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March 2020

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  Important News

 

Measure the Right Things at the Right Time: Using A Metric Maturity Model to Optimize Performance Measurement
Across industries, including the clinical research industry, organizations and their leaders fail to use metrics effectively. They measure too much, too little and/or the wrong things. Measuring the wrong things in clinical trials wastes valuable resources for biopharmaceutical research—both money and time. How do you determine the right things to measure?

A newly released paper 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
 

Participation in MCC member online meetings Jan-Feb 2020 Hits All Time High of 700 registrants!
Participation in MCC online meetings is growing substantially as members work together to share experiences, explore new emerging areas and work to solve common challenges.

During the first two months of 2020, MCC conducted fourteen 1-hour virtual meetings covering the areas of QbD & RBQM, vendor oversight metrics, site selection and study start-up metrics, and imaging-related metrics. The most popular meetings were:  

  1. KRIs the Vital Few [Centralized Monitoring Community of Practice Group]
  2. RBM as Process Control [Centralized Monitoring Community of Practice Group]
  3. Artificial Intelligence / Machine Learning in Clinical Research – An Introduction [AI/ML Community of Practice Group]
  4. Centralized and Site Monitoring Process Metrics
  5. Protocol Operational Complexity (Study Quality Trailblazer Community of Practice Group)

MCC members can view meeting recordings and learn about upcoming meetings by obtaining a user account and logging into the MCC member portal. Registered users receive the MCC Work Group News monthly newsletter with links to register for upcoming meetings as well as work group specific email notices.

To learn more about MCC member online groups, please visit the MCC website or contact MCC.
 

MCC Launches Compliance & CAPA Community of Practice Knowledge Sharing Group on 10 March – First Meeting Open to Public
Interested in participating in cross-industry discussions about compliance & CAPA topics? Join us on March 10th for the first meeting of the newest MCC Community of Practice Knowledge Sharing Group. The purpose of the group is to provide MCC members with a forum to explore leading practices with Compliance & CAPA in clinical trials.

Each meeting will focus on a different topic - with a 20-25 min presentation followed by open discussion and Q&A. Topics suggested by members, include:

  • Categorization of issues / findings and trending
  • Effectiveness checks – theory and practice
  • CAPA process and measurement
  • Linking RBQM and CAPA

Tuesday, 10-Mar-2020 11AM EDT      REGISTER NOW [open to public]

Topic: “Effective Root Cause Analysis”
Presenters:
Sandra SAM Sather – Vice President at Clinical Pathways
Dawn Niccum – Senior Director, QA & Compliance at inSeption Group
 

MCC eCOA Metric Toolkit Update - Join Us on 19 May to Learn About How to Participate in the Update Discussions - First Meeting Open to Public
The use of eCOA methods to collect clinical trial data is rapidly expanding and MCC members have requested that MCC reconvene the eCOA Metric Work Group to discuss possible updates to the metric set.

Meetings are on the third Tuesday of the month at 11am, starting in May. The first meeting is open to the public.

Tuesday, 19-May-2020 11am EDT      REGISTER NOW [open to public]

  • Review existing MCC eCOA Metrics Toolkit v2.0
  • Developments in eCOA and implications for process metrics
  • Plan for process map and metric updates and next steps

MCC Meeting with MCC Ambassadors to Discuss How to Support Implementation of MCC Metric Sets and QbD/RBQM Tools
Beginning this month, MCC will meet with industry consultants on a quarterly basis to provide updates on MCC initiatives and share ideas about how to help MCC members implement MCC metric sets and tools. The MCC Ambassador Network is a network of industry consultants ready to assist your organization with performance metric projects and functional area specific projects.

Members of the MCC Ambassador Network have a minimum of 10 years of experience in the Clinical Research industry, are familiar with MCC metrics sets and tools, and have successfully completed the MCC Metric Boot Camp Program. Many Ambassadors are actively involved with MCC initiatives as subject matter experts, work group facilitators, workshop faculty and more.

Interested in becoming a MCC Ambassador? Please visit  https://metricschampion.org/mcc-partners/mcc-ambassador-network/ for additional details or contact Teresa Holland.

