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February 2019

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  Important News

MCC Risk Management Fundamentals eLearning Course 301 is Available – Register Today
Does your organization understand risk and how to implement risk management in your clinical research program? MCC is pleased to announce that MCC eLearning Course 301 – Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management is available for purchase in the MCC store (MCC members receive a 20% discount).

This course is an expanded, upgraded version of a complimentary live webinar presented by Linda Sullivan, MCC Co-Founder and Executive Director, and Keith Dorricott, MCC Ambassador, in October 2018. Due to the overwhelming response and positive feedback, the webinar content was expanded into a one-hour, hands-on, on-demand training course during which Linda and Keith walk through risk management concepts, and learners apply the concepts by reviewing a case example and completing the risk assessment and control log included in the course material.

At the conclusion of the course, learners are be able to:

  • Explain the concept of risk and its management
  • Describe risk management in clinical research and the relevance of ICH E6(R2)
  • Identify critical data and processes and use process maps to identify areas of risk
  • Develop risk statements and evaluate risk
  • Describe approaches to controlling risks in clinical research
  • Mitigate some common implementation challenges

You have to develop and implement risk-based quality management programs to comply with ICH E6(R2). You owe it to yourself to discover how. Register today.
 

Save the Date! MCC’s 2019 Summit will be held Sept 4-5, 2019 in Philadelphia
MCC’s 2019 Clinical Trial Risk and Performance Management Summit will take place at the Lowes Hotel in Philadelphia. More information will soon be released. The 2018 summit was a huge success! Don’t miss out on this year’s meeting. MCC members receive a registration discount. Contact MCC for additional information.
 

Vendor Oversight Group Finalizing Quality Oversight Metrics and Preparing to Begin Financial Oversight Consideration
Work group participants reviewed feedback from MCC member organizations of the draft set of 15 quality-related metrics for oversight. The work group decided to look into four additional quality-related metrics before discussing metrics related to finance.

The work group agreed to consider adding the following metrics related to:

  • Actions completed on time
  • Timely audit response
  • Percentage of CRO key staff approved with conditions
  • Key staff turnover

“Discussing the metric feedback led to some lively and interactive discussions,” said Vendor Oversight Work Group facilitator and MCC Ambassador Keith Dorricott. “The work group really gets everyone thinking about what is important in oversight and how best to measure.”

The work group then discussed metrics related to finance starting with an overview of Earned Value Analysis and whether costs are inline with what is expected.

The Vendor Oversight Work Group meets the first Wednesday of each month and is open to MCC members. MCC members can click here for more information.


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  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:

  • Jazz Pharmaceuticals

MCC thanks the following members for their renewal:

  • ACM Global Laboratories
  • Bayer Healthcare
  • Janssen / Johnson & Johnson
  • Pfizer
  • Regeneron Pharmaceuticals

Correction: In last month’s Metric Insights, we incorrectly listed the name of MCC Ambassador Ed Campanaro’s business. The business name is Clinical Trials Consulting Services - CCTC Services. We apologize for the error.


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  Featured Work Group

Which Metrics Should I Select? Central Lab Tools Help You Select the Right Metrics
The Central Labs Work Group has been developing tools to help with selection of metrics. They have used the comprehensive set designed for the Site Contracting metrics as a starting point and are very pleased with the results to date.

One of the tools the work group is most proud of helps to recommend metrics based on issues that you have (or risks you have identified) and then highlights recommended metrics and the data elements that are needed to calculate those metrics. An excerpt from the tool below shows how it works. Two issues have been selected and the recommended metrics are highlighted in green.

At the February work group meeting, team members expanded on the issues and associated metrics. This tool will help organizations implement the metrics that will have the most benefit. This is one of a number of methods the MCC has developed to help organizations select the right metrics.

MCC members can register for future Central Lab Work Group meetings by logging into the MCC site. Contact group facilitator and MCC Ambassador Keith Dorricott for more information about the Centrals Labs Work Group.


