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 and Executive Director, Metrics Champion Consortium (MCC)

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
  • 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, Sarepta

Ravin Warnakulasuriya, Senior Director, 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. – 1:00 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

1:00 p.m. – 1:45 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?

1:45 p.m. – 2:15 p.m.

PRESENTATION
Managing the Business of Inefficient Oversight: How Heavy or Light is Your Touch When it Comes to Overseeing Vendors?

Vendor oversight is a hot topic these days as companies try to find implementation strategies to satisfy the ICH E6 (R2) vendor oversight guidelines. From formalized vendor risk-based selection criteria to oversight standard operating procedures to complex vendor management plans, sponsors are interpreting the guidelines in different ways to avoid negative inspection findings at all cost. From all vantages, taking a risk-based approach to vendor oversight makes good sense and should theoretically be more efficient.

  • Do larger companies, with more resources, oversee their vendors less efficiently than smaller companies?
  • Are sponsor resources redoing some of the activities that are sourced to their vendors?
  • How many internal resources are dedicated to vendor oversight activities? In what function do these resources reside?
  • Are centralized vendor oversight functions common practice?

During this session, the speaker will describe current industry practices on the complexities and implementation strategies through interpretation of a detailed survey specific to vendor oversight requirements. The results of this survey will be discussed at this session to spur additional conversation on current practices. In other words, this is vendor oversight: according to you.

Todd Johnson, Principal Consultant, Halloran Consulting Group, Inc.

2:15 p.m. – 3:00 p.m.

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

  • Approaches to vendor oversight/vendor management 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?

3:00 p.m. – 3:15 p.m.

Break

3:15 p.m. – 4:30 p.m.

CASE STUDY

Vendor oversight case study

4:30 p.m. – 5:30 p.m.

SMALL GROUP EXERCISE

Vendor oversight case example

 

RISK-BASED QUALITY MANAGEMENT

1:00 p.m. – 1:30 p.m.

WELCOME SESSION

Keith Dorricott, MCC Ambassador

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

  • What does the term risk-based monitoring mean? Does it mean risk-based site monitoring or risk-based monitoring at a program/study level?
  • How do you determine quality tolerance limits?
  • How are organizations implementing centralized monitoring?

1:30 p.m. – 2:30 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
  • Risk-based quality management in an out-sourced model

Nechama Katan, Associate Director, Central Monitoring, Pfizer

SAM Sather, Vice President, Clinical Pathways, LLC.

Steve Young, Chief Operations Officer, CluePoints

Oleg Shevaldyshev, Associate Director, Quality Assurance, PRA Health Sciences

Kevin Douglass, Associate Director, Process Excellence and Risk Management, Daiichi Sankyo, Inc.

2:30 p.m. – 3:00 p.m.

PRESENTATION

Normalization of Key Risk Indicators and Quality Tolerance Limits for Risk Detection

Steve Young, Chief Operations Officer, CluePoints

3:00 p.m. – 3:15 p.m.

Break

3:15 p.m. – 3:45 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.

3:45 p.m. – 4:30 p.m.

PRESENTATION

Insufficient Data for Centralized Statistical Monitoring: Strategies for Pattern and Unusual Data Detection

Michael Walega, Head of Centralized Monitoring, Bristol-Myers Squibb

4:30 p.m. – 5:30 p.m.

BREAKOUT GROUP DISCUSSIONS

  • Risk-based site monitoring, risk-based quality management – key risk indicators and quality tolerance limits

Facilitator: Steve Young, Chief Operations Officer, CluePoints

  • Risk management for small sponsors

 Facilitator: SAM Sather, Vice President, Clinical Pathways, LLC.

  • Development and use of a Risk Library

Facilitator: Kevin Douglass, Associate Director, Process Excellence and Risk Management, Daiichi Sankyo, Inc.

 

5:30 p.m. – 6:30 p.m.

Networking Reception

6:30 p.m. – 8:30 p.m.

Member-Only Dinner

 

 

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