MCC Articles
Sullivan LB. Defining “quality that matters” in clinical trial study startup activities. The Monitor. 2011;December: 22-26. [ACRP website]
Mascaro G, Mascaro M. Chapter 16: Metrics champion consortium. In: Hughes G, ed. Central and Core Laboratories. 3rd ed. London, United Kingdom: Biopharm Knowledge Publishing; 2011 [publisher website]
Sullivan LB. Peak performance. International Clinical Trials. 2011;Spring:32-36. [issue] [article]
Robinson R. Standardized development metrics. PharmaVoice. 2009;April:10-15 [article]
Robinson R. Building partnerships around standardized performance metrics. PharmaVoice. 2009;April:16-17. [article]
Henderson L. Metrics gain traction: Metrics Champion Consortium standardizes CRO performance metrics across the board. Applied Clinical Trials. 2008;July [article]
Perkinson JM. Setting standards in metrics management. Scrips. 2006;10-11. [article]
2011 MCC Presentations
8-9 December 2011 - Philadelphia, PA USA
7th Annual Clinical Performance Metrics & Benchmarking Summit
Linda Sullivan, VP of Operations, MCC
10 -11 November 2011 - Berlin, Germany
DIA Quality Risk Management in Clinical Drug Development Conference
Guy Mascaro, President MCC
17 -19 October 2011 - Arlington, VA USA
2nd Annual Quality Oversight of Clinical Vendors
Defining, Implementing and Tracking Quality Metrics to Effectively Oversee Vendor Performance and Clinical Conduct [pdf]
Linda Sullivan, VP of Operations, MCC
19 -21 September 2011 - Boston, MA USA
9th Annual Central Labs
All New Updates on Metrics Champion Consortium Activities - Measuring Effectiveness of Core labs for Better Overall Quality [pdf]
Steve Asbury, Global ECG Coordinator, Eli Lilly and Company
Linda Sullivan, VP of Operations, MCC
8th Annual Project and Portfolio Management for the Drug and Device Industry
Identification and Implementation of Metrics that are Targeted to Assess Quality in Clinical Trials [pdf]
Linda Sullivan, VP of Operations, MCC
19 -21 July 2011 - Philadelphia, PA USA
ExlPharma 3rd Annual Effective Business Development Outsourcing Relationships
MCC Update: Implementing Standardized Clinical Performance Metrics to Manage Risk and Drive Quality in Clinical Trials [pdf]
Jeanne Green, Director of Clinical Operations, ExecuPharm
Dr. Brian O'Neill, External Alliances/Enterprise Systems QRM, F.Hoffman La Roche Ltd.
Linda Sullivan, VP of Operations, MCC
25 - 26 May 2011 - Brussels, Belgium
INFORMA 5th Annual Clinical Operations Summit & 8th Annual Partnering with Central Labs, ECG and Imaging Labs
Performance Metrics & Resource Optimisation Workshop: Utilizing metrics to drive quality management in clinical trials[pdf]
Adopting metrics to guarantee improved performance of your central labs [pdf]
Karolyn Jackson, Global Account Manager, AstraZeneca UK
Implementation of MCC performance metrics to guarantee fair market value at Roche: Imaging
Andrew McDonald, Imaging Outsourcing Specialist, F. Hoffman-LaRoche, Switzerland
22 - 25 May 2011 - Philadelphia, PA USA
MAGI's Clinical Research Conference - 2011 East
Sponsor Operations: (D430) Metrics Champion Consortium Clinical Trial Metrics [pdf]
Marie Hanley, Executive Director, Global Regulatory & Quality Services, Paragon Biomedical, Inc.
