[June 29, 2026]

eClinical Solutions Advances Risk-Based Quality Management Solutions, Helping Sponsors Meet ICH E6(R3) Regulatory Guidelines

eClinical Solutions LLC, a global provider of digital clinical software and services, today announced enhanced risk-based quality management (RBQM) features within the elluminate^® Clinical Data Intelligence Platform. These advanced functionalities of elluminate RBQM, including access to improved administrative capabilities, cross-team collaboration functions, and workflow optimization, will improve processes across the clinical trial lifecycle, reduce fragmentation for sponsors, and ensure compliance with revised regulatory guidance.

RBQM has become entrenched with regulatory guidance over the past decade, with the most recent ICH E6(R3) guidelines providing a unified standard for designing, conducting, and reporting clinical trials. With a focus on continuous risk management, critical-to-quality factors, and proportionate oversight, the guidelines also enforce expectations on the use of digital tools, analytics, and diverse data sources to support decision making. Sponsors are already reporting an increased focus on risk-basedstrategies to ensure trial quality and regulatory compliance, according to eClinical Solutions' 2025 Industry Outlook, but less than one-third think their tech stack is effective at managing risk, making it critical to adopt a modern data infrastructure.

Historically, RBQM work streams-from reviews to alerts and observations-have been conducted outside of a centralized platform, with stakeholders unable to effectively collaborate without relying on multiple workflows and time-consuming and labor-intensive processes, ultimately increasing cost and time, even as cycle times remain the new currency of drug development. Now, these tasks can be completed directly within elluminate, where the platform's centralized workflows streamline cross-team collaboration, reduce fragmentation, and enable faster, more consistent execution of RBQM.

In the latest and immediately available updates to elluminate, users can expect:

• RACT Review and Approval Workflow: A review and approval workflow is available for configuration in Risk Assessments, allowing for improved collaboration among cross-functional team members with defined responsibilities for each assessment, feedback capture and iteration, and supporting the full review and approval document lifecycle as per GDocP. The enhancement consolidates the workflow within one platform, eliminating the historical challenge of silos, reducing manual work and time spent, building on the elluminate platform's IDRP capabilities.
• Site and Country Profile Insights: An intuitive way to provide a centralized view of site-and-country-level performance, KRI drivers, and timeliness of related actions, such as risk signals and issues, identifying underperforming sites and countries for additional actions, if needed.
• Collaboration with Non-Licensed Users via RBQM Alerts, Signals, and Issues: RBQM communications support assignment to and collaboration with non-licensed users-including CRAs, site monitors, and external partners-across alerts, risk signals, and issues. The enhancement supports alignment with ICH E6(R3) guidance by enabling cross-functional collaboration among stakeholders involved in risk management, even if the process is outsourced.

"As the industry continues to adapt to evolving regulatory frameworks and guidelines, including ICH E6(R3), sponsors and CROs require tools that are purpose-built to improve data quality and integrity while reducing the operational burden for sites and teams," said Nathan Johnson, Chief Product Officer at eClinical Solutions. "These enhancements are another step forward in advancing our vision for an intelligent, connected platform with a modern and scalable foundation, delivering meaningful innovation in quality risk management."

For more information about how organizations can employ effective, impactful RBQM strategies, view eClinical Solutions' Summer Webinar Series, "The Ins and Outs of RBQM": https://info.eclinicalsol.com/summer-series-rbqm

For more information about elluminate's latest upgrades and capabilities, and how eClinical is transforming modern clinical trial data infrastructure, you can visit: https://www.eclinicalsol.com/

About eClinical Solutions LLC
eClinical Solutions' industry-leading clinical data intelligence platform, elluminate®, and biometrics services experts help biopharma researchers at large, mid-size, and emerging life sciences organizations develop tomorrow's breakthroughs with today's resources. eClinical is a privately-held, purpose-driven company with a global workforce and winner of the 2025 Top Workplace USA Award: Remote Work, the 2025 Top Workplaces Culture Excellence Award: Work-Life Flexibility, and Great Place To Work® India Certification™. Learn more at https://www.eclinicalsol.com/ and follow eClinical Solutions on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260629776198/en/

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