Topic: Publications

MCC White Papers

MCC’s Metric Development Framework Defines Metrics That Answer Key Performance Questions

Monday, April 12, 2021

Successful performance metrics focus on what drives success across the enterprise. They help answer important questions. They have a purpose. Don’t measure things simply because you can, or that aren’t a concern for your organization. That may sound obvious, but many organizations measure things that simply don’t matter. Just because something is a problem for a competitor, or you heard it mentioned at a conference, doesn’t mean that the associated metric is meaningful to your trial or for your processes. You face challenges unique to the types of trials you’re running and the processes you have adopted. You cannot afford to waste resources on collecting, reporting and analyzing metrics that don’t answer your questions.

Learn more – podcast and download the paper.

MCC’s Clinical Trial Optimization Podcast Show Launched July 13 – Subscribe Now!

Wednesday, July 15, 2020

MCC is pleased to announce the launch of the Clinical Trial Optimization a twice-monthly podcast that brings together clinical research stakeholders to exchange ideas, share knowledge, and think creatively about how to oversee, manage and optimize clinical trial planning and execution.

Subscribe today!

Apple Podcasts





The podcast includes discussions with clinical research industry thought leaders and practitioners about how the industry is transforming clinical research design and operations to speed up the delivery of life-changing therapies. It is geared toward clinical research professionals, including R&D executives, clinical operations managers, study managers, data scientists, quality assurance managers, biostatisticians, principal investigators, clinical research associates (CRAs), safety monitors, clinical scientists and other healthcare professionals.


Impact of COVID-19 with Laurie Halloran


Drug Development with Ken Getz

To catch future episodes visit the MCC Clinical Trial Optimization Podcast page.


MCC Article Looks at Bridging the Gaps in CAPA Planning and Clinical Trials

Thursday, May 21, 2020

MCC’s latest article “Bridging the Gaps in CAPA Planning in Clinical Trials,” published by Applied Clinical Trials gets to the root of why identifying and implementing preventive actions in clinical trial corrective and preventive action (CAPA) plans gets lost in the shuffle.  The article, written by Linda B. Sullivan, Executive Director, WCG – Metrics Champion Consortium, encourages connecting CAPA and risk-based quality management (RBQM) to enable real-time learning about existing risks as they evolve, in addition to ongoing identification of emerging issues and potential threats.

Read the article on Applied Clinical Trials Online (log in may be required).

New Paper! Measure the Right Things at the Right Time Series

Monday, May 4, 2020

MCC released the second paper in a new Measure the Right Things at the Right Time series. The paper Design Key Risk Indicators and Key Performance Indicators that Provide Timely Insights During Study Conduct outlines an approach to and rationale for the best way to normalize metrics used as leading indicators to provide early signals of risk, such as with Key Risk Indicators, as part of Risk-Based Quality Management in implementation of ICH E6 (R2). How you define your measurements can allow you to see trends and outliers earlier as well as reduce the number of false positives!  View the paper

The first paper in the series Using A Metric Maturity Model to Optimize Performance Measurement describes a 5-stage metric maturity model that align metrics with process maturity stages. Learn how your organization can realign your metric program to focus on measuring meaningful, high value metrics.  View the paper

For a complete listing of free downloadable MCC White Papers click here.

MCC MetricInsights Newsletter Launch

Friday, June 16, 2017

The MCC recently released a monthly Newsletter. The MetricInsights Newsletter provides professionals with updates on MCC events and key initiatives. It’s all the important news for the month in one place. Sections include Important News, Featured Workgroup, Upcoming Meetings, and More! We are always adding and changing sections so every issue has something new! Read past issues and learn how to subscribe here .

MCC Article Urges Industry to Standardize Data Entry Metric Definition and Use Performance Data to Improve Data Entry Compliance

Wednesday, April 26, 2017

Linda Sullivan, MCC President, and Keith Dorricott, MCC Ambassador – discussed the results of the 2016 MCC Site Data Entry Practices Survey in their article “Importance of Data Entry Timeliness” published by Applied Clinical Trials. The article reveals that organizations consider timely data entry to be very important but face challenges with measuring and monitoring the data input process. A newly released MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies” provides industry’s perspective on the cycle time from subject visit to data entry by investigative sites, and how organizations use the performance data to improve data entry compliance.