Liz Wool, CCRA, CMT, President & CEO, QD-Quality & Training Solutions
4 – 6 April 2011 - Arlington, VA USA
2nd Annual Proactive GCP Compliance Conference
Utilizing Standardized Clinical Trial Performance Metrics to Drive Quality Management in Clinical Trials [pdf]
Guy Mascaro, President, Metrics Champion Consortium (MCC)
Jeanne Green, ExecuPharm and Chair, MCC Process Improvement / Quality Management Working Group
30 March – 1 April 2011 - Phoenix, AZ USA
20th Annual Partnerships in Clinical Trials Conference
Preconference Workshop #5: MCC Clinical Trial Performance Metrics - Improve Timelines, Cost and Quality to Enhance CRO and Sponsor Performance in Clinical Trial Outsourcing Collaborations [pdf]
Gerri Brown-Broadnax, AstraZeneca
Guy Mascaro, MCC
Krishnan Rajagopalan, Cognizant
Dave Zuckerman, Customized Improvement Strategies
26-27 January 2011 – London, UK
8th Annual 20th Clinical Trial Performance Metrics Conference
MCC Update: Focusing on Quality - Protocol Writing, Site Selection and Site Quality Scoring Tools
Dave Zuckerman, Customized Improvement Strategies
A metric isn't anything without communication
Karolyn Jackson, AstraZeneca
2010 MCC Presentations
16-19 November 2010 – Reed Messe, Vienna, Austria
An Industry-wide Effort to Develop and Implement Standardized Clinical Trial Performance Metrics to Drive Process Improvement & Enhance Partnership Performance [pdf]
Guy Mascaro, President, METRICS CHAMPION CONSORTIUM
September 20-22, 2010. Hyatt Regency, Boston, MA USA
Performance Metrics Adoption and Integration Lessons from MCC Members to Improve Trial Operations [pdf]
Guy Mascaro, President, METRICS CHAMPION CONSORTIUM
Julie DeBus-Levy, Manager, Outsourcing and Contracts, ABBOTT LABORATORIES
Debbie Walton, MS, MBA, CPM, Relationship Manager, Central Labs and Diagnostics, MERCK
September 20-21, 2010. Hyatt at the Bellevue, Philadelphia, PA USA
UPDATE FROM THE MCC: Understanding How Pharmaceutical, Biotechnology and CROs Develop Standardized Metrics to Drive Process Improvement and Boost Partnership Performance in Clinical Trials [pdf]
Linda Sullivan, Vice President of Operations, METRICS CHAMPION CONSORTIUM
September 9th – 10th, 2010. Kempinski Hotel Bristol Berlin, Germany 
Using Quality Metrics to Drive Direction for Process Improvement Methodologies and Fundamentally Improve the Clinical Drug Development Process [pdf]
Eli Alford, Director, Global Operations Management, INC RESEARCH USA
Keith Dorricott, Director, Quality Improvement, i3 UK
August 2 - 3, 2010. Silver Springs, MD USA
Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public Workshop
Feasible quality systems approaches – using metrics effectively
Linda Sullivan, Vice President of Operations, METRICS CHAMPION CONSORTIUM
July 26-28, 2010. San Diego, CA USA 
Industry-wide Efforts to Develop and Implement Standardized Clinical Trial Performance Metrics to Drive Process Improvement [pdf]
Eli Alford, Director, Global Operations Management, INC RESEARCH
Linda Sullivan, Vice President of Operations, METRICS CHAMPION CONSORTIUM
July 13 - 14, 2010. Arlington, VA USA
MCC UPDATE: How the Industry-Wide Effort to Develop and Implement Standardized Clinical Trial Performance Metrics Helps BD’s Relationship with their Clients [pdf]
Part I: MCC Update: MCC Clinical Trial Performance Metrics, Quality Scoring Tools and Industry Database
Guy Mascaro, METRICS CHAMPION CONSORTIUM
Part II: Utilizing metrics to improve clinical trial performance and strengthen sponsor/CRO relationships
Elizabeth Shewell, INCYTE CORPORATION
Part III: Incorporating performance metrics into contracts to be used to better manage sponsor/CRO relationships and improve business outcomes
Gary Urban, PARAGON BIOMEDICAL
May 3-5, 2010. Paris, France / May 25-26, 2010. Boston, MA USA
eClinical Forum Spring Workshop
An Industry-wide Effort to Develop and Implement Standardized Clinical Trial Performance Metrics to Drive Time, Cost and Quality & Enhance Partnership Performance … UPDATE!