Need to find a consultant? To search for a consultant for your organization’s next consulting engagement, please visit http://metricschampion.org/ambassador-network-search/
 

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2020 MCC Clinical Trial Risk and Performance Management Summit – Call for Abstracts.
Is your organization interested in sharing a case study about using MCC metrics and/or quality tools?

Contact Linda Sullivan, MCC Executive Director, or Keith Dorricott, MCC Ambassador, to learn how your organization can be a part of the 2020 MCC Clinical Trial Risk and Performance Management Summit.

The 2020 Summit will be September 9-10 in Philadelphia. The 2019 Summit was a huge success with themes exploring: Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution, Metric Program Implementation, Risk-based Quality Management, Risk-based Vendor Oversight and Applying Critical Thinking Skills to Utilize Metrics Effectively. Contact Linda or Keith if there are topics you would like to see included for the 2020 Summit and if you are interested in participating as a presenter or panelist. Click here to learn more.
 


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  Member News

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

MCC’s newest members are:

  • O'Keefe Life Sciences, LLC - James O'Keefe

MCC thanks the following members for their renewal:

  • Bluebird Bio
  • Covance
  • CPC Clinical Research (Colorado Prevention Center)
  • Sunovion Pharmaceuticals

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  Work Group

Registration for Initial Meeting of MCC Artificial Intelligence (AI) – Machine Learning (ML) Knowledge Sharing Group Exceeded 80 people – Next Meeting 14 April
The MCC AI/ML Community of Practice – Knowledge Sharing Group was launched to provide MCC members with a place to explore ways to leverage Artificial Intelligence (AI) and Machine Learning (ML) to improve quality and reduce cycle time in clinical trials and help deliver the right drugs to patients who need them.  The group meets every other month and has a dedicated LinkedIn Community and a work group webpage/knowledge portal available on the member portal.

In 2020, MCC plans to host six online meetings during which members can participate in heavily interactive presentations led by industry experts. The topics to be discussed will cover the People, Process and Technology aspects of implementing AI/ML and how they apply to process improvement in clinical trials. The February meeting included a presentation entitled, “Artificial Intelligence / Machine Learning in Clinical Research – An Introduction” by Sagar Anisingaraju (Chief Strategy Officer, Saama Technologies) and Malai Sankarasubbu (VP, AI Research, Saama Technologies). A recording of the presentation and subsequent Q&A and discussion (40 minutes) is available to those in MCC member organizations.  Log in to the MCC site, go to “Meetings and Work Groups” and click on the Artificial Intelligence / Machine Learning Community of Practice. Once there you will be able to play the video.

The 14 April meeting will feature a presentation entitled, “How to design, validate and deploy the AI-driven solution for clinical trials and remain compliant - Dos and Don’ts.” by Artem Andrianov, Ph.D. (CEO and Co-founder, Cyntegrity).

To learn more about this MCC community, please visit the MCC website or contact MCC.
 


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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 Process Metrics
3rd Thursday of the Month at 10AM ET
Mar 19, 2020
Apr 16, 2020
May 21, 2020
Jun 25, 2020*
eCOA Metrics
3rd Tuesday of the Month at 11AM ET
May 19, 2020
Jun 16, 2020
Imaging Metrics
3rd Tuesday of the Month at 10AM ET
Apr 14, 2020* 11AM**
Site Selection and Start-Up Metrics
1st Tuesday of the Month at 10AM ET
Apr 7, 2020
May 5, 2020
Jun 2, 2020
*Meeting date deviates from regularly scheduled frequency.
**Meeting time deviates from regularly scheduled frequency.
 

MCC Communities of Practice
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!

Communities of Practice
Meeting Frequency
Date
Artificial Intelligence (AI)/
Machine Learning (ML)
2nd Tuesday every other Month at 10AM ET
Apr 14, 2020
Jun 9, 2020
Centralized Monitoring
3rd Wednesday of the Month at 10AM ET
Mar 18, 2020
Apr 15, 2020
May 20, 2020
Jun 24, 2020*
Compliance & CAPA
2nd Tuesday every other Month at 11AM ET
Mar 10, 2020
May 12, 2020
Jul 14, 2020
Small Sponsor Community
of Practice
Every other Month at 11AM ET
Apr 21, 2020
Study Quality Trailblazer
2nd Wednesday of the Month at 10AM ET
Apr 21, 2020*
*Meeting date deviates from regularly scheduled frequency.
 

