News

Topic: News

2019 MCC Champion Award Recipients Announced

Thursday, September 12, 2019

As the Metrics Champion Consortium (MCC) nears the completion of its fourteenth year, the original mission has stayed the same – to provide the clinical development industry with a neutral forum for sponsors and other clinical trial stakeholders to collaboratively define standardized performance metrics and tools that organizations can utilize to oversee and improve clinical trial planning and execution with the intent to drive process improvement. Although many organizations and individuals participate in MCC work groups and drive the adoption of MCC metrics by their organizations, we like to acknowledge the special contributions made by a select group of individuals.

We are pleased to announce this year’s class of MCC Champions – 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 us in congratulating the 2019 award recipients.

2019 MCC Champion Award Recipients

Ed Campanaro, USAMaria Makarovskaya, USADorcas Speight, UK
Volker Hack, GermanyAnn McCabe, USALien Veys, Belgium
Todd Johnson, USAAaron Nolan, USARavin Warnakulasuriya, USA
Nechama Katan, USAHeidi Shea, USA

Click here for more information about the MCC Champions

 

MCC Site Contracting Metric Toolkit Updated

Wednesday, August 28, 2019

The MCC Site Contracting Metric Toolkit has been updated to include the full complement of Metric Selection and Implementation Support Tools in MCC Next Generation Toolkits.

The following metric selection and implementation supports tools were developed to guide organizations through the metric selection process:

  • 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 Member organizations can download the MCC Site Contracting Metrics v1.1 toolkit by logging in to the member portal and visiting the MCC Metric Sets and Tools page.

Learn more about the MCC Site Selection and Start-Up Work Group.

Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.

Vendor Oversight Quality Metrics Toolkit – Now Available to Members

Wednesday, July 24, 2019

The MCC Vendor Oversight Work Group – comprised of 75 individuals representing 33 organizations – worked collaboratively from June 2018 to March 2019 to develop nineteen quality oversight metrics. The work group used the MCC Metric Development Framework to explore:

  • Potential impact of ICH E6 (R2) and how success is defined and the most important performance questions that can be answered with metrics.
  • The most critical questions for the quality aspect of vendor oversight that we want metrics to help answer.
  • Tools that can be used to help select the right metrics and to calculate them.

The metrics are grouped into three categories: CRO oversight, CRO sub-contracted vendor oversight and functional oversight. A series of Key Performance Questions (KPQs) were developed to guide the metric development process.

MCC Member organizations can download the MCC Vendor Oversight Metrics v1.0 toolkit by logging in to the member portal and visiting the MCC Metric Sets and Tools page.

Learