MCC eCOA Performance Metrics Set v1.0 Now Available

Monthly Archives: November 2016

MCC eCOA Performance Metrics Set v1.0 Now Available

Wednesday, November 23, 2016

MCC member companies have developed an initial set of eCOA Metrics to measure the quality, timeliness and effectiveness of their setup, use and closeout of eCOA services. Utilization of these metrics will enable organizations to understand how well the process is being executed and managed throughout study start-up, conduct and closeout. The eCOA metric set and a number of supporting reference tools are available to MCC members.

MCC eCOA Performance Metrics v1.0 At-A-Glance

MCC Performance Metrics

An overview presentation of the metrics was recorded and has been posted on the MCC Members Website.

Presentation Outline

  • Background – MCC eCOA Working Group Purpose, Deliverables and Approach
  • Overview of MCC Metrics Development Model
  • Overview of the eCOA Critical Success Factors
  • Overview of the eCOA Map
  • Overview of the Key Performance Questions
  • Overview of the eCOA Performance Metrics

eCOA Performance Assets Available to Download from the MCC Member Website

  • A recorded eCOA Basics Webinar
  • Recorded eCOA Overview Presentation
  • eCOA Metrics Process Map
  • Detailed MCC eCOA Performance Metric Definitions (Wiki Terms are included with the metrics definitions)

MCC Members can access all of these resources by clicking the Member Login link and going to the Existing Metric Sets section of the website. Scroll down to the table of existing metric sets.

Please contact Linda Sullivan for additional information.

Learn more about membership options and register to become a member of the MCC

For questions about membership options contact MCC Membership Director, Teresa Holland.

CluePoints Partners with Metrics Champion Consortium to Define Metrics and Standards for Centralized Monitoring

Monday, November 7, 2016


Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) and Risk-Based Monitoring (RBM) solutions for clinical trials, announces its partnership with the Metrics Champion Consortium (MCC), an association dedicated to the development of standardized performance metrics to improve clinical trials. Drawing on the company’s vast expertise in Risk-Based Monitoring, CluePoints will work with the consortium to help drive collaboration in the development of a standardized framework for Central Monitoring, including identification and definition of what is included, who should be involved, and how best to manage the process.

“We are excited to have the opportunity to lead such an important initiative for the Metrics Champion Consortium” comments Steve Young, Senior Vice President of US Operations at CluePoints. “The industry is finally beginning to move forward to large scale adoption of RBM, yet there remain many questions on the topic of Central Monitoring, and so we look forward to driving clear guidance and standards for this critical component of RBM success.”

The Metrics Champion Consortium has created the Central Monitoring work group to help facilitate the exchange of knowledge and expertise in standardization of clinical risk management. Known for organizing work groups with the intention of providing metrics for the clinical trials industry, MCC has engaged CluePoints to work with them to more clearly define what Central Monitoring is for the industry.

“We are delighted that CluePoints will lead our Central Monitoring work group” comments Linda Sullivan, Co-Founder and President of Metrics Champion Consortium. “Results from our recent Risk-based Approaches to Monitoring Industry Survey show an increasing number of organizations use/plan to use central monitoring approaches in the next 12 months as compared to two years ago. This new MCC work group will bring sponsors, CROs, central & core labs, consultants and IT system vendors together to explore what key risk indicators, performance metrics and data should be included in central monitoring, what analytic approaches should be used to gain valuable insights and how organizations should use the insights to ensure patient safety and improve data quality. CluePoints’ experience with centralized monitoring and risk-based monitoring make the company ideally placed to bring the community together to share insights and align thinking to established, shared global standards.”

About CluePoints

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

For further information on CluePoints’ solutions, please visit

Media contact

Patrick Hughes – Chief Commercial Officer, CluePoints

+44 (0) 7703 532 749

About the Metrics Champion Consortium

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

For more information about MCC publications, metric sets & tools, metric education programs and how you can participate in future surveys and MCC work groups, please visit


Linda B. Sullivan – President, Metrics Champion Consortium

1.317.622.0266 ext 102