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  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
Central Lab
1st Tuesday of the Month at 10AM EDT
Mar 5, 2019
Apr 2, 2019
Central Monitoring
3rd Wednesday of the Month at 10AM EDT
Feb 28, 2019*
Mar 20, 2019
Apr 17, 2019
May 15, 2019
Jun 19, 2019
Imaging Performance
3rd Tuesday of the Month
at 10AM EDT
Mar 19, 2019
Site Selection & Start-Up
2nd Thursday of the Month
at 10AM EDT
TBD
Study Quality Trailblazer 
2nd Wednesday of the Month
at 10AM EDT
Mar 27, 2019*
Vendor Oversight
1st Wednesday of the Month 
at 10AM EDT 
Mar 6, 2019
Apr 3, 2o19
May 1, 2019
Jun 5, 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)
Mar 13, 2019 10 AM EDT
Data Management, Biostatistics & Medical Writing Toolkit 2.0
Mar 12, 2019 10 AM EDT
eCOA Metric Toolkit v2.0
Mar 13, 2019 11 AM EDT
Risk Assessment & Mitigation Management Tool v2.0
Mar 14, 2019 11 AM EDT
Jun 13, 2019 11 AM EDT
Site Contracting Metrics Toolkit 1.0
Mar 14, 2019 10 AM EDT
Jun 13, 2019 10 AM EDT
TMF Metrics Toolkit 2.0
Mar 12, 2019 10 AM EDT
Jun 11, 2019 11 AM EDT

 

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

MCC’s Linda Sullivan to Present at the Evolution Summit
MCC Co-Founder & Executive Director Linda Sullivan will present The A-Z of Risk-Based Monitoring (RBM): Strategies for the Future during the invitation-only Evolution Summit February 24-26, 2019 in Rancho Mirage, CA.

As the clinical trials industry continually evolves, Linda will discuss how novel strategies must be implemented in an effort to operate efficiently and ultimately accelerate drugs to the market. A more centralized, risk-based approach to site monitoring has presented itself as one viable method of reducing costs. Linda’s topics for discussion include:

  • Implementing a well-designed RBM strategy that enhances, while supporting, traditional monitoring approaches
  • Tools needed to execute the strategy
  • Overcoming challenges and the benefits to be realized

Click here for more information on the 2019 Spring Evolution Summit.


Ask icon

  Ask the Experts

MCC Answers Your Metric Questions
Q: My Central Lab vendor has been trying to convince me to use MCC metrics rather than the metrics we have defined. We have a lot of historical data with our metrics. Why should we use MCC metrics?

Meet The Experts

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




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

A: The table below summarizes the main advantages of the different approaches. There are certainly advantages to using metrics that your company has developed. But there are many more advantages in using MCC standard metrics. Your metrics may have been developed with expertise in your company, but the MCC metrics have been developed in collaboration with many sponsor and vendor companies across the industry. In addition, using the MCC Metrics Development Model helps ensure the standard metrics are all very clearly defined including their purpose, formula, target and recommended additional actions. If you are an MCC member organization, then you have access to a community of people from across the industry who are interested in metrics and their use. Whether or not you are a member organization, there is the “Ask the Expert” facility at the MCC.

It is likely that your vendor(s) is set up to use and report MCC metrics. Using this standard makes it easier for them – making your organization “easier to do business with.” In addition, this means they will be able to provide data on how the metrics with your company compare with those across all companies they work with. This might point to improvement opportunities for your organization which you may otherwise not have been aware of.

MCC Metrics

Company-derived metrics

Metrics developed based on industry knowledge and collaboration Your organization is used to interpreting the metrics
MCC metrics use the MCC Metrics Development Model to ensure high value, well-defined metrics You may have historical data to compare over time
Many vendors have standard MCC metrics and reports pre-programmed (reduced cost)  
Easier for vendor to compare across clients and provide feedback on how working with your company compares with others  
Easier for vendors to use in process improvement efforts – as they are common across clients  
There is a community of other organizations who are interested in metrics and their use who you can tap into with questions or clarifications on the metrics and their use.  

Education icon

  Education

Does Your Staff Know How to Use Metrics Effectively?
Changes in the industry are forcing organizations to do more than just collect and enter data – they have to understand what the data is saying.

To be ICH E6(R2) compliant, organizations need to change the way their trials are conducted and reported, making the need for metric knowledge more important than ever. MCC’s eLearning Education Program is the tool every organization needs to give employees that needed knowledge.

The unique eLearning education program allows professionals to gain a solid metric knowledge foundation with a flexible format that can be customized to meet your needs. The MCC eLearning Education Program:

  • Teaches industry-leading metric understanding
  • Provides a self-study, on-demand learning program to accommodate your busy schedule
  • Accommodates several learning styles
  • Allows you to pause and pick up at a later time
  • Can be easily customized and deployed on your organization’s Learning Management System

Learn more about the entire MCC Education Program and view demos on the following eLearning courses:

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.

 
WCG Market Intelligence & Insights

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