Metrics Champion Consortium
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August 2019

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  Important News

Learn the Secrets for a Successful Metric Program at MCC’s Clinical Trial Risk and Performance Management Summit
Want the secrets to implementing a successful metric program? Save your seat at the MCC Summit on September 4-5, 2019 in Philadelphia to discover lessons learned, tips and action plans for addressing your metric program pain points. Four industry presenters, hailing from a wide range of backgrounds and organizational types or sizes, ensures relevance to your pressing metric needs. On day two, put your newly acquired knowledge to the test by taking part in an interactive small-group exercise to cement your understanding and to uncover the root cause(s) of issues described in a fascinating case study. Register today!
 

MCC Site Contracting Metric Toolkit Updated to Include Full Complement of Metric Selection and Implementation Support Tools
MCC Site Contracting Metric Toolkit v1.1 was posted in the MCC member portal on August 16, 2019.

The toolkit includes the following metric selection and implementation supports tools:

  • Tool A: Key Performance Questions to Metrics
  • Tool B: Issues to Metrics
  • Tool C: Basic/Advanced Metrics to Data Elements
  • Tool D: Data Elements to Metrics
  • Tool E: Metrics Reporting Planning Worksheet

The metric definitions have not been modified since their original publication in August 2018. MCC members are invited to download the toolkit by logging into the member portal and clicking on the Existing Metrics Sets tab.
 


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  Member News

MCC welcomes the following new members and thanks those for their continued membership.

MCC’s newest members are:

  • C3 Research Associates
  • iTRIALS
  • Moderna Therapeutics
  • University Health Network

MCC thanks the following members for their renewal:

  • Gianni Benzi Pharmacological Research Foundation
  • ImmunoGen, Inc.
  • Roche / Genentech

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  Work Group

MCC Study Quality Trailblazer and Centralized Monitoring Work Groups to Discuss Implications of Draft Updates to ICH E8(R1)
MCC members are invited to register for the online meeting being held on September 12, 2019 at 10 am EDT.

During the session, Tammy Finnigan, Triumph Research Intelligence, will summarize key aspects of the ICH Harmonized Guideline General Considerations for Clinical Studies E8(R1) draft and the implications of the changes. Following the presentation, there will be an opportunity for participants to share comments and insights.

MCC members can register for this meeting by logging into the member portal and selecting Upcoming MCC Work Group Meetings on the MCC member homepage.


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  Upcoming Meetings

MCC Metric Development Work Groups
Members work collaboratively, through structured discussions, to develop and refine metric sets and tools.

Work group members are encouraged to regularly participate in monthly, 60-minute web-based meetings. On occasion members will be asked to complete structured reviews and provide feedback outside of meetings (assignments typically require 15-30 minutes to complete). To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

 Work Group
Meeting Frequency
Date
Centralized and Site Monitoring Metrics
3rd Thursday of the Month 10AM EDT
Oct 17, 2019
Dec 5, 2019*
Imaging Performance
3rd Tuesday of the Month 10AM EDT
Sep 19, 2019*
Oct 15, 2019
Site Selection and Start-Up Metrics
1st Tuesday of the Month 10AM EDT
Oct 1, 2019
Nov. 5, 2019
Vendor Oversight
1st Wednesday of the Month 10AM EDT 
Sep 11, 2019*
Oct 2, 2019
*Meeting deviates from regularly scheduled frequency.
 

MCC Best Practices Communities
Members share ideas and practical approaches to address challenges unique to these communities.

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

Best Practice Community
Meeting Frequency
Date
Centralized Monitoring
3rd Wednesday of the Month 10AM EDT
Sep 12, 2019*
Oct 9, 2019
Small Sponsor Community
of Practice
Every Other Month 11AM EDT
TBD
Study Quality Trailblazer
2nd Wednesday of the Month 10AM EDT
Sep 12, 2019* **
*Meeting deviates from regularly scheduled frequency.
**Combined Meeting with Centralized Monitoring Work Group.
 

MCC Implementation Support Group Meetings
Members are provided the opportunity to ask questions and share experiences related to implementing specific metric sets or tools at quarterly web-based meetings.

 Metric Set/Toolkit Implementation Q&A
Date & Time
Cardiopulmonary Metric Toolkit v2.1 (ABPM, ECG, Spirometry)
Oct 3, 2019 11 AM EDT
Central Lab Metrics v3.0
Oct 9, 2019 11 AM EDT
Data Management, Biostatistics & Medical Writing Toolkit v2.0
Oct 8, 2019 10 AM EDT
eCOA Metric Toolkit v2.0
Oct 3, 2019 10 AM EDT
Risk Assessment & Mitigation Management Tool v2.0
Oct 10, 2019 10 AM EDT
Site Contracting Metrics Toolkit v1.0
Oct 9, 2019 10 AM EDT
TMF Metrics Toolkit v2.0
Oct 8, 2019 11 AM EDT

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

Connect with MCC
MCC staff looks forward to having good conversations with you in 2019.

MCC Summit Is Fast Approaching – Register Today!
MCC 2019 Summit
September 4-5, 2019
Philadelphia, PA

Discover the secrets to implementing a successful metrics program. You’ll unlock the secrets to deciding what to measure, establishing your data requirements, aggregating reliable data, designing easy to understand metric reports, and using metrics to identify areas of concern and conduct root cause analysis.

