A Modern Approach to Risk Management
Clinical development has evolved significantly in recent years, bringing both opportunities and challenges to how clinical trials are managed. With an average of 3 million data points, and 10+ data sources per study, sponsors must implement a risk-based approach in order to ensure patient safety and comply with ICH mandates and regulatory guidance. Recognizing that a new approach to risk-management requires changes to be made within organizations, it benefits sponsors to understand the drivers and scope of these changes in order to strategically and optimally implement RBQM. Because taking a risk-based approach will involve new processes and technology, sponsors should consider selecting an RBQM solution that enables desired outcomes to be achieved in the least complex way.
This webinar will address how to strategically approach RBQM implementation at your organization to optimize resources and increase efficiencies. We will discuss the benefits of elluminate RBQM and highlight the advantages of leveraging an RBQM solution that is integrated with a clinical data platform.
What You Will Learn
- RBQM: What it is and how to approach it
- Key points to consider when assessing RBQM solutions to ensure desired outcomes are achieved
- How leveraging an RBQM solution integrated with a clinical data platform enables a more comprehensive approach to risk management
Who Should Attend?
- Data Management
- Clinical Operations
- Central Monitoring
- Medical Monitoring
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.