Mitigate Risk with a Platform Approach to RBQM

As innovation in clinical development continues to accelerate, decentralized trial models have become widely adopted across the industry. As a result, the volume and variety of clinical trial data continues to proliferate, adding to the complexity of clinical data management and monitoring practices. To ensure quality and compliance in modern trials, Risk-based Quality Management (RBQM) – an approach recommended by the FDA and ICH – can be leveraged to proactively manage risk throughout the trial lifecycle.

Part of the elluminate^® Clinical Data Cloud – the foundation of digital trials – elluminate RBQM provides clinical teams with a centralized location for all study data to support a more focused, data-driven monitoring effort that enables active oversight and improves trial compliance. With a holistic view of risk, potential issues are identified the moment they arise, ensuring study data quality and integrity.

This webinar will highlight the key benefits and features of elluminate RBQM for both new and existing clients. Additionally, we will discuss how clinical teams can leverage a platform approach to:

• Remove the need to access multiple applications for quality data, improving study oversight with a holistic view of risk across all data sources
• Streamline risk assessment using a comprehensive, global-standard risk assessment categorization tool (RACT)
• Differentiate areas of concern vs. non-significant changes in data with statistical significance using Centralized Statistical Monitoring Capabilities
• Proactively monitor risk with well-defined QTLs and KRIs; view and track risk factors at the site and country level
• Easily explore data using visualizations and pre-configured dashboards with drill-down capabilities

Who Should Attend

• Clinical Operations
• Medical Monitoring teams
• Central Monitoring teams

Presenter

Jason Konn

Solution Consultant, eClinical Solutions

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management. Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.