A sampling of what you’ll explore during the information-packed day-and-a-half summit includes:

  • ICH-E6(R2): This international guideline continues to challenge contract research organizations, sponsors and others. How do regulators use data to determine where to conduct inspections? What challenges has risk-based quality management presented to others? How should you address such challenges? Get ready for answers from FDA, NHRA and EMA officials as well as industry top thinkers.
  • Squeezing Max Value Out of Data: Do your metrics answer the high-priority questions, reward the right behaviors, give you reliable time/quality readings? Speakers and panelist are ready with answers.
  • Data Quality: Designing data reports end-users can read and understand; aggregating in-house and CRO/vendor data; data governance and stewardship; and much more.
  • Predictive Analytics: Predictive analytics can help you with site selection, quality indicators and more. Discover savvy new ways to apply and test findings.
  • Critical Thinking Skills: Staff can be the weakest link. Discover creative new ways to move away from a “check the box” mentality.

Go to www.mcc-summit.com for more information.

 

Building Capacity for Patient-Centered R&D Workshop
Date: September 16, 2019
Location: Milken Institute School of Public Health at GW, Washington D.C. 20052

Session VI: Measuring Success—What does it look like?
Moderator: Roslyn Schneider

Session objective: Discuss how we can measure outcomes and effectiveness of patient capacity-building efforts and identify what aspects of capacity-building programs contribute to achieving success (e.g., clear focus on target audience, purpose/desired outcomes, method for deploying training, cost/sustainability, multistakeholder participation).

  • Matthew May, Programme Coordinator, EUPATI (invited)
  • Linda Sullivan, Co-founder and Executive Director, Metrics Champion Consortium (invited) 

 

Risky Business Forum
Date: September 29, 2019
Location: Gilead Sciences, Uxbridge, UK

Session Title: “Risk Evaluation and Control – Meeting the Requirements of ICH E6(2). A worked example with Keith Dorricott, Metrics Champion Consortium Ambassador

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

Learn More

 

Clinical Trials Europe
Date: November 21, 2019
Location: Barcelona, Spain

Session Title: “The Impact of Risk-based Quality Management on Vendor Oversight”

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

Learn More


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  Ask the Experts — MCC Answers Your Metric Questions

Meet The Experts

  Keith Dorricott
  MCC Ambassador and Director
  Dorricott Metrics and Process Improvement, LTD




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

Q: My company is working on reducing the time to complete site selection and start-up in order to reduce the overall time to complete our studies. We have successfully reduced the start-up time on a few studies but are noticing an alarming trend – an increase in the number of sites that enroll no or only a single patient. Now we must spend time and money to add more sites to ensure we meet our enrollment goals. Does the MCC have metrics to help us understand this area further and improve our performance?

A: Many organizations focus on reducing study start-up cycle times. Unfortunately, this often results in increased overall study cycle times due to quality issues generated by rushing early processes. In the situation you described, you have sites that are not meeting enrollment expectations. This is not the outcome your organization was seeking! Could this have been prevented if you allowed the teams to spend more time to find better sites during start-up? How do you find the optimal balance of completing tasks quickly and meeting quality requirements? Selecting metrics that reward people for achieving both time and quality goals is a good starting place. This encourages people to “do it right the first time”! MCC metric definitions include suggestions of metrics that should be used together to address this problem. We call these metric groupings “companion metrics”.

If you are interested in learning more about how to use metrics to oversee and manage study start-up, please visit the MCC website to learn about the MCC Site Selection & Start-Up Work Group reconvening in October 2019.


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  Education

MCC’s Learning Institute Helps Improve Clinical Trial Processes and Save Money
Clinical trial performance data can help save millions of dollars in improved processes but only if your people understand how to harness them. MCC’s “Mastering Performance Metrics” eLearning Program helps your key people master performance metrics and eliminate inefficiencies.

Metrics are the key to improving clinical research processes. But without an ability to translate the often overwhelming performance data stream, metrics are useless.

Only people can link the numbers to improved processes and “Mastering Performance Metrics” eLearning courses make that link possible.

These courses use fast-paced audio, video and text to accommodate different learning styles – all on your own schedule. Your team members can choose to take one, two or all three courses as appropriate. All three courses allow you to earn ACRP and SOCRA CE credits and prepare you for Metrics Master Certification.

Click here to learn more about the entire MCC Learning Institute and on the “Mastering Performance Metrics” eLearning Program:

  • MCCe201: The Elements that Make Metrics Effective
  • MCCe202: Developing Effective Metrics Using a Structured Process
  • MCCe203: Effective Metric Visualizations to Gain Valuable Performance Insights

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  MCC Membership and User Accounts

Access to MCC metric sets, tools and other assets are limited to employees of MCC member organizations. Please visit the MCC website or email MCC Membership Director Terry Holland for membership information.

Setting Up User Accounts to Log onto Member Portal
If you work for a MCC member organization, you are welcome to set up an individual user account to take advantage of the benefits MCC Membership offers. Click HERE to start the process.

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Join the MCC LinkedIn Group to learn about industry performance metrics and stay informed of new developments.

 
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Metrics Champion Consortium,  300 N. Washington St.,  Falls Church, VA 22046,  United States 
Phone (617) 948-5100 | Toll free (866) 219-3440

© Copyright 2019 by Metrics Champion Consortium

 
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