About the Survey

MCC conducted the 28 question, web-based survey between June – August 2016. There were 35 respondents primarily from sponsors and Contract Research Organizations (CROs) both large and small. For more information on purchasing this and other MCC Industry Practices Insight Reports, please email Customer Service
or visit our Industry Practices Insights Report Page

Read Linda Sullivan and Keith Dorricott’s article on Applied Clinical Trials Online

Performance Metrics: New eLearning Course Allows You to Go Beyond the Basics

Tuesday, April 25, 2017

MCC introduces a new eLearning course, Performance Metrics: Developing Effective Metrics Using a Structured Process that offers industry professionals a deeper understanding of how to select and use performance metrics to support a company’s strategic goals.

Using case study examples and easy-to-use worksheets, professionals will learn to use the MCC Metric Development Framework to establish metrics that align with each level of responsibility in your organization and support program goals and objectives. This easy to follow approach includes the following features:

  • Utilizing processes map to identify control points for metrics
  • Establishing critical success factors
  • Prioritizing key performance questions
  • Defining metrics that answer the key performance questions
  • Reporting metric results in formats that facilitate answering the key performance questions

The price of this course is $560* for members and $699 for non-members. There is also accreditation for 2 hours of CEUs accepted by ACRP and SoCRA.

* Discount code needed. For questions please contact Customer Service

MCC President Linda Sullivan shares insights related to ICH-GCP E6(R2) in Clinical Informatics News Article

Friday, February 17, 2017

Linda Sullivan shared her insights on the major updates to the International Guidelines for Clinical Trials in an article entitled “New GCP R2 Guideline Emphasizes Risk Management Through People, Process, And Technology” by Ann Neuer posted in Clinical Informatics News. Linda speaks on how the new update supports organizations moving to tracking and reporting critical data rather than meaningless data in clinical trials. Click here to read the full article.

Significant Growth—67% Increase Over Past Two Years—in the Use of RBM in Pivotal Clinical Trials

Thursday, October 20, 2016

Boston, MA., October 20, 2016—Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—announced today a newly published report, “An Updated Look at Risk Assessment and Risk-based Management Practices,’ revealing the industry’s acceptance of risk-based monitoring across all phases of clinical trials and regions. The report also features new content on the use of formal risk assessment as a tool for identifying causes of risk that could affect the collecting of critical data or the performance of critical processes prior to a clinical trial.

Among the key findings:

  • Top sources organizations use for project/protocol review is EDC (83%), CTMS (66%), and Central Labs (60%)
  • Majority of organizations are conducting risk assessments prior to study conduct (69%)—fewer are repeating assessments during study conduct
  • Use of web portals and secure document exchange has increased to 56% in 2015, up from 36% in 2013
  • Top reasons organizations are implementing RBM shifted from reducing monitoring costs-78% in 2013-to improving quality oversight (83%) and data quality (85%) in 2015
  • Traditional 100% SDV monitoring decreased from 75% in 2013 to 62% in 2015

“The significant increase in the use of risk-based monitoring approaches signals that the industry has moved from the early adopter to the early majority innovation adoption phase,” said Linda Sullivan, co-founder and president at the industry group Metric Champion Consortium, author of the new report.  “Additionally, our analysis shows that the data analytic approaches being utilized to support risk management and RBM programs are growing in sophistication and will continue to do so in the next 12 months. Standardizing performance metrics are the linchpin that support these analytic platforms.”

MCC conducted the online survey between November 2015 and January 2016 as a follow-up to the seminal work piloted by MCC in 2013, the first survey to examine organizational approaches and e-data sources driving risk-based monitoring (RBM) programs.
For more information on purchasing the “An Updated Look at Risk Assessment and Risk-based Management Practices,” please email or visit

About Metrics Champion Consortium (MCC)

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

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

Linda Sullivan

MCC CAPA Process Performance Metrics Set v1.0 Now Available

Monday, June 27, 2016

MCC member companies have developed a set of CAPA Metrics that measure the quality, timeliness and effectiveness of an organization’s CAPA process.  The CAPA metric set and a number of supporting reference tools are available to MCC members.

An introductory presentation was recorded and has been posted on the MCC Members Website.

The presentation follows the following outline:

Background – MCC CAPA Working Group Purpose, Deliverables and Approach

  • Overview of MCC Metrics Development Model
  • Overview of the CAPA Critical Success Factors
  • Overview of the CAPA Process Map
  • Overview of the Key Metrics Terms
  • Overview of the CAPA Performance Metrics.

 CAPA Performance Assets Available to Download from the MCC Member Website

  • Recorded Presentation
  • PowerPoint Slides of the Presentation
  • CAPA Process Map
  • Detailed MCC CAPA 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, logging in and going to Existing Metric Sets section of the website.  Scroll down to the table of existing metric sets.

To learn more about membership options or to register to become a member of the MCC please CLICK HERE or contact MCC Membership Director, Teresa Holland.