[pdf]
Pam Howard, ICON CLINICAL RESEARCH - Paris workshop
Patti Nash, NEW ENGLAND RESEARCH INSTITUTE - Boston workshop
April 12-14, 2010. Orlando, FL USA
Pre-Conference Workshop B4: MCC Clinical Trial Performance Metrics – An Industry-wide Effort to Develop and Implement Standardized Performance Metrics to Drive Time, Cost and Quality & Enhance Partnership Performance … UPDATE! [pdf]
Speakers:
Cory Gutterman, Assoc. Director, Outsourcing, Global Pharmaceutical R&D, ABBOTT LABORATORIES
Guy Mascaro, President, METRICS CHAMPION CONSORTIUM
Mike Minor, VP Proposals and Business Information, ICON CLINICAL RESEARCH
Breakout Group Facilitators:
Jennifer L. Holmes, RPh, Global External Sourcing Relationship Manager Global Medical R&D, ELI LILLY & COMPANY
Paul Colvin, RPh, Senior Vice President, Clinical Development, North America, PPD
Jeanne Green, RN, MS, CCRA, Director of Clinical Operations, EXECUPHARM INC
March 23-24, 2010. Philadelphia, PA USA
METRICS CHAMPION CONSORTIUM UPDATE [pdf]
Deploying Process Improvement and Quality Metrics that Fundamentally Improve the Clinical Trial Drug Development Process
Keith Dorricott, Director, Quality Improvement, I3 RESEARCH
Linda Sullivan, Vice President of Operations, MCC
Dave Zuckerman, President, CUSTOMIZED IMPROVEMENT STRATEGIES
February 3-5, 2010. San Fransicso, CA USA
February 4, 2010
Track C: Oncology Case Studies and Therapeutic Area Round Tables
Implementation of Imaging Metrics to Monitor Oncology Studies
Natasha F. Homji, MS, Study Manager II, Oncology Imaging, NOVARTIS PHARMACEUTICALS
February 5, 2010
MCC LAB, ECG and Imaging Metrics Adoption, Implementation and Updates
Guy Mascaro, President, MCC [pdf]
Julie DeBus-Levy, Manager, Outsourcing and Contracts, ABBOTT LABORATORIES [pdf]
Pia Strannelind, Global Account Manager, Technology, ASTRAZENECA
Natasha F. Homji, MS, Study Manager II, Oncology Imaging, NOVARTIS PHARMACEUTICALS
2009 MCC Presentations
CBI’s Inaugural Conference on Contracting for CROs: Meet the Increasing Need for Strategic Proposal Development and Metrics-Driven Execution for Collaborative Partnerships with Sponsors December 2 - 3 , 2009 • Philadelphia, PA
An Industry-wide Effort of Pharmaceutical, Biotechnology and Service Providers to Develop and Implement Standardized Performance Metrics to Drive Process Improvement and Enhance Partnership Performance
Linda B. Sullivan, VP Operations, Metrics Champion Consortium [pdf]
Results of the Clinical Trial Metrics Initiative — Industry Collaboration with Service Providers
Cory Gutterman, Associate Director, Global Clinical Outsourcing, Abbott Laboratories [pdf]
Mike Minor, Vice President, Proposals and Business Information, ICON Clinical Research [pdf]
An Industry-wide Effort of Pharmaceutical, Biotechnology and Service Providers to Develop and Implement Standardized Clinical Trial Performance Metrics to Drive Process Improvement and Enhance Partnership Performance [pdf]
Linda Sullivan, Vice President of Operations, METRICS CHAMPION CONSORTIUM
· Gain Knowledge about Sponsor and CRO Industry Efforts to Develop Standardized Performance Metrics to Improve Clinical Trial Operations, Including Sponsor, CRO and Site Processes
· Learn About a Draft Set of Standardized Clinical Trial Performance Metrics Developed by a Group of Biotechnology, Pharmaceutical and CROs in the MCC
· Case Study: Review How Sponsors and Service Providers are Utilizing the MCC ECG Performance Metrics to Improve Processes and Strengthen Sponsor/ECG Core Lab Relationships
How the Industry-Wide Effort to Develop and Implement Standardized Clinical Trial Performance Metrics Helps BD's Relationship with their Clients [pdf]
Cory Gutterman, Assoc. Director, Outsourcing, Global Pharmaceutical R&D, ABBOTT LABORATORIES
Guy Mascaro, President, METRICS CHAMPION CONSORTIUM
Mike Minor, VP Proposals and Business Information, ICON CLINICAL RESEARCH
In this session, presenters discuss the growing need for standardized performance metrics, the industry's efforts to develop metrics, and how organizations are using metrics to drive improvements. Specifically, Business Development professionals and others with customer contact have the opportunity to:
· Review a draft set of standardized Clinical Trial metrics developed by a group of Biotechnology, Pharmaceutical and CRO organizations in the MCC.
