Measuring Success of a Quality Risk Management Approach
Sponsored by: Covance
- Clinical Trials
- Risk Based Quality Management
Date: 4 February
Time: 4PM London/11AM New York
Evaluating efficiency and quality metrics for clinical trials
As regulatory guidance and data collection in clinical trials has evolved, sponsors face pressure to balance quality, productivity and cost for risk management and monitoring. The industry has adopted risk based quality management (RBQM), yet the methodology is inconsistent. There is no standard way to measure the impact of the different approaches to RBQM on the effectiveness of clinical trial management.
How can the industry define the benefits of RBQM and develop standard benchmarks? Join our educational webinar to get insights on establishing and tracking metrics to measure the success of RBQM. We will discuss metrics related to specific processes and technology, and cover key considerations for establishing internal metrics as well as those that could apply across the industry.
Register now to learn more about our approach on how to define the impact of RBQM, efficiency and quality metrics, and the challenges associated with selecting meaningful measures.
Kristin Stallcup, MS, PMP,
Senior Director, Xcellerate Customer Success, Covance Inc.
Kristin Stallcup brings 15 years of experience in various trial management capacities to her current role as senior director responsible for implementation and business process adoption of the Covance XcellerateÂ® Informatics suite. She previously led the development and implementation of Xcellerate Risk and Issue Management, providing clients with Xcellerate Monitoring methodology and technology implementation. Kristin holds an MSHS in clinical research management from George Washington University, a BS in molecular biology from Vanderbilt University and Project Management Professional (PMP) certification.
Senior Manager, Informatics
Daniel Kowalski has 13 years of professional experience within the industry in the biometrics area, from SAS Programming through Biostatistics and Data Management to Informatics. In his role within Covance Informatics department Daniel was responsible for development and implementation of Xcellerate Data Review Suite. Currently he leads XMICS team responsible for the setup of Xcellerate tools, focuses on expanding the use of Xcellerate as well as co-leads several enhancements projects.
Daniel holds MSc degree in the field of Pure Mathematics from Jagiellonian University in Cracow, Poland.
Key Learning Objectives
- Understand the challenges faced in adopting risk-based quality management practices
- Get insights on how to define and track risk-based management at an organizational level
- Hear about meaningful comparators that can be used across trials or a therapeutic area
- Gain knowledge on defining efficiency and quality metrics in your technologies and processes
- C-Level in Clinical Trials Management
- Information Technology
- Information System Management
- R&D Management
- Quality Management
- Operations Management