Clinical Trial Risk and Performance Management Summit

Day1
PLENARY SESSION

7:30 a.m. – 8:45 a.m.

Breakfast

8:45 a.m. – 9:00 a.m.

Welcome

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

  • 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, Contractor for the Metrics Champion Consortium; Director, Dorricott Metrics & Process Improvement Limited

Michael Fitzpatrick, Associate Director, Sarepta

Ravin Warnakulasuriya, Senior Director, Vertex Pharmaceuticals

Nancy Dynes, Metrics Consultant, Eli Lilly and Company

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 11:00 a.m.

Secrets to Implementing Successful Metric Programs (continued)

11:00 a.m. – 12:00 p.m.

KEYNOTE ADDRESS

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

  • 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?

Liz Wool, President, Wool Consulting Group, LLC

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 riskbased selection criteria to oversight SOPs to complex vendor management plans, Sponsors are interpreting the guidelines in different ways to avoid negative inspection findings at all costs. From all vantages, taking a risk-based approach to vendor oversight makes good sense and should theoretically be more efficient … but is it?

  • 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.

Margaret Sabe, Principal Consultant, Halloran Consulting Group, Inc.

2:15 p.m. – 3:00 p.m.

PANEL

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

Mary Brantner, Senior Director, Mallinckrodt Pharmaceuticals

Maria Makarovskaya, Clinical Outsourcing Consultant, Voyager Therapeutics, Inc.

Michele Weitz, Senior Director, Clinical Standards and Innovation, Clovis Oncology

Leslie Sam, Independent Consultant, Former TransCelerate Member

3:00 p.m. – 3:30 p.m.

Break

3:30 p.m. – 4:15 p.m.

CASE STUDY

An Evolving Approach to CRO Oversight — Challenges, Lessons and Takeaways

  • A sponsor describes its journey with oversight via metrics — going from theory to practice
  • Challenges including cultural and change management aspects are presented
  • Learn how to focus your oversight metrics on the vital few and some potential pitfalls in implementation

Jehan Poco, Manager, DSI

David Anderson, Manager, DSI

4:15 p.m. – 5:30 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

5:30 p.m. – 6:30 p.m.

NETWORKING RECEPTION

6:45 p.m. – 8:30 p.m.

MCC Member Dinner

 

RISK-BASED QUALITY MANAGEMENT

1:00 p.m. – 1:30 p.m.

WELCOME

  • 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 (QTLs)?
  • How are organizations implementing centralized monitoring?

Keith Dorricott, Contractor for the Metrics Champion Consortium; Director, Dorricott Metrics & Process Improvement Limited

1:30 p.m. – 2:30 p.m.

PANEL

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

  • Risk-based quality management in an outsourced model
  • Risk libraries — benefits and challenges
  • Practicalities of risk assessment — critical process, critical data, critical thinking

Sandra (SAM) Sather, MS, BSN, CCRA, CCRC Vice President, Clinical Pathways, LLC

Steve Young, Chief Operations Officer, CluePoints

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

Kevin Douglass, Associate Director, DSI

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. – 3:30 p.m.

Break

3:30 p.m. – 4:15 p.m.

PANEL SESSION

Risk-Based Site Monitoring Emerging Practices

  • How has site monitoring changed under RBQM?
  • What challenges are there in integrating new RBQM roles into existing structures?
  • Planning versus reacting to data: What site monitoring can we plan up-front and how much has to depend on what we find during the course of a trial?

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

Arturo Morales, Chief Technology & Data Officer, WCG Analgesic Solutions

Diane Thornton-Chandler, Principal Centralized Clinical Research Specialist, MC2 Global Monitoring, Medtronic

4:15 p.m. – 5:30 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

Risk-Based Site Monitoring and Risk-Based Quality Management — KRIs & QTLs

Steve Young, Chief Operations Officer, CluePoints

Risk Management for Small Sponsors

Sandra (SAM) Sather, MS, BSN, CCRA, CCRC Vice President, Clinical Pathways, LLC

Development and Use of a Risk Library

Kevin Douglass, Associate Director, DSI

Keeping the Risk Assessment Up to Date

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

5:30 p.m. – 6:30 p.m.

NETWORKING RECEPTION

6:45 p.m. – 8:30 p.m.

MCC Member Dinner

 

 

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