Wednesday, 7th December, 2022
Establishing Key Risk Indicators and Setting Appropriate Thresholds: Getting the Most out of Your RBQM Solution
9:00am EST / 2:00pm GMT / 3:00pm CET
As clinical trials move towards a more data-driven approach with increased risk-based quality management (RBQM) adoption, study teams need in-depth understanding of key risk indicators and thresholds. Key risk indicators (KRIs) and thresholds are fundamental to an effective RBQM framework as they establish what risks will be monitored and create clear guidance when risks become actual issues. Without effective KRIs and reasonable thresholds in place, study teams can be left completing time-consuming data review only to find no issues. Careful and well-informed inputs into KRI creation and threshold setting make all the difference in being able to focus on the data that matters in your clinical trial. In this session, we will discuss strategies to consider when creating core KRIs, best-practices when setting thresholds, managing thresholds throughout the life of your study, and how to know if your thresholds are working for you.
Speakers:
Gayle Hamilton
Director, RBQM, Digital Trial Management Suite
IQVIA Technologies
Rachael Geedey
Associate Director, RBQM, Digital Trial Management Suite
IQVIA Technologies
View More Details +
Merck’s RBQM Approach: From Effective Implementation and Data Literacy to Solving Diversity Challenges in Clinical Trials
10:00am EST / 3:00pm GMT / 4:00pm CET
- Data literacy as the bedrock for risk based quality management approach
- Utilizing analytics to solve diversity in clinical trials
- Merck E2E RBQM modelling
Speakers:
Katherine Taylor
Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM
Merck
Krzysztof Zajdel
Risk and Analytics Lead (RAL), Risk Evaluation & Adaptive Integrated Monitoring (REAIM)
MSD
Lydia Matombo
System & Data Integration Lead (SDIL), Risk Evaluation and Adaptive Integrated Monitoring (REAIM)
MSD
View More Details +
Providing Insights as a Service to Enable a Risk-focussed Approach to Quality Management in Clinical Development
11:00am EST / 4:00pm GMT / 5:00pm CET
- Data Sciences and visualization technology enabling a close overview of the data flow in clinical development
- This enables Centralized Monitoring and Dynamic Site Monitoring
- A risk-focussed approach to Quality Management cannot be limited Site Monitoring
- Role of continuous improvement – moving from retrospective correction to prospective prevention
- Taking the next step & implementing the lessons learnt
Speaker:
Peter Stokman
Business Lead Clinical Data Reporting & Visualization Environment
Bayer
View More Details +