Clinical Trial Risk and Performance Management Summit
7:30 a.m. – 8:30 a.m. |
Breakfast & MCC Demos |
The event starts the day with our two tracks, vendor oversight and risk-based quality management. Please choose the track that will help you the most. |
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VENDOR OVERSIGHT |
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8:30 a.m. – 9:30 a.m. |
OPENING SESSION
Liz Wool, President, Wool Consulting Group, LLC |
9:30 a.m. – 10:30 a.m. |
PANEL SESSION Utilizing Metrics to Manage Vendor Risk and Performance
Tom Littleton, Director, PPD Jacob Ehrlich, JD, MPH, Owner & Principal Consultant, Pure Health Consulting David Anderson, Manager, Process Excellence and Risk Management, Daiichi Sankyo Aaron Nolan, Consultant, Eli Lilly and Company |
10:30 a.m. – 11:00 a.m. |
Break |
11:00 a.m. – 12:00 p.m. |
SMALL GROUP EXERCISE Vendor Oversight Case Example (cont.)
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12:00 p.m. – 12:55 p.m. |
Lunch |
12:55 p.m. – 1:05 p.m. |
MCC Champions Award Presentation |
We are all back together for the group excercises. |
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1:05 p.m. – 2:30 p.m. |
INTERACTIVE SMALL GROUP EXERCISE Case Example — Follow the Process and Data Trail — Moving From Data Reports to Action Plans In this group exercise, participants will be separated into teams competing to uncover the root cause(s) of issues described in a case study. Each team will be provided with a case study packet that includes a description of the organization and outsourcing vendors, protocol synopsis, data reports, questions to explore and a worksheet to record the discussion. Teams may ask facilitators for additional information as the need arises. Exercise Wrap-up Teams will compare results, how they worked through the analysis and reflect on lessons learned. |
2:30 p.m. – 3:00 p.m. |
Summit Closing Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium |
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RISK-BASED QUALITY MANAGEMENT |
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8:30 a.m. – 8:50 a.m. |
OPENING SESSION
Keith Dorricott, Contractor for the Metrics Champion Consortium; Director, Dorricott Metrics & Process Improvement Limited |
8:50 a.m. – 9:30 a.m. |
PRESENTATION Risk-Based Quality Management/Centralized Monitoring — What Skills are Needed?
Nechama Katan, Associate Director, Central Monitoring, Pfizer |
9:30 a.m. – 10:30 a.m. |
PANEL SESSION The Future of Risk-Based Quality Management (RBQM) … What will it look like in 5 years?
Johann Proeve, Chief Scientific Officer, Cyntegrity Steve Young, Chief Operations Officer, CluePoints Olgica Klindworth, Director, PPD Nechama Katan, Associate Director, Central Monitoring, Pfizer |
10:30 a.m. – 11:00 a.m. |
Break |
11:00 a.m. – 12:00 p.m. |
BREAKOUT GROUP DISCUSSIONS Measuring Centralized Monitoring and Site Monitoring Keith Dorricott, Contractor for the Metrics Champion Consortium; Director, Dorricott Metrics & Process Improvement Limited What Skills are Needed by CRAs and Centralized Monitors with Risk-Based Site Monitoring? Sandra (SAM) Sather, MS, BSN, CCRA, CCRC Vice President, Clinical Pathways, LLC Applying Artificial Intelligence/Machine Learning to Risk-Based Quality Management Nechama Katan, Associate Director, Central Monitoring, Pfizer Coordinating the Roles of Sponsor and CRO in Risk-Based Quality Management Olgica Klindworth, Director, PPD Challenges of Gathering Information to Support Risk Evaluation Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium |
12:00 p.m. – 1:00 p.m. |
Lunch |
We are all back together for the group excercises. |
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1:00 p.m. – 2:30 p.m. |
INTERACTIVE SMALL GROUP EXERCISE Case Example — Follow the Process and Data Trail — Moving From Data Reports to Action Plans In this group exercise, participants will be separated into teams competing to uncover the root cause(s) of issues described in a case study. Each team will be provided with a case study packet that includes a description of the organization and outsourcing vendors, protocol synopsis, data reports, questions to explore and a worksheet to record the discussion. Teams may ask facilitators for additional information as the need arises. Exercise Wrap-up Teams will compare results, how they worked through the analysis and reflect on lessons learned. |
2:30 p.m. – 3:00 p.m. |
Summit Closing Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium |
WHO WILL BENEFIT
This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:
- Clinical Operations/Management/ Research/Development
- Clinical Outsourcing/Vendor Management/Third-Party Management
- Clinical/Project Operations
- Performance Analytics/Management/Reporting
- Metric Reporting/Visualization
- Quality Management/Clinical Quality Management
- Compliance/Clinical Compliance/ Regulatory Compliance
- Monitoring/Site Management/Study Management
- Clinical Risk Assessment
- Centralized Monitoring / Risk-based Monitoring
- Good Clinical Practices
- Clinical Process Optimization
- Vendor Oversight
The event is also of interest to:
- Central, Imaging and ECG Labs
- eCOA/ePRO companies
- eTMF companies
- CTMS companies
- EDC companies
- Data aggregation and visualization companies
- Other Clinical Service Providers