I'm working in...
Arrow for button
Cross Arrow

I'm working in...


eClinical Solutions Enhances elluminate Clinical Data Cloud with RBQM

elluminate RBQM provides expanded capabilities to monitor risk across all trial data sources from a single platform

eClinical Solutions LLC, a global provider of cloud-based enterprise software and software-driven clinical data services that accelerate digital clinical initiatives, announced the inclusion of its Risk-Based Quality Management (RBQM) offering within the elluminate® Clinical Data Cloud. With this offering, clinical teams can transform numerous data streams into actionable analytics and statistically significant insights for a holistic, risk-based monitoring approach.

“As clinical trials continue to increase in volume and complexity, clinical teams can leverage RBQM to proactively identify potential issues from the moment they arise” says eClinical Solutions CEO Raj Indupuri.  “elluminate RBQM provides a renewed approach to risk-based quality management that enables active oversight and ensures study data integrity from start to finish.”

The elluminate RBQM offering is now fully integrated with elluminate Data Central, allowing clinical teams to maximize the value of all their data with a centralized, platform approach. Highlights from the elluminate RBQM offering include:

  • A holistic view of risk across all trial data sources with visualizations and interactive dashboards that show risk at the site and country level
  • The ability to define and track Quality Tolerance Limits (QTLs) within a study
  • Predictive modeling for KRI’s and QTL’s using both advanced statistical modeling and AI / ML frameworks
  • The Risk Assessment and Categorization Tool (RACT) provides a global library of risk assessment questions that can be tailored to a study’s protocol
  • Advanced data management workbench capabilities supporting data management, clinical operations, and data science functions

In addition to the expanded RBQM offering, new bidirectional integrations with Veeva Vault EDC and Oracle InForm provide additional interoperability for seamless data review. These expanded out of the box capabilities make it easier for trial sponsors to organize and review data across sources, simplify decentralized trials, and enable the use of analytics to identify data challenges. “The pandemic initiated a shift towards more modern approaches to clinical development including decentralized models and risk-based analyses” Indupuri continues. “RBQM is a key component to a more evolved approach, and combined with a clinical data cloud like elluminate, life sciences companies can enable operational efficiencies and ensure trial compliance from a single platform.”

About eClinical Solutions

eClinical Solutions helps life sciences organizations around the world accelerate their digital clinical initiatives. Our intelligent clinical data cloud and data services give our clients real-time, self-service access to all of their data from one centralized location; plus advanced analytics that promote smarter, faster business decisions. Find out more at www.eclinicalsol.com

2024 Industry Outlook: Driving Tomorrow’s Breakthroughs with Clinical Data Transformation