Clinical Trial Risk and Performance Management Summit

Day1

7:30 a.m. – 8:45 a.m.

Breakfast

8:45 a.m. – 9:00 a.m.

Welcome Session

Linda Sullivan, Co-Founder & Executive Director, Metrics Champion Consortium

9:00 a.m. – 10:00 a.m.

Secrets to Implementing Successful Metric Programs
(Part 1)

  • Deciding what to measure – tools and metric maturity model (metrics, systems, people, process)
  • Establishing data requirements
  • Aggregating reliable data in a timely manner – make or buy?
  • Designing metric reports that are easy to understand and provide context
  • Using metrics to identify areas of concern and conducting root cause analysis to understand opportunities to improve performance

Keith Dorricott, MCC Ambassador

Michael Fitzpatrick, Associate Director Clinical Systems and Analytics, Sarepta

Ravin Warnakulasuriya, Senior Director Clinical Development Execution, Vertex  

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 11:00 a.m.

Secrets to Implementing Successful Metric Programs
(Part 2)

11:00 a.m. – 12:00 p.m.

KEYNOTE SESSION

Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution

Kenneth Getz, Director of Sponsored Programs and Associate Professor, Tufts University; Founder and Board Chair, CISCRP

12:00 p.m. – 1:15 p.m.

Lunch

 

The event now splits into two tracks, Vendor Oversight and Risk-Based Quality Management. Please choose the track that will help you the most.

 

VENDOR OVERSIGHT

1:15 p.m. – 2:15 p.m.

WELCOME SESSION

Liz Wool, MCC Ambassador

  • What is Vendor Oversight?
  • What do the Regulatory Authorities Expect: Stories from the Trenches of Regulatory Authority Inspections
  • Normalizing Terminology: Vendor Oversight vs Vendor Management – Are they the same thing?

2:15 p.m. – 3:15 p.m.

PANEL SESSION
Vendor Oversight Approaches and the Keys to Developing “Healthy” Sponsor/Vendor Engagements and Teams

  • Approaches to VO/VM in small, medium and large organizations with a focus on quality and performance
  • Developing a Partnership with Vendors: What are the Key Attributes of the Vendor Staff and Sponsor Staff for ‘healthy’ engagements and teams.

3:15 p.m. – 3:30 p.m.

Break

3:30 p.m. – 4:15 p.m.

CASE STUDY

Vendor Oversight Case Study

4:15 p.m. – 5:15 p.m.

SMALL GROUP EXERCISE

Vendor Oversight Case Example

Instructions:

  • Review the case study
  • Identify the vendors in the case study
  • Identify vendors requiring oversight
  • List 3 things for each vendor that requires oversight

 

RISK-BASED QUALITY MANAGEMENT

1:15 p.m. – 1:45 p.m.

WELCOME SESSION

Keith Dorricott, MCC Ambassador

What challenges organizations are facing when implementing risk-based quality management programs? 

  • What does the term risk-based monitoring mean?  Does is mean risk-based site monitoring or risk-based monitoring at a program/study level?
  • How do you determine Quality Tolerance Limits (QTLs)?
  • How are organizations implementing centralized monitoring?

1:45 p.m. – 2:45 p.m.

PANEL SESSION

Risk Management Emerging Practices and the Impact of ICH E6(R2) Updates

  •  Current risk assessment practices
  • Challenges with risk tools released prior to ICH E6(R2)
  • Realigning methodologies to support review of critical data and critical processes
  • Quality tolerance limits (QTLs)

Nechama Katan, Associate Director, Central Monitoring Pfizer

Sandra Sather, Vice President, Clinical Pathways, LLC

Steve Young, Chief Operations Officer, CluePoints

2:45 p.m. – 3:15 p.m.

PRESENTATION

Normalization of KRIs and QTLs for Risk Detection

Steve Young, Chief Operations Officer, CluePoints

3:15 p.m. – 3:30 p.m.

Break

3:30 p.m. – 4:15 p.m.

PANEL SESSION

Risk-based Site Monitoring Emerging Practices

  • How has implementation of risk-based quality management helped risk-based site monitoring?
  • What risk-based site monitoring models are being implemented?

Duncan Hall, CEO and Founder, Triumph Research Intelligence Ltd.

4:15 p.m. – 5:15 p.m.

BREAKOUT GROUP DISCUSSIONS

  • Risk-based site monitoring Risk-based Quality Management - KRIs & QTLs - Facilitator: Steve Young
  • Risk Management for Small Sponsors - Facilitator: Sandra Sather

 

5:15 p.m. – 6:30 p.m.

Networking Reception

6:30 p.m. – 8:30 p.m.

Member-Only Dinner

 

 

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