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 Metrics
Jun 10, 2020 10 AM EDT
Central Lab Metrics
Mar 11, 2020 12 PM EDT
Jun 16, 2020 10 AM EDT
Data Management & Biostatistics Metrics
Mar 10, 2020 10 AM EDT
Jun 10, 2020 11 AM EDT
Risk Assessment & Mitigation Management Tool
Mar 12, 2020 10 AM EDT
Jun 17, 2020 10 AM EDT
Site Contracting Metrics
Mar 11, 2020 10 AM EDT
Jun 11, 2020 11 AM EDT
TMF Metrics
Mar 10, 2020 12 PM EDT
Jun 11, 2020 10 AM EDT
Vendor Oversight Finance Metric Toolkit 1.0
Jun 17, 2020 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 at Industry Events 
MCC staff looks forward to having good conversations with you in 2020. Please let us know if you are interested in scheduling a one-on-one meeting at any of the following events.

Clinical Trial Innovation Summit
April 6-8, 2020
Cambridge, MA

Track: Risk-based Monitoring
Presentation: “Is Your Centralized/Onsite Site Monitoring Program Being Implemented per ICH E6(R2)? How Do You Know?”
Session Participant: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Roundtable Discussion: “Implementation of Clinical Development Risk Management”
Session Participants: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium and Jonathan Rowe, Pfizer

Learn More

DIA 2020 Global Annual Meeting
June 14-18, 2020
Washington, D.C.

Track: 02 Clinical Trials and Clinical Operations
Presentation: “Management of Centralized, Remote, and Site Monitoring Models Using Metrics to Improve Process and Oversight”
Session Participant: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Learn More

MCC Clinical Trial Risk and Performance Management Summit
Sept 9-10, 2020
Philadelphia, PA

Please contact MCC Executive Director Linda Sullivan or MCC Ambassador Keith Dorricott if there are topics you would like to see included for the 2020 Summit and if you are interested in participating as a presenter or panelist.

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: We monitor a set of Key Performance Indicators (KPIs) for our strategic partner CRO. They report the KPIs monthly and they are always "green". And yet we know there are many, many issues with the CRO and think performance should be showing as "red". How can there be such a disconnect?

A: There are a number of possibilities that are worth investigating. Since you have not shared what KPIs you are using, we have several suggestions of what to consider:

  1. Check to be sure your KPIs cover different dimensions of oversight - not just time-based but also quality, finance and relationship. Time-based metrics are the easiest to gather and report and, of course, speed is important. But this means that sometimes, the primary KPIs used - even the only KPIs - are time-based ones. Completing activities on time is important - but other requirements such as quality and cost should be monitored to ensure that performance meets your quality standards and/or budget!
  2. Examine the definitions of red, amber and green performance targets. If the KPIs are always showing green and yet the performance is not considered adequate, it could be that the target levels needs modifying.
  3. Review the formulas used to calculate the metrics to determine whether they are averaging results over a long period of time. You could have a situation where current performance is “red” but the overall results are “green” because you are averaging results. If this is the case, you should consider adding metrics that look at recent results as a separate metric. 
  4. Consider what performance questions each KPI answers and why that question is important to answer. All MCC metrics are developed to help answer a question and the reason that question is important is also defined for each metric. If it is not possible to articulate the question and the importance of the question for some of your existing KPIs, you may want to remove them.

The MCC Vendor Oversight Metric Development Work Group developed metric toolkits focusing on four different dimensions of oversight. The last of the four - finance - was released in February 2020. The toolkits include implementation support tools to help you select the right metrics for use as KPIs. This can be based on the question they are designed to answer, the issues you are concerned about, or the metrics other MCC member organizations recommend you consider. It sounds as though this would be a good time to review the existing KPIs and target levels, and make sure they align with your current needs for oversight.


Education icon

  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

© 2020 Metrics Champion Consortium

 
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