Clinical Trial Risk and Performance Management Summit

Day2

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.

VENDOR OVERSIGHT

8:30 a.m. – 9:30 a.m.

OPENING SESSION

  • Re-cap day 1
  • Risk-based vendor management overview: critical vendors for successful clinical programs
  • Vendor oversight — the need to understand the work being performed to effectively manage and measure performance
  • What are the foundational metrics that can be applied for all vendors?

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

  • Critical vendors, inherent risks and approaches to manage the risks and the utilization of metrics for performance management and clinical trial integrity
  • Contract research organization (CRO) metrics — what metrics will give you a good idea of their risks, performance and clinical trial health?
  • Vendor metrics — designing metrics for all stakeholders — functional department, study teams and quality/compliance

Tom Littleton, Director, PPD

Jacob Ehrlich, JD, MPH, Owner & Principal Consultant, Pure Health Consulting

David Anderson, Manager, Process Excellence and Risk Management, Daiichi Sankyo

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.)

  • Use your table information and results from the day 1 activity
  • Identify metrics for each of these categories:
    • Timeliness
    • Cycle time
    • Quality
    • Relationship

12:00 p.m. – 1:00 p.m.

Lunch

We are all back together for the group excercises.

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

 

RISK-BASED QUALITY MANAGEMENT

8:30 a.m. – 8:50 a.m.

OPENING SESSION

  • Recap day 1
  • Introduction to critical thinking skills

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?

  • Learnings from implementation of risk-based site monitoring
  • Importance of team participation for critical thinking

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?

  • Implementation of RBQM in virtual trials
  • Risk-based study execution (RBx): Beyond risk-based monitoring
  • Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO): High volume, non-case report form (CRF) data and RBQM
  • What’s the role of artificial intelligence and machine learning in RBQM?

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.

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

 

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