News & Press

Topic: News & Press

What are the best MCC Performance Metrics for assessing Vendor Performance?

Tuesday, February 21, 2017

MCC is launching a Vendor Oversight work group on March 1st to review and revise MCC Performance Metrics for assessing vendor performance. This new work group will focus on reviewing previously defined metrics related to business operations, clinical operations and quality. The group will also consider the impact of ICH E6 (R2) on these metrics, modifying and adding to the MCC Performance Metrics as needed.

Planned outputs for the group include agreeing on the scope of vendor management, identifying Critical Success Factors and Key Performance Questions, and developing basic and advanced sets of MCC Performance Metrics. The meetings will be held the first Wednesday of the month from 10-11am. Work group meetings are open to all MCC members and registration links can be found on the member portal.

To find out more about the Vendor Oversight group, view the work group page by clicking HERE.

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.

MCC Special QM Webinar, “How Regulators are Supporting the Quality Management and Risk Based Procedures in ICH GCP E6 (R2)” featuring guest speaker Ann Meeker-O’Connell, Former FDA Director of the Division of GCP Compliance.

Wednesday, February 1, 2017

The International Conference on Harmonisation’s R2 addendum to the ICH E6 Guideline for Good Clinical Practice (GCP) provides direction on a new approach to clinical monitoring and trial management that requires the use of centralized, quality risk management (QRM) throughout a clinical trial. Sponsors and CROs that are adapting to the changes are approaching this in a variety of ways. That leads to the question, what will regulators expect from organizations as they integrate the new guidelines into their SOPs?
The presentation on January 11th , open to all MCC members, focused on the processes and behaviors that the FDA and other regulators are promoting through the quality management and risk-based guidance in ICH-E6(R2) section 5.0 Quality Management. This should be of interest to all organizations whether you have already integrated the changes into your practices or are just starting to plan for the integration.

MCC Members can access this and other Subject Matter Expert Webinars by clicking the Member Login link and going to the MCC Initiative Updates section of the Member Homepage. Scroll down and click on the SME Webinars link.

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.

Ann Meeker-O’Connell heads Bioresearch Quality and Compliance for Johnson & Johnson’s consumer sector with responsibility for Good Clinical Practice (GCP), Good Laboratory practice (GLP) and Safety Vigilance oversight. Prior to J&J, Ann served as Director of the Division of Good Clinical Practice Compliance at the U.S. Food and Drug Administration (FDA). At the FDA, Ann led Agency initiatives related to innovative models for clinical trial conduct and oversight, advised on clinical trial policy and regulation development, and oversaw FDA’s GCP collaboration with European Medicines Agency (EMA). Ann earned her Bachelor’s in Biological Anthropology and Anatomy and a Master of Science in Pharmacology from Duke University in Durham, NC.

Join the MCC Clinical Trial Metrics Community LinkedIn Group Today!

Tuesday, August 11, 2015

The MCC Clinical Trial Metrics Community LinkedIn group has over 550 members. Click here to join the MCC Clinical Trial Metrics Community LinkedIn Group.

Why join the group?

• Learn what’s new at the MCC

• Stay up to date the latest information from industry professionals

• Share your exciting and relevant news or events

• Post a metric question for group discussion

Get the latest MCC updates by joining the Metrics Champion Consortium company page. Click here to follow the company page.

For more information, please contact Linda Sullivan via LinkedIn or at lsullivan@metricschampion.org.

MCC Raleigh-Durham, NC Complimentary Breakfast Meeting on April 17

Wednesday, April 1, 2015

Join the Metrics Champion Consortium (MCC) for a complimentary breakfast meeting and learn how you and your organization can benefit from a MCC membership. If you’re already a member, learn what’s new!

The event will take place from 8:00 AM to 10:30 AM on Friday, April 17, 2015 at the Marriott at Research Triangle Park.

CLICK HERE TO REGISTER NOW

There will be special presentations by Linda B. Sullivan, Co-founder & President of MCC, and Tammy Finnigan, MCC Risk-based Monitoring Work Group Leader, and COO of Triumph Consulting Services.

Discussion topics include: updated standardized performance metrics, quality management systems, new metric sets and much more.

Registration is required for these meetings. Contact customerservice@metricschampion.org for more information.

MCC is Pleased to Introduce You to the MCC Ambassador Network

How do you find the right consultant for your organization? The MCC is here to help!

The MCC Ambassador Network consists of qualified industry consultants who are ready to assist your organization. These consultants have a minimum of 10 years of experience in clinical research, are familiar with MCC metrics sets and tools, and have successfully completed the MCC Metric Boot Camp Program. Additionally, many are actively involved with MCC initiatives as subject matter experts, work group facilitators, workshop faculty, and more.  Network Ambassadors can assist you with performance metric projects (strategy, change management and implementation) as well functional specific projects such as vendor selection, vendor assessments, risk management, risk-based monitoring, quality management, QA audits, and eTMF implementation.

“Over the years, I have received numerous inquiries from MCC members requesting metric implementation assistance. People are looking for consultants with practical functional area expertise, metric strategy, and implementation knowledge. Building the Ambassador Network has been a long term goal that we are pleased is coming to fruition,” says Linda Sullivan, Co-Founder and President of MCC.

Search the MCC Ambassador Network Database to find the resources you need for your next project.

Version 2.0 of MCC’s Protocol Development Quality Scoring Tool launches today!

Monday, December 8, 2014

Version 2.0 of MCC’s Protocol Development Quality Scoring Tool launches today! All MCC members are invited to attend a webinar noon-1 p.m. EST to learn how their protocol development process could be improved using this new tool. (The webinar will be posted and available for viewing after its conclusion.)


The Microsoft Excel®-based tool provides protocol development teams with a set of questions for reviewers to consider in the protocol review process and a means to score (1) protocol design quality, (2) protocol feasibility quality and (3) editorial quality.


The tool generates four scores: an overall score and three sub-scores (design, feasibility and editorial quality), that provide the development team a means to check whether the protocol is ready for approval. Each score reflects how well these aspects of protocol composition and review were conducted: Who should have participated in composition/review vs. those that did participate?; What was the nature/quality of their contributions?; What proportion of the critical review elements/questions were considered by each reviewer, and how thoroughly and were data applied?;  and Did the protocol development team incorporate/address reviewer comments?


Ultimately, the tool helps sponsors gain approval of quality protocols that can be successfully executed with few, if any, amendments.


Get the Free White Paper Now!

Survey: What do you think about the proposed CAPA metrics set?

Tuesday, November 4, 2014

MCC needs your voice! Please take a new online survey about a proposed set of CAPA process and outcome metrics.

The survey is in advance of an upcoming, members-only meeting. During the online meeting, members will review a draft CAPA process map. The survey results will add to the discussion of which CAPA Process Metrics members are interested in adding to the MCC Clinical Trial Performance set.

All individual survey responses will be confidential. Aggregated survey results will be presented to MCC members November 10th, 2014.

Central laboratory analysis of samples

Friday, October 31, 2014

October’s Metric of the Month focuses on a key performance metric collected and reported by central labs. Central laboratory analysis of samples collected by the investigational sites is an important source of safety and efficacy endpoint data.

Take a look at MCC Lab Performance Metric v2.1 #7

  • the percentage of “reportable” tests (e.g. percentage of tests not cancelled due to sample issues)

CLICK HERE for the full article.