RBQM: What It Is. What It Isn’t. And Why IQRM Is the Next Step in Risk-Based Management

In response to growing trial complexity, regulators have spent the last decade+ making it clear that traditional, one-size-fits-all oversight models are no longer sufficient. RBQM, which helps sponsors focus on what truly matters to patient safety and data integrity, is now widely recognized as a regulatory expectation. Yet more than a decade after its introduction, RBQM adoption remains uneven, and implementation challenges abound.

While the principle behind RBQM was straightforward—identify what is critical, monitor those risks proactively, and allocate resources accordingly—the practice is quite complicated. Organizations can define their risk strategies, but execution often remains fragmented. Oversight still relies on siloed data, retrospective review, and function-specific decision making.

The result is not a failure of RBQM as a concept, but a gap in how it is executed.

Luckily, advances in technology, analytics, and regulatory guidance are enabling a more integrated, continuous model of risk-management. What we see emerging now, Integrated Quality Risk Management (IQRM), is not a replacement for RBQM but rather is an operational model that allows RBQM to function as intended: continuously, cross-functionally, and at scale.

In this blog, we explore what RBQM is, why it has been difficult to operationalize, and how IQRM represents the next step in effective quality oversight.

RBQM: A Brief History 

Over the past two decades, clinical trials have become increasingly global and complex, involving more sites, more stakeholders, and a growing number of data sources. Traditional oversight approaches—largely centered on exhaustive on-site monitoring and retrospective review—were not designed to scale with this level of complexity, nor were study designs built to manage ambiguous endpoints or excessive data collection. As studies expanded, unmitigated quality risks frequently escalated into operational issues, resulting in increased regulatory risks and trial delays. 

Regulators began to recognize this mismatch. Guidance such as ICH E6(R3), ICH E8 (R1), MHRA and other major regulatory agencies continue emphasizing a shift away from uniform oversight and toward an approach focused on identifying and managing risks to critical trial outcomes. This shift was not intended to reduce vigilance. Instead, RBQM was introduced to promote targeted vigilance: a more intentional, proactive approach to quality oversight designed to better align resources, risk, and trial complexity. 

Challenges Behind RBQM Adoption

Despite broad regulatory alignment, RBQM has not been universally adopted. Following the release of ICH E6(R3), concerns about inspections, audit findings, and trial outcomes meant that many sponsors held tight to their existing oversight models.  

Regulators took notice. In the years that followed, agencies such as the FDA and EMA issued additional guidance and public commentary, highlighting persistent gaps in implementation. It wasn’t until the COVID-19 pandemic disrupted traditional on-site monitoring, that many organizations began to fully realize the limitations of conservative approaches and the potential of more flexible models. 

Yet even as feasibility improved, some sponsors have remained hesitant to fully embrace risk-based practices.  

At its core, the barrier has not been philosophical alignment—it has been executional confidence. In high-stakes clinical trials, where patient safety and inspection readiness are on the line, teams often rely on conservative oversight when the operational infrastructure doesn’t fully support confident, defensible risk-based decisions. Without shared data, cross-functional visibility, and clear justification for why certain risks are prioritized over others, RBQM remains more of a planning exercise than an operational capability. 

Introducing IQRM, a More Integrated Approach to Managing Risk 

Clinical trial complexity and data volume now exceed what traditional, human-centered oversight models can reliably manage. This isn’t only an efficiency concern—it’s a quality risk: Signals are missed; root causes surface late; oversight becomes reactive rather than proactive. 

Recent regulatory guidance such as ICH E6(R3) reinforces expectations for continuous, integrated risk management. But guidance alone does not force operational change. Because sponsors are not compelled to shift their oversight models, the decision to evolve becomes a question of confidence. For many organizations, the issue is no longer whether risk-based oversight makes sense, but whether it can be executed in a way that is defensible and sustainable. 

IQRM addresses the execution gap that has limited RBQM’s impact. 

At its core, IQRM reframes quality risk management as a shared, continuous discipline. It’s characterized by: 

• Cross-functional ownership of risk: Risk is shared across clinical, operational, data, and quality teams rather than confined to monitoring alone. 
• Integrated, function-specific focus on critical risk: Risk signals are reviewed across data management, medical review, and monitoring functions to ensure each team prioritizes what is critical to quality and allocates resources accordingly. 
• Continuous risk identification and assessment: Risk is revisited and reassessed as studies evolve, rather than captured once in a static plan. 
• Proactive decision-making: Earlier awareness of risk supports timely action before issues escalate or impact trial outcomes. 

By shifting risk management from a reactive activity to an integrated way of working, IQRM enables sponsors to better anticipate challenges, align oversight with what matters most, and improve both trial quality and operational confidence. 

Why IQRM Is Becoming Possible Now 

Operationalizing IQRM requires the ability to: 

• Unite clinical, operational, and quality data from across systems.
• Apply advanced analytics to highlight meaningful patterns and emerging issues.
• Gain accessible and actionable insights so teams can assess risk and respond early.

Until recently, fragmented systems, siloed data, and limited analytical capabilities made it hard for teams to see and interpret the same information in time to act. But advances in data integration, analytics, and centralized review capabilities are beginning to change that.

Enabling IQRM in Clinical Trials

IQRM does not replace RBQM. It represents the outcome organizations are trying to achieve when RBQM is executed in an integrated, cross-functional way. 

But IQRM cannot be achieved through process alone. It requires a platform that unifies data, connects strategy to execution, and makes cross-functional decisions traceable and defensible. 

This is where the partnership between eClinical Solutions and ZS becomes meaningful: combining a centralized, RBQM-enabled data foundation with analytics and domain expertise to support IQRM in practice. 

elluminate RBQM, part of the elluminate Clinical Data Cloud®, supports proactive management of protocol and process risks at the study and portfolio levels. It provides a centralized, analytics-ready environment with configurable monitoring and workflows that support cross-functional oversight aligned to critical risk. By consolidating data review into a unified platform, organizations can make defensible decisions while improving efficiency and regulatory confidence. ZS brings life sciences consulting expertise to help organizations design lean process and adopt new ways of working. Their experience supporting large R&D organizations helps ensure risk-based approaches are applied consistently and effectively. 

Together, the partnership enables sponsors to operationalize IQRM by aligning data, analytics, and decision-making across a study’s lifecycle. 

Click here to learn more about eClinical Solution’s partnership with ZS.