Event Archives

Event Name Event Description Event Dates Event Location

MAGI’s Clinical Research Conference – 2019 West

Date:   October 27, 2019
Location:  Las Vegas, Nevada

Session Title:  Sponsors of Choice/Sites of Choice: Measuring What Matters

Session Information:

In this working group, we will employ a structured process for defining the key attributes, metrics and performance levels that make a sponsor or site a great partner. This working group is open to people who want to participate, not just observe.

  • Cerdi Beltre – Senior Vice President, Strategic Site Services – WCG
  • Linda Sullivan, MBA – Co-founder and Executive Director, Metrics Champion Consortium

 

Session Title:  Site, Sponsor and CRO Metrics and Benchmarking

Session Information:

Measure the performance of your partners and your own organization.

  • Bishoy Anastasi, MPH MBA CCRP – Director, Clinical Research Finance – University of California, Los Angeles
  • Cindy Carter – President – CenterWatch
  • Michael Farley, BS MBA PMP – Associate Director, Quality and Compliance – Alexion USA
  • Linda Sullivan, MBA – Co-Founder and Executive Director, Metrics Champion Consortium

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10/27/2019-10/27/2019

Las Vegas, Nevada

Risky Business Forum

Date: September 20, 2019
Location: Gilead Sciences, Uxbridge, UK

Session Title: “Risk Evaluation and Control – Meeting the Requirements of ICH E6 (R2) A worked example with Keith Dorricott, Metrics Champion Consortium Ambassador”

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

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09/20/2019-09/20/2019

Uxbridge, UK

Workshop: Building Capacity for Patient-Centered R&D

Date:  September 16, 2019
Location:  Milken Institute School of Public Health at George Washington University, Washington D.C.

Session Title: Measuring Success—What does it look like?

Session Information:

Moderator: Roslyn Schneider

Session objective: Discuss how we can measure outcomes and effectiveness of patient capacity-building efforts and identify what aspects of capacity-building programs contribute to achieving success (e.g., clear focus on target audience, purpose/desired outcomes, method for deploying training, cost/sustainability, multi-stakeholder participation).

  • Matthew May, Programme Coordinator, EUPATI
  • Linda Sullivan, Co-founder and Executive Director, Metrics Champion Consortium

09/16/2019-09/16/2019

Washington D.C.

MCC Clinical Trial Risk and Performance Management Summit

Date: September 4-5, 2019
Location: Philadelphia, PA


Come to the Clinical Trial Risk and Performance Management Summit and discover the secrets to implementing a successful metrics program. You’ll unlock the secrets to deciding what to measure; establishing your data requirements; aggregating reliable data; designing easy to understand metric reports; and using metrics to identify areas of concern and conduct root cause analysis.

Check out this sampling of what you’ll explore over the course of an information-packed day-and-a-half:

  • ICH-E6(R2): This international guideline continues to challenge contract research organizations, sponsors and others. How do regulators use data to determine where to conduct inspections? What challenges has risk-based quality management presented to others? How should you address such challenges? Get ready for answers — from FDA, MHRA and EMA officials as well as industry top thinkers.
  • Squeezing Max Value Out of Data: Do your metrics answer the high-priority questions, reward the right behaviors, give you reliable time/quality readings? Speakers and panelists are ready with answers.
  • Data Quality: Designing data reports end-users can read and understand… aggregating in-house and CRO/vendor data… data governance and stewardship … and much more.
  • Predictive Analytics: Predictive analytics can help you with site selection, quality indicators and more. Discover savvy new ways to apply and test findings.
  • Critical Thinking Skills: Staff can be the weakest link. Discover creative new ways to move away from a ‘check the box’ mentality.

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09/04/2019-09/05/2019

Philadelphia, PA

Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations (public workshop)

Date: July 17, 2019 – 8:30 am to 4:00 pm
Location: Marriott Marquis Washington, DC (Liberty Salons MNOP)

FDA is seeking feedback from stakeholders on the challenges, barriers, and enablers that might be impacting the adoption of RBM, and related opportunities to improve RBM implementation. This public workshop, held under a cooperative agreement with the U.S. Food and Drug Administration, is an opportunity to capture stakeholder input on:

  • The extent to which organizations have implemented risk-based assessment and monitoring, including in conjunction with central monitoring approaches
  • Lessons learned from strategies employed to overcome any obstacles to implementation and to continued execution of RBM
  • Enablers that support implementation and execution of risk-based monitoring
  • How stakeholders assess impact of their RBM program
  • Remaining challenges to implementation or execution that need to be addressed

Session 5: Measuring the Impact of Risk-Based Monitoring Approaches
Session 6: Synthesis and Next Steps

Session Participant: Linda B Sullivan, Executive Director WCG-Metrics Champion Consortium

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07/17/2019-07/17/2019

Washington, DC

DIA Annual Meeting

Date: Tuesday, June 25 • 10:30am – 11:30am
Location: San Diego, CA

Session Title: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
Session Information: This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6 (R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring.

