and risks. Over the last few years, organizations have paid substantial fines for non-compliance. Regulators worldwide Read More...
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Cluepoints RBQM

Cluepoints RBQM

Leverage cutting-edge advancements in statistics and Machine Learning (ML) with AI-powered clinical trial solutions that go beyond traditional data analysis. By adhering to FDA and ICH guidelines and regulations, we Read More...
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Tri OPRA RBQM

Tri OPRA RBQM

OPRA-RAM transforms risk assessment and management by consolidating all activities into a single platform. Designed for ease of use, it allows teams to quickly prioritize risks, implement controls, and maintain Read More...
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Top benefits of RBQM software for clinical trials:

  • Early risk detection: The system flags data issues, delays, or safety concerns as they happen.
  • Smarter monitoring: Resources are focused on high-risk sites and processes.
  • Improved data quality: The software highlights trends and outliers for faster review.
  • Fewer on-site visits: Centralized tools reduce the need for frequent travel to research sites.
  • Real-time analytics: Dashboards and reports show current trial risks and site performance.
  • Regulatory compliance: RBQM features help meet industry standards for risk-based monitoring.
  • Clear documentation: All risk assessments and actions are logged in the system.
  • Flexible planning: Risk plans can be adjusted during the trial based on live data.

 

clinical trial software ecosystem, clinical trial software landscape

betterclinical showcases over 400 clinical trial software

-For an infographic of all these software solutions, have a look at the Clinical Trial Software Landscape.
-For further insight & resources on the Clinical Trial Software Industry, visit our Content Library.

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