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September 2020

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  Important News

MCC’s Clinical Trial Risk and Performance Management Virtual Summit Receives High Marks!
The MCC Risk and Performance Management Virtual Summit had a record number of attendees view presentations and participate in “virtual” discussion groups 8-10 September 2020. We have received very positive feedback about the topics covered as well as the experience of participating in virtual discussion groups that used white board technology to gather input and share knowledge.

The keynote session, A Regulatory Compliance Perspective on Improving Clinical Trial Quality, Protection of Trial Participants, and Data Integrity featured the return of speaker Dr. Jean Mulinde, Policy Advisor from the FDA’s clinical compliance evaluation division, CDER to the MCC Summit. During her session, she shared her thoughts about the following topics:

  • What clinical research industry stakeholders should keep in mind when implementing quality-by-design and risk-based quality management programs,
  • Whether FDA has seen a shift in inspectional findings that suggest good clinical practice compliance and data quality are improving,
  • How CDER uses submission data to quantify risk to determine where to conduct BIMO inspections, and
  • The impact of the COVID 19 pandemic on clinical trial quality

At the end of her presentation, Dr Mulinde presented a case example When the “Quality Journey” You Embarked on Saves the Day. The example highlighted the importance of quality by design and risk-based monitoring and the value of having good documentation. In her closing remarks, she challenged the audience to shift our thinking - to move away from concern about implementing RBM to what will happen if you don’t embrace and implement QbD and RBM and FDA raises data integrity issues that traditional monitoring methods did not identify?

Summit participants can view presentation recordings, download presentations and discussion group working papers from the Summit website. A summary report will be provided to attendees later this year.

For additional information about the MCC Summit, please visit https://www.centerwatch.com/mcc-summit-2020

MCC Members Have Opportunities to Share Knowledge at Upcoming Online Meetings

 Work Group
Topic
Date
Artificial Intelligence / Machine Learning CoP
Intelligent Machines take on Clinical Data Management
Ashley Howard, Pfizer & Sagar Anisingaraju, Saama
24-Sep-2020
10-11am EDT
Centralized Monitoring CoP
The Best Metrics for QTLs – Follow on From MCC vSummit Working Group
21-Oct-2020
10-11am EDT
Centralized & Site Monitoring Process Metrics
What Are the Challenges with Site & Centralized Monitoring Set-Up?
15-Oct-2020
10-11am EDT
Compliance & CAPA CoP
The Importance and Challenges of Determining Issue Severity
Oleg Shevaldyshev, PRAHS
12-Nov-2020
10-11am EDT
eCOA Process Metrics
What Matters in the eCOA Process? Determining our Key Performance Questions
20-Oct-2020
10-11am EDT
Inspection Readiness / TMF CoP
“Hear First-Hand Experience of a Remote Inspection and Learnings”
Barbara Novak, Kyowa Kirin
22-Sep-2020
10-11am EDT
Site Selection & Start-up Metrics
Site Start-Up – Efficiency and Quality Metrics Brainstorm
6-Oct-2020
10-11am EDT
MCC Metric Toolkit – Implementation Q&A
Cardiopulmonary, Data Management, Site Contracting, RAMMT, Vendor Oversight, Imaging, Central Lab
29-Sep-2020 to
8-Oct-2020
Additional information about all of the MCC work groups can be found on the MCC website.

These are member-only groups. Registration links are available on the Upcoming Meetings Webpage in the MCC Member Portal. For additional information about MCC membership options or to find out if your organization is a MCC member, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland.
 

Class of 2020 MCC Champions Recognized at the MCC Summit
MCC2020ChampionImageMCC Champion is a special honor bestowed upon individuals who made significant contributions to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials. Please join me in congratulating this year’s class of MCC Champions.

Sagar Anisingaraju (USA)
Frank Berger (Germany)
Colleen Cox (USA)
Steve Crow (UK)
Laurie Halloran (USA)
Brett Hoover (USA)
Katherine Johnson (USA)
Barbara Mumma (USA)
Dawn Niccum (USA)
Barbara Novak (USA)
Emily Ricketts (USA)
Elvin Thalund (USA)
Gary Tyson (USA)
Alec Vardy (USA)
 

MCC Clinical Trial Optimization Podcast – 3 New Episodes Available!
PhoneTestImageThe MCC Clinical Trial Optimization Podcast 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 in a twice-monthly podcast. For more information about the podcast and to view a full listing of show episodes please click here

EPISODE 4 – The Upside of Centralized Monitoring During a Pandemic: Linda Sullivan, Duncan Hall, and Rachel Oakley on Optimizing Clinical Trials through Innovative RBQM Technology  Listen Now

EPISODE 5 - Striving for Reliability: Optimizing Patient-Reported Data through World-Class Design Management with Linda Sullivan, Nat Katz, and Art Morales  Listen Now

EPISODE 6 - The Case for Centralized Monitoring: Optimizing Data Quality and Risk Management with Linda Sullivan and Steve Young  Listen Now

Subscribe today! Apple Podcasts             Spotify            Stitcher          Android
 

MCC Announces a New Community of Practice Group for Consultancy Members
ConsultantsMCC will unveil a Consultancy Community of Practice (CoP) resource webpage in the member portal during the CoP online meeting on 28 September 2020. The group meets on a quarterly basis to discuss What’s New @ MCC, share knowledge and gather feedback about MCC metric sets and tools.

Additional information about the MCC Consultancy Community of Practice Group can be found on the MCC website.  MCC Members can log onto the MCC member portal to register for the session.

If you are interested in learning more about MCC membership options for solo consultants and consultancy groups, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland.


Member news icon

  Member News

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

MCC newest members are:

  • Bioforum
  • Chiesi Farmaceutici
  • Oriel Research Services – Brigid Flanagan
  • Science37

MCC thanks the following members for their renewal:

  • Accenture Accelerated R&D
  • ERT

Working group icon

  Featured Work Group

Inspection Readiness / TMF Community of Practice
MagnifyGlassPeople-BlackImageCase Study: A Virtual Sponsor Inspection: Experiences and Learnings

MCC members are invited to join us on 22 September to continue the discussion about virtual/remote inspections. During this meeting, Barbara Novak of Kyowa Kirin will share her experiences with a recently completed remote inspection and the learnings.

Additional information about the MCC Inspection Readiness / TMF Community of Practice Group can be found on the MCC website. MCC Members can log onto the MCC member portal to register for the session.


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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
Oct 15, 2020
Nov 19, 2020
eCOA Process Metrics
3rd Tuesday of the Month at 10AM ET
Oct 20, 2020
Nov 17, 2020
Site Selection and Study Start-Up Metrics
1st Tuesday of the Month at 10AM ET
Oct 6, 2020
Nov 3, 2020
Dec 1, 2020

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
Sep 24, 2020
Oct 13, 2020
Centralized Monitoring
3rd Wednesday of the Month at 10AM ET
Oct 21, 2020
Nov 18, 2020
Compliance & CAPA
2nd Tuesday every other Month at 10AM ET
Nov 12, 2020
Jan 12, 2021
Inspection Readiness/TMF
Quarterly
Sep 22, 2020
Small Sponsor Community
of Practice
Every other Month at 11AM ET
TBD
Study Quality Trailblazer
2nd Wednesday of the Month at 10AM ET
TBD
*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.

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
Date & Time
Cardiopulmonary Metrics
Sep 29, 2020 10AM EDT
Central Lab Metrics
Oct 8, 2020 10AM EDT
Data Management & Biostatistics Metrics
Sep 29, 2020 11AM EDT
Imaging Process Metrics
Oct 7, 2020 11AM EDT
Risk Assessment & Mitigation Management Tool
Sep 30, 2020 11AM EDT
Site Contracting Metrics
Sep 30, 2020 10AM EDT
Vendor Oversight
Oct 7, 2020 10AM EDT
 

Connect with MCC at Industry Events 
MCC staff looks forward to having good conversations with you in 2021.

WCG-MCC Clinical Trial Risk and Performance Management Virtual Summit
See you September 2021


Ask icon

  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: At the MCC Virtual Summit, there was discussion about Quality Tolerance Limits (QTLs). I can see how there could be many areas we could use QTLs but at the discussion, using around 3-5 seemed to be recommended. Couldn’t we use many more to have even better control of the quality and risks in our studies?

A: Thank you for joining us at the MCC Virtual Summit. We had a fascinating discussion at the Working Group you mention which was led by Leslie Sam of Wool Consulting. The Working Group discussed parameters (aka metrics) that organizations are monitoring when implementing Quality Tolerance Limits, and some of the challenges with those metrics. You’re right that for companies using QTLs, most use around 3-5 per study. One of the reasons that organizations are monitoring a small number of QTL parameters and thresholds is that ICH E6 (R2) section 5.0.7 requires that important deviations from QTLs and associated remedial actions be reported in the Clinical Study Report. However, the approach to using metrics to monitor study risks and setting thresholds is certainly worth considering beyond a small number of “key” ones with associated QTLs. As part of Centralized Monitoring, it is common to use Key Risk Indicators (KRIs) to look at site-level risks, for example. And it would be possible to monitor further risks at study- or program-level using metrics with thresholds. This topic will be discussed in more detail in the MCC Centralized Monitoring Community of Practice group.


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  Education

Clinical Pathways Performance Management and GCP On-Demand eLearning Courses Added to MCC Learning Institute Offerings
InteractiveeLearningMCC is pleased to announce the expansion of the eLearning courses available in the MCC Learning Institute. Specifically, twelve new performance management and GCP eLearning courses offered by Clinical Pathways are featured in the MCC Learning Institute. MCC has a well-established relationship with Clinical Pathway’s co-founder and Vice President SAM Sather and her team as they helped us develop the MCC Mastering Performance Metrics eLearning courses. Clinical Pathway’s expert staff are certified clinical research professionals with degrees in nursing and education with over 30 years of training development and presentation experience for medical device, pharmaceutical, and biologic research. Clinical Pathways has developed convenient and affordable off-the shelf training to meet sponsors’, CROs’ and sites’ needs. All Clinical Pathways eLearning trainings are in an on-demand, interactive format for training on the go. 

  • Courses use real-life case scenarios to help you understand how it applies to your career.
  • Each course comes with a certificate of completion as evidence of your training for audit readiness.

Don’t miss this chance to learn new skills today!  Visit the MCC Learning Institute for additional details.


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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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