· Learn how sponsors and CROs utilize the metrics to improve clinical trial performance and strengthen sponsor/CRO relationships
· Discuss ways that performance metrics can be successfully incorporated into contracts to be used to better manage sponsor/CRO relationships and improve business outcomes
Partnerships with CROs & Other Outsourcing Providers [April 28-30, 2009 Orlando, FL]
April 28, 2009 - B1: MCC Metrics Full Day Workshop - release MCC Clinical Trial Performance Metrics (beta version)
Overview of Metrics Champion Consortium (MCC) - Guy Mascaro [pdf]
Developing a Metrics Program: Utilizing Industry Best Practices - Dave Zuckerman [pdf]
MCC Metrics Development Process and Clinical Trial Performance Metrics (beta) announcement - Cory Gutterman [pdf] [Click here to view MCC Clinical Trial Performance Metrics (beta version)]
MCC Clinical Trial Performance Metrics: Workgroup Breakout Session
Case Study: Implementing Performance Metrics – Incorporating Performance Metrics into CRO Contracts - Lorraine Waring [pdf]
MCC Clinical Trial Performance Metrics: WRAP-UP PANEL
Moderator:
Cory Gutterman, Associate Director Outsourcing, ABBOTT LABORATORIES
Workshop Faculty:
Kathe Balinski, Vice President, Clinical Operations, MEDAREX
Guy Mascaro, President, METRICS CHAMPION CONSORTIUM (MCC)
Lorraine Waring, Senior Director, Contracts & Outsourcing, PFIZER
David Zuckerman, President, CUSTOMIZED IMPROVEMENT STRATEGIES
Julie Szabo, MS, Director, Clinical Research, PHARMANET DEVELOPMENT GROUP
Plenary Session: Current and Future Metrics Champion Consortium Metrics Initiatives
[pdf]
Guy Mascaro, President, METRICS CHAMPION CONSORTIUM (MCC)
Sue Hwang, Senior Manager, R&D Global Strategic Sourcing, AMGEN
Steve Asbury, Global ECG Coordinator, ELI LILLY & COMPANY
David Rauh, Clinical Diagnostic Services Imaging Management, ELI LILLY & COMPANY
Track B: Standardization in Imaging Studies - Metrics Champion Consortium Imaging Performance Metrics Announcement
[pdf]
David Rauh, Clinical Diagnostic Services Imaging Management, ELI LILLY & COMPANY
Track C: Improving and Standardizing ECG and Cardiac Safety Studies - Using the MCC ECG Metrics
[Lilly/Quintiles Case Study]
Jeffrey Litwin, MD, Chief Medical Officer & EVP, ERT
Steve Asbury, Global ECG Coordinator, ELI LILLY & COMPANY
Track A: Central Lab Relationship Development - Overview of Metrics: Definition Refinement & Update from the Central Lab MCC Initiative
[pdf]
Sue Hwang, Senior Manager, R&D Global Strategic Sourcing, AMGEN
Cynthia Lindemann, Central Laboratory Coordinator, Clinical Diagnostic Services, ELI LILLY & COMPANY
Alissa Kerry, Sr. Manager, Business Process Measurements, Covance Central Laboratory
Linda Sullivan, VP Operations, METRICS CHAMPION CONSORTIUM (MCC)
Full-Day Pre-Conference Workshop: MCC (Metrics Champion Consortium) - Implementing Performance Metrics to Drive Time, Cost and Quality & Enhance Partnership Performance
Karolyn Jackson, Global Account Manager, AstraZeneca, UK
David Zuckerman, President, Customized Improvement Strategies, LLC, USA
AstraZeneca, Quintiles Laboratories and eRT experience on the implementation of MCC Laboratory and ECG metrics
-
Review of the MCC metrics: laboratory and ECG
-
Metrics selection process: establishing sponsor & supplier requirements
-
Compiling & presenting the metrics: examples of data and placing data into context
-
Working with the metrics to drive improvement: lone task or joint venture
Karolyn Jackson, Global Account Manager, AstraZeneca, UK
Pia Strannelind, Global Account Manager, Technology AstraZeneca, Sweden
Alexander Kant, Quintiles
Bob Bailey, ERT
2008 MCC Presentations
Featured Speakers
State of the Industry: Issues facing Sponsor and CRO organizations in the clinical trial arena [Larkin pdf]
Jay A. Turpen, Director, Strategic Clinical Sourcing, Eli Lilly and Company
Sean P. Larkin, Senior Executive Vice President, The Americas, Late Stage Development PharmaNet
MCC CRO Performance Metrics Initiative: Overview of Metrics Development Process [pdf]
Cory Gutterman, Associate Director, Outsourcing, Abbott Laboratories,
Chair, MCC CRO Performance Metrics Steering Committee
MCC CRO Work Group Metrics Development Mapping Tool [pdf]
David Zuckerman, President,Customized Improvement Strategies, LLC,
Workgroup Breakout Sessions
Attendees participated in breakout groups to review draft MCC CRO Metrics and propose additional metrics related to specific areas of interest, including:
-
Biostatistics & Data Management
-
Business Operations & Finance
-
Clinical Operations, Medical Writing, & Project Management
DIA Conference: MEDICAL IMAGING CONTINUUM - Path Forward for Advancing the Uses of Medical Imaging in the Development of New Biopharmaceutical Products [Oct 2 - 3 2008 Bethesda, MD ]
Overview of the Metrics Champion Consortium (MCC): History and Methodology [pdf]
David Rauh, Eli Lilly and Company
Operations WG on Metrics Characterizing the Execution of Clinical Trials, Logistics [pdf]
Antoinette A. Chan, PhD, Amgen, Inc.
Kevin Jaynes, Perceptive Informatics
Outsourcing Performance Metrics Working Group [pdf]
Dawn E. Flitcraft, CNMT, RDMS, Bio-Imaging Technologies, Inc.
Clinical WG on Metrics Characterizing Central Image Acquisition and Analysis [pdf]
Helen Young, PhD, AstraZeneca
James J. Conklin, MS, MD, ICON Medical Imaging
Implementation Work Group Sessions
How to use MCC metrics to improve operations & client relationships (service provider perspective): R. Kent / Quintiles (May 1,2008) [view session]
How to initiate implementing MCC metrics with your service provider partners (sponsor perspective): C. Schmittlein / AstraZeneca (June 5, 2008) [view session]
Workshop B1. Implementating Performance Metrics to Drive Time, Cost and Quality & Enhance Partnership Performance (April 14, 2008)
MCC CRO Workshop Participant Survey [pdf]
Part I: Overview & MCC Update [pdf]
Part II: Utilizing Industry Best Practices [Pendell pdf] [Zuckerman pdf]
Part III: ECG Case Study [pdf]
Part IV: Breakout Groups [contact Linda Sullivan]
MCC Case Study: Implementation of MCC Central Lab Performance Metrics
Plenary Session - Using Performance Metrics to Strengthen Partnerships & Increase ROI [pdf]
Case Study: Practical Approach to Implementation and Utilization of MCC ECG Metrics [pdf]
MCC Leader Update: Lilly, Amgen & Merck Detail Their Efforts to Standardize Performance Metrics for Imaging Core Labs [pdf]
January 9, 2008 --
MCC ECG Performance Metrics Web Conference
2007 MCC Presentations
IIR Conference: Pharmaceutical Metrics Event (October 16 - 18, 2007 Cambridge, MA).
MCC Industry Advisory Board Breakfast Meeting [PDF]
Case Study: Using Metrics to Improve the Management of your Sponsor/Provider Relationships -- An ECG Services Example.
IIR Conference: Imaging in Clinical Trials (September 24-25, 2007 San Francisco, CA).
Changing Paradigms: How to Build Partnerships between Sponsors and Imaging Core Labs
MCC ECG Performance Metrics Webcast [view session]
IIR Partnerships with CROs [April 10-12, 2007 Orlando, FL]
Workshop B1: Implementing Performance Metrics to Drive Time, Cost and Quality & Enhance Partnership Performance
Part I: Overview [pdf] Part II: Benchmarking Metrics [pdf] Part III: Eli Lilly/Quintiles Case Study [pdf] Workshop Summary [pdf]
IIR Partnering with Central Labs, ECG and Imaging Core Labs [January 17-19, 2007 Anaheim, CA]
Workshop B5: Metrics in Action: Lessons Learned from Implementation of MCC Metrics [pdf] [Case Study pdf]
MCC ECG Performance Metrics Announcement [pdf]
Review of the MCC ECG Performance Metrics [pdf]
Drive Change! Imaging Metrics Discussion Forum [pdf]
2006 MCC Presentations
5th Annual Pharmaceutical Performance Measurement Event
[November 8-9, 2006 Philadelphia, PA]
Overview and Update on Metrics Champion Consortium (MCC): A Collaborative Effort to Jointly Improve Performance
Sponsor Perspective: Measuring and Comparing Performance of Service Providers
Provider Perspective: How the Use of Metrics Can Help Develop Solid Business Relationships with Sponsors
DIA 42nd Annual Meeting [June 20, 2006 Philadelphia, PA]
Metrics Champion Consortium: How to Get Engaged Brian P. Schrock [Eli Lilly & Co.] [
Presentation ]
Implementing the Performance Metrics for Central Laboratories: Service Provider Perspective
James R Dixon [Covance Central Laboratory Services] [ Presentation ]
Annette Balog, BS. MBA [Quintiles Laboratories] [ Presentation ]
Kick-off of ECG Performance Metrics Initiatives
Nenad Sarapa, MD [Daiichi Sankyo] [ Presentation 1 ] [ Presentation 2 ]
Standardizing Central Laboratory Performance Metrics [ Webcast February 3, 2006 ]