The Future of RBQM: Insights From Everest Group’s 2025 Tech Provider Spotlight 

Over the past decade, Risk-Based Quality Management (RBQM) has become firmly embedded in regulatory guidance and sponsor strategy. Yet as clinical trials grow more complex, the demands placed on RBQM have changed. So has the conversation: It is no longer centered on whether to adopt risk-based approaches, but on how to execute them at scale.

Everest Group’s 2025 Tech Provider Spotlight: Risk-Based Quality Management (RBQM) outlines several trends shaping the RBQM landscape, including the integration of AI and predictive analytics, the digitization of oversight, regulatory acceleration, and the convergence of RBQM with clinical data management. Together, these themes point to an industry focus that is expanding beyond traditional monitoring activities toward more integrated, data-driven approaches to risk oversight. 

Below, we explore highlights from the Everest Group Tech Provider Spotlight and what they may mean for your organization. 

Key Trends and Challenges Shaping the RBQM Landscape

The 2025 Tech Provider Spotlight: Risk-Based Quality Management (RBQM) report identified several trends influencing how sponsors approach risk oversight today: 

• Integration of AI and predictive analytics 
• Regulatory acceleration of risk-based oversight 
• Digitization of clinical trial oversight 
• Convergence of RBQM and clinical data management

Meanwhile, some of the key challenges to quality found in clinical trials included reactive and rigid monitoring practices, high site burden (like excessive documentation and complex protocols), lack of real-time data oversight, patient safety oversight delays. 

What does this mean for sponsors?  

As AI-driven analytics, digitized oversight, and regulatory expectations increase, risk signals depend on timely, harmonized data across systems. Sponsors evaluating RBQM strategies may want to consider how effectively their current approaches support integration across risk assessment, centralized monitoring, and mitigation workflows. 

Considerations When Selecting RBQM Products

In outlining the evolution of RBQM, the Tech Provider Spotlight determined that RBQM was “progressing toward a technology-enabled, adaptive model” that ingrates AI, real-time analytics, and an interoperable platform.  

In laying out important considerations for selecting RBQM platforms, the Tech Provider Spotlight highlighted the importance of:  

• Technology fit and integration 
• Collaboration, compliance, and security 
• Early planning and change management,  
• Continuous review and improvement.
• Awareness, knowledge, and skillset.  

What does this means for sponsors?   

Effective RBQM programs require effective technology as well as an effective implementation strategy. When selecting a platform, it’s important to not only consider functionality like RACT, KRIs, QTLs, and issue tracking, but to also consider the collaboration that platform enables. This includes collaboration with other systems (IE integration), as well as cross-functional collaboration across teams.  

Explore the Tech Provider Spotlight: Risk-Based Quality Management (RBQM) Report 

Download our licensed version of the Everest Group Tech Provider Spotlight: Risk-Based Quality Management (RBQM) to discover the key trends shaping the RBQM market and explore an analyst perspective on the evolving RBQM landscape. 

You’ll also see how elluminate RBQM—part of the elluminate Clinical Data Cloud®—includes: 

• A configurable Risk Assessment and Categorization Tool (RACT) 
• Structured risk libraries and AI-assisted risk statement generation 
• Oversight of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) 
• Data Central dashboards supporting centralized monitoring 
• Role-based workflow engine and issue management integration creates a seamless workflow across teams 

An evolving roadmap extending AI/ML into anomaly detection and predictive oversight