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June 2019

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  Important News

MCC’s Clinical Trial Risk and Performance Management Summit is September 4–5, 2019 in Philadelphia
Discover the secrets to implementing a successful metrics program by choosing one of two tracks, vendor oversight or risk-based quality management. Listen to 14 industry experts, problem solve through breakout sessions, network with your peers and participate in demos. Early bird discount ends on July 25. Register today!
 

MCC Metric Selection Tools Available to Help Organizations Determine Which MCC Metrics to Use
MCC members have used a facilitated, structured approach to develop an extensive library of 300 portfolio, study and site level time – quality – cost metrics. How do you decide which metrics to use in your program?

MCC is adding four metric selection tools to MCC metric toolkits. View the six-minute webinar to learn more!
 

Clinical Operation Metric Update to Begin July 2019
MCC is establishing two work groups – Monitoring Metric Work Group (centralized and site monitoring metrics) and Site Selection & Start-Up Metrics Work Group (site selection, start-up and activation metrics).

MCC will begin the clinical operation metric updating process by focusing on two areas: monitoring and site start-up. MCC will gather information about performance management and metric usage in the two areas over the summer in preparation for launching the online work group meetings in October 2019. MCC members interested in participating in the metric update discussions can sign up for the work groups by selecting the appropriate option in your online user profile. MCC members can register for either of the October launch meetings on the MCC website.

Not an MCC member? Contact MCC Membership Director Terry Holland for information on becoming an MCC member.
 

Small Sponsor Knowledge Portal Launched to Support Small Sponsor Community of Practice
On June 4, MCC unveiled a new online Small Sponsor Knowledge Portal that includes resources such as short videos, implementation guides and links to relevant MCC resources.

The knowledge portal was established to provide a newly forming Small Sponsor Community of Practice with a single place to find MCC resources and for community members to share case studies, templates, etc.

The Community of Practice will meet online on a bi-monthly basis to:

  • Share ideas and practical approaches that work in small sponsor settings
  • Get up-to-date news about MCC Performance Metric Sets and Tools
  • Provide feedback about how MCC can support small sponsors
  • Learn from their peers

Halloran Consulting and other members of MCC community who work with smaller-sized sponsors have offered to participate in the online meetings to share insights and facilitate discussions. MCC will conduct a brief survey to gather input about future topics to be discussed by the members of the community of practice.
 

Clinical Operations Performance Management - Are You Measuring the Right Things?
To quote the late Michael Hammer in his famous article The 7 Deadly Sins of Performance Measurement: “…many of the operational metrics that companies commonly use make little or no sense.”

Many organizations have measurement programs to monitor process performance in clinical trials. But often, the metrics used have just been added to over time. Do you know why you are measuring what you measure? What do you do with the results? Are there other more important metrics you should be considering?

View the one-hour webinar to learn how the MCC’s metric sets and new metric selection tools will help you select the right metrics to help your business.


Member news icon

  Member News

MCC Membership Increasing as Consortium Welcomes New Members
MCC welcomes the following new members and thanks those for their continued membership.

MCC’s newest members are:

  • Akebia Therapeutics
  • Oracle

MCC thanks the following members for their renewal:

  • Accenture Accelerated R&D Services
  • Gilead Sciences

Working group icon

  Featured Work Group

Centralized Monitoring WG Explores Data Review (‘Data Cleaning’) vs. Centralized Monitoring
During a well-attended meeting on May 15 (63 attendees representing 25 organizations), MCC member representatives Johann Proeve (Cyntegrity) and Steve Young (CluePoints) led an interactive discussion comparing Centralized Monitoring and Data Management/Review activities.

The topics discussed included:

  • How the two areas complement each other – ensuring data is clean as well as using data to predict the future and estimate risk
  • The different tasks for each role including site monitoring and safety/medical
  • The importance of ensuring actions taken are effective
  • Whether different roles have different requirements for freshness of data
  • Risk reviews – their frequency and also the need for cross-functional participation; Areas beyond CM have data and a perspective on risk, too

An 11-minute recap webinar is available on the MCC member portal in the Centralized Monitoring Work Group webpage.


