MCC Articles
Standardized Development Metrics [PharmaVoice April 2009]
Metrics Gain Traction: Metrics Champion Consortium standardizes CRO performance metrics across the board. [Applied Clinical Trials July 2008]
Setting Standards in Metrics Management [Scrips 2006]
2010 MCC Presentations
April 12, 2010
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 24, 2010
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 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 ]