Risk-Based Quality Management (RBQM) is fast becoming a staple in clinical research, and the community is still learning new ways in which the approach can add value to drug development and Sponsor organizations.
From monitoring sustainability metrics to enabling proactive inspection readiness, the model—first mandated by the International Council for Harmonization (ICH) in its guideline for good clinical practice, E6(R2), in 2019—has laid the foundation for risk-based approaches across the industry. With the advent of E6(R3), which builds on R2 by emphasizing flexibility, critical thinking, and a more holistic, quality-by-design approach, the model now has even more to offer. And as we’ll explore later, tools like CluePoints’ Site Profile & Oversight Tool (SPOT) are taking that value even further, turning insight into action.
During an RBQMLive session, Dan Beaudry, CluePoints’ Senior Vice President of Customer Success, sat down with leading experts to explore their real-world experiences, key lessons, and the impact of RBQM in driving data integrity, operational efficiency, and regulatory confidence.
Risk-Based Quality Management (RBQM)’s Evolving Utility
As RBQM takes center stage in clinical research, sponsors are uncovering a growing list of benefits—some anticipated, others surprising. That was the consensus shared by Amit Gulwadi, Vice President and Head of Transformation at Alexion; Blake Jensen, Quality and Compliance Executive at Adagio; and Jessica Jackson, Head of Clinical Operations at Galderma, during a recent discussion.
Jackson explained that Galderma’s initial motivation for adopting RBQM was to increase efficiency and reduce costs—critical priorities in a landscape where sponsors are expected to do more with less.
“When I first came into the industry, we were asked to read 100% of the data,” she explained. “RBQM has allowed Galderma to read more with fewer site visits. As a result, it drives trial efficiency and lowers overall costs without compromising safety.”
Historically, clinical trial monitoring relied on exhaustive approaches like 100% source data verification (SDV), where every data point collected at a site had to be reviewed manually. This method was time-consuming, resource-intensive, and expensive, requiring frequent site visits by Clinical Research Associates (CRAs). It also often failed to distinguish between high-risk and low-risk data, leading to inefficient use of monitoring resources.
RBQM became the modern, data-driven alternative. Mandated by ICH E6(R3) and supported by regulatory agencies like the FDA and EMA, RBQM enables centralized, risk-based oversight of trial data. Tools such as statistical monitoring, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs) help identify where the real issues are likely to occur, so teams can focus their attention accordingly.
- Increased Monitoring Precision: With RBQM, organizations don’t have to review all data blindly. Instead, the focus is on critical-to-quality data points and outliers.
- Improved Efficiency: Centralized monitoring combined with targeted risk indicators streamlines workflows, allowing teams to manage more sites and data with the same or fewer resources.
- Cost Reduction Without Compromise: Perhaps most importantly, RBQM helps lower operational costs without sacrificing patient safety or data integrity. This is a crucial balance in today’s climate of rising trial complexity and constrained budgets.
The benefits have not stopped there, Gulwadi told the virtual audience. “One of the key things we have been tracking is our commitment to sustainability—specifically, the reduced carbon emissions because of fewer site visits. I would not have even thought about that a year ago.”
This insight reflects a broader shift in how life sciences organizations evaluate the impact of their operations. Traditional monitoring practices often involve significant travel by CRAs, contributing to greenhouse gas emissions and bloated operational footprints. By replacing many of these in-person visits with centralized, data-driven oversight, RBQM offers a tangible opportunity to reduce the environmental impact of clinical trials.
Site Inspection Readiness
One of the most critical and sometimes overlooked advantages of risk-based approaches is their ability to support proactive site inspection readiness, said Blake Jensen, Quality and Compliance Executive at Adagio.
“This is changing the way we do clinical operations and monitoring. For example, using risk-based approaches in a Quality Assurance (QA) role was not something I had anticipated before,” he said.
For smaller biotech companies, he added, the stakes are especially high. With only a few compounds in development, success often hinges on the quality and completeness of regulatory submissions. And while traditional methods like manual SDV have their place, they’re simply not enough to catch every issue. Risk-based methodologies offer a smarter, more strategic layer of oversight that can make the difference between approval and delay.
“As a QA person looking at audits and reviewing monitoring reports, there are connections and risks that we will always be blind to. Even medical directors who oversee the depths of the trial will not be able to see some of these things,” said Jensen. “When we plug all of the data into the CluePoints tool, we can see all the potential risks that might be under the surface.”
This level of insight doesn’t just support operational decision-making; it strengthens inspection readiness across the board. By surfacing early signals and anomalies, RBQM enables informed, cross-functional conversations between QA, clinical operations, and development teams.
“If an inspector says ‘this looks funny,’ you can explain that you have already had those discussions, and you can provide the answers,” said Jensen, adding that this kind of proactive management provided a “comfort level” that was unobtainable with traditional means. “It gives us that reassurance that if we make this submission, it will not tank the company.”
Building on this theme, Jackson said that risk-based approaches provided companies like hers, which outsources much of its research to CROs, the opportunity to intervene in a timely manner. “There are certain aspects of a trial that we feel confident outsourcing, but we own safety and oversight,” she said, adding that RBQM generated real-time signals that prompt immediate action.
She shared a recent example: one site rapidly enrolled 17 patients during a resource-constrained period and reported no adverse events over eight months.
“Because we were running the CluePoints solution, we could see the alerts. That allowed Galderma to step in and take action immediately. We were proactive and could easily document our reviews for an inspector should they ask about this particular site.”
In today’s regulatory environment, where preparedness and transparency are non-negotiable, RBQM is emerging as a critical enabler of confident, inspection-ready trial execution.
Acquisition Evaluation
Gulwadi also shared how Alexion leverages CluePoints’ advanced analytics to streamline and strengthen the acquisition process.
“When you acquire companies and assets, you don’t know what you are getting,” he said. Traditionally, evaluating that data has been a manual, time-consuming process that frequently misses critical signals.
“The beauty of the algorithms is that they can surface data trends and discrepancies that provide markers on where to focus deeper dives. That has helped us to understand the risks we are inheriting and that data management, or DevOps, needs to absorb much faster,” he explained.
As RBQM technology matures, unconventional applications like this are becoming more common, the panel agreed, expanding its role beyond traditional trial oversight into broader strategic operations like M&A. To explore this discussion in more depth, access the on-demand recording of this RBQMLive.
Site Profile & Oversight Tool (SPOT): The Logical Next Step
If RBQM gives Sponsors the ability to see where risks lie, CluePoints’ Site Profile & Oversight Tool (SPOT) gives them the means to act on those insights—precisely, efficiently, and in real time.
SPOT represents a natural extension of CluePoints’ leadership in RBQM. It enables adaptive site monitoring by integrating key indicators—such as central data review signals, workload estimates, and operational triggers—into a single, interactive view of trial site performance. Instead of relying on fixed schedules or subjective judgments, Sponsors and CROs can now prioritize visits based on actual risk and need, optimizing resources while maintaining tight oversight. Whether reallocating site visits, identifying centers that require additional support, or flagging potential compliance issues, SPOT empowers teams to make more informed decisions faster.
SPOT also plays a critical role in inspection readiness and documentation. Every risk signal, site activity, and action taken is fully auditable, creating a transparent, traceable record that can be shared confidently with regulators. This is especially valuable for Sponsors managing multiple outsourced functions, where centralized oversight is essential for ensuring accountability. Get a more detailed overview of SPOT in CluePoints’ comprehensive guide to adaptive site monitoring.