Moderator: Linda B Sullivan, MBA Executive Director, Metrics Champion Consortium

Panelists:
Suzanne Lukac
Senior Account Director, CluePoints

Ann McCabe
Director, Process Excellence and Risk Management, Daiichi Sankyo Inc

Sherry Merrifield
Senior Director, Global Operations Management, Syneos Health

06/25/2019-06/25/2019

San Diego, CA

European Clinical Trials Inspection Readiness Summit

Date: May 16–17, 2019
Location: London, UK

Session Title: Building the Gap Between CAPA and Quality Risk Management to Prevent Systemic-Level Issues

Session Information:

  • Examine the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6 (R2)
  • Explore toolkits developed by an industry consortium that support Quality Risk Management and align with inspector expectations
  • Discuss the importance of documentation of Quality Management decisions and actions for inspection readiness and approaches to achieve this

Session Participation: Keith Dorricott, Ambassador, Metrics Champion Consortium

05/16/2019-05/17/2019

London, UK

Clinical Trial Innovation Summit

Date: May 13–15, 2019
Location: Boston, MA

Session Title: Connecting CAPA Preventative Actions to Quality Risk Management to Reduce Systemic-Level Risks on New and Ongoing Studies

Session Information:

  • Explore the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6 (R2)
  • Discuss the importance of documentation of CAPA Action Plans and Quality Management decisions and actions
  • Describe resources developed by an industry consortium that support CAPA Management and Quality Risk Management

Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium

 

Session Title: Using Site Contracting Performance Metrics in Site Selection—Do You Have Access to the Right Data to Understand How the Site Performed?

Session Information:

  • Explore why site contracting cycle times vary by country
  • Discuss approaches organizations are using to reduce cycle time results
  • Review the data your organization should be reviewing to gain insights about which sites perform well in the context of local regulatory and ethical review requirements

Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium

05/13/2019-05/15/2019

Boston, MA

Evolution Summit Spring 2019 (Invitation only event)

The Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.

Date: February 24–26 2019
Location: The Ritz-Carlton Rancho Mirage, CA

Session Title: The A-Z of Risk-Based Monitoring (RBM): Strategies for the Future

Session Information: As the clinical trials industry continuously evolves, novel strategies must be implemented in an effort to operate efficiently and ultimately accelerate drugs to market. A more centralized, risk-based approach to site monitoring has presented itself as one viable method of reducing costs. Although RBM has been buzzing in the industry for quite some time, its adaptation has been slow. This presentation will shed light on:

  • Implementing a well-designed RBM strategy that enhances, whilst supporting, traditional monitoring approaches
  • Tools needed to execute the strategy
  • Overcoming challenges and the benefits to be realized

Session Participation: Linda B. Sullivan, Executive Director, Metrics Champion Consortium

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02/24/2019-02/26/2019

Rancho Mirage, CA

SCOPE – Summit for Clinical Ops Executives 2019

Date: Tuesday, February 19, 2019 (4:15–5:00 PM)

Interactive Breakout Discussions:
Vendor Performance Metrics and KPIs

  • How effective are your KPIs for measuring vendor performance and quality?
  • What is your strategy for establishing KPIs and metrics? Who are the stakeholders developing performance metrics?
  • What are the key areas that should be evaluated for vendor performance and quality?

Participation: Moderator – Linda B. Sullivan, Executive Director, Metrics Champion Consortium

 

Date: Wednesday, February 20, 2019 (8:55 AM)

Track: Mastering an Outsourcing Strategy

Panel Discussion: Ensuring Harmony between All Stakeholders – Sponsor, CRO, and Site – When Site Sourcing

Topics to be discussed: Working with stakeholders on setting appropriate site budgets, site contracting, site identification, selection of sites, and site oversight/ management

Moderator: Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.

Panelists: Jennifer Trevor, Ph.D., Sr. Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma
Carlos Orantes, CEO, Accel Research Sites
Linda Sullivan, CO-Founder & Executive Director, Metrics Champion Consortium

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02/19/2019-02/20/2019

Orlando, FL

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