Medidata RBQM

Drive the right quality at the right cost.

Medidata RBQM (Risk-Based Quality Management) is not a one-size-fits-all approach. Your main RBQM goals might be cost savings and improved efficiencies, or perhaps affordable quality and compliance. Any effort spent on quality above what’s needed is wasted. Any effort less than what’s required puts your trial at risk. The Medidata RBQM framework offers the right capabilities that life science companies need to execute a successful RBQM strategy. This framework provides a simple, easy-to-follow approach that highlights the best entry point for your organization.

Subject matter experts from Accenture, EMD Serono, and Medidata discuss how RBQM can help bring your drugs to market more efficiently.

The Medidata Rave RBQM Framework

Focus on critical data and processes by documenting risks, roles, and mitigation strategies.

With the Risk Assessment and Categorization Tool (RACT), you can capture components of a holistic Integrated Quality Risk Management Plan (IQRMP) through centralized documentation of the RACT, key risk indicators, source data review, and source data verification strategies. You don’t need risk assessment spreadsheets that are hard to track and manage. Because RACT is built on the Medidata Rave Clinical Cloud platform, it enables reuse of RACT information any time you need it, streamlining cross-functional collaboration and deployment of RBM strategies.

Identify and analyze known and unknown risks, anomalies, outliers, and patterns using machine learning.

Medidata Detect applies sophisticated machine-learning algorithms to analyze the clinical data in a trial for outliers, data anomalies, and trends. It quickly and accurately identifies risk areas, providing immediate insight into clinical trial performance and data quality. 

Optimize ROI with a site monitoring approach that allows you to redeploy resources to risk or problem areas.

The Medidata Rave Clinical Cloud platform enables Rave CTMS and Rave RBQM to share data elements with each other, facilitating a site monitoring approach that leverages resources efficiently by focusing on sites that have higher workload or monitoring needs. The reduction in redundant data entry saves a tremendous amount of time, both on-site and remotely. This unified functionality results in higher efficiency, increased productivity, and improved risk monitoring.

Improve your risk mitigation strategy and resolve issues faster.

With centralized, cross-functional issue management powered by the Medidata Rave Clinical Cloud platform, CRAs can optimize workload efficiencies by documenting issues appropriately and taking timely actions to ensure maximum collaboration across the clinical team.

Refocus CRA priorities with reduced source document verification.

With Rave TSDV, sponsors and CROs can focus on reducing SDV without sacrificing regulatory compliance or data quality strategies. Patients are assigned to pre-configured SDV regimens — focused on critical data — as they are enrolled, enabling study teams to achieve desired coverage levels.

A Day in the Life of a CRA

Related Solutions

Medidata Detect

Medidata Detect is a powerful data and risk surveillance tool for centralized monitoring, powered by automated statistical algorithms and machine learning, which improves study data quality and ensures patient safety throughout the trial.


Rave TSDV (Targeted SDV) identifies Rave EDC folders, forms, and data fields that will be selectively ‘targeted’ for SDV. It enables your CRAs to efficiently take action on critical to quality (CtQ) factors identified within risk management activities.


Rave CTMS is a unified digital solution that improves the speed, efficiency, and collaboration for the oversight of studies, countries, and sites through automation and workflow management. Rave CTMS supports activities including study/site team creation and activation, patient enrollment and milestone tracking, site monitoring, and issue management
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