Introduction to elluminate Risk-Based Quality Management (RBQM)
Presenter: Jonah BruggerRecorded Live: Thursday, October 28, 2021
As clinical trials continue to increase in volume and complexity, Risk-Based Quality Management (RBQM) – an approach supported by the FDA and ICH – can be leveraged to proactively manage risk throughout the trial lifecycle. elluminate® Risk-Based Quality Management provides clinical teams with a single platform that transforms numerous study data streams into actionable analytics and statistically significant insights. The result is a more focused and data-driven monitoring effort that enables active oversight and improves the quality and compliance of a clinical trial.
The elluminate RBQM offering has expanded and is now fully integrated with elluminate Data Central. This webinar will highlight why RBQM fits well within the elluminate clinical data cloud and will address the benefits of this offering for both new and existing clients. Additionally, we will discuss how clinical teams can maximize the value of their data with a platform approach and leverage elluminate RBQM to:
- Improve 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)
- Proactively monitor risk with well-defined QTLs and KRI tracking at the site and country level
- Resolve issues faster with automated issue management
- Easily explore data using pre-configured dashboards with drill-down capabilities
Who Should Attend
- Clinical Operations
- Medical Monitoring teams
- Central Monitoring teams
Jonah is a subject matter expert in conduct and management of clinical trials with industry experience in Life Science Information Systems, Clinical Trial Management, Life Sciences Data Warehousing, SDLC, AGILE Development, EDC, Life Science Regulatory Affairs, CDASH/CDISC, XML, PL/SQL, SQL, C#, Safety Reporting, TAP-based Technical Training, and Customer Software Enablement. Prior to joining eClinical Solutions as a Product Manager, Jonah spent 9 years with Oracle consulting on enterprise adoption in the life sciences.