Calendar icon

  Upcoming Meetings

MCC Monthly Work Group Meetings
Meetings are open to participants from MCC member organizations. To register for a work group meeting or for a detailed list of meeting dates and times, 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 at 10AM EDT
Oct 17, 2019
Dec 5, 2019
Centralized Monitoring
3rd Wednesday of the Month at 10AM EDT
Jun 19, 2019
Jul 17, 2019
Sep 25, 2019*
Oct 16, 2019
Imaging Performance
3rd Tuesday of the Month
at 10AM EDT
Jun 18, 2019
Jul 16, 2019
Site Selection and Start-Up Metrics
1st Tuesday of the Month at 10AM EDT
Oct 1, 2019
Nov 5, 2019
Small Sponsor Comm of Practice
Every Other Month at 11AM EDT
TBD
Study Quality Trailblazer 
2nd Wednesday of the Month
at 10AM EDT
TBD
Vendor Oversight
1st Wednesday of the Month 
at 10AM EDT 
Jul 10, 2019*
Sep 11, 2019*
Oct 2, 2019
*Meeting deviates from regularly scheduled frequency.
 

MCC Metric Sets and Tools Implementation Support Group Meetings
These newly created meetings will be held on a quarterly basis to provide MCC members the opportunity to ask questions and share experiences related to implementing specific metric sets or tools.

 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

 

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

MCC’s Linda Sullivan Looks Forward to Connecting With You During DIA
DIA Annual Meeting
Tuesday, June 25, 2019 10:30am - 11:30am
San Diego, CA

Session Title: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring

Session Information:

  • This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6(R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring

Moderator

  • Linda B Sullivan, MBA Executive Director, Metrics Champion Consortium

Panelists:

  • Suzanne Lukac, Senior Account Director, CluePoints
  • Ann McCabe, Director, Process Excellence and Risk Management, Daiichi Sankyo Inc.
  • Sherry Merrifield, Senior Director, Global Operations Management, Syneos Health

MCC Staff Invite You to Attend the 2019 Clinical Trial Risk and Performance Management Summit
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 report, 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 include:

  • ICH-E6(R2): This international guideline continues to challenge contract research organizations, sponsors and other. 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.


Ask icon

  Ask the Experts

MCC Answers Your Metric Questions
Q: We have been doing some analysis on the percentage of subjects enrolled (actual vs. expected) metrics defined in the MCC Clinical Trial Performance Metrics v1.3. The calculation is defined at the study level. How do you calculate this across a portfolio of studies?

Meet The Experts

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




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

A: MCC is expanding the metrics defined at a portfolio level (across studies) as the metric sets are being updated. We are planning to update the CTPM v1.3 set of metrics later this year. In the meantime, I recommend you be careful about averaging results across studies. In doing so, you are not taking account of the study size: e.g. the average could include one study with 100 patients planned that is at 150% and another with 2,000 patients planned that is at 80%. The average is 115% but what does that really tell you? You need to understand the question you are seeking to answer when you develop portfolio level metrics. 

The MCC Vendor Oversight Work Group explored different ways to aggregate study level data when they developed portfolio-level milestone metrics. They defined metrics that compared results by looking at the percentage of milestones that were met:

  • For all studies from their start date
  • During a specific period of time slice – such as a three-month period
  • For each study
  • For each study phase (start-up, conduct, closeout)

A similar approach could be used with the percentage of subjects enrolled – so long term and recent performance can be reviewed. Instead of study phase, you could group results by therapeutic area.


Education icon

  Education

MCC Congratulates Two Metric Master Certification Graduates
Please join us in congratulating Michel Meyers (Takeda Pharmaceutical) and Scion Li (Takeda Pharmaceutical) on the successful completion of the Metrics Champion Consortium Metric Master Certification program.

To earn this designation, they each completed three MCC online courses:

  • 201-Elements that Make Metrics Effective,
  • 202-Developing Effective Metrics Using a Structured Process and
  • 203-Effective Metric Visualizations to Gain Valuable Performance Insights

Additionally, they demonstrated metric knowledge through the completion of a Metric Master Certification Applied Learning Project and presented results to an MCC Advisor.

To learn more about the MCC Metric Master Certification Program, please visit the MCC website or contact MCC Customer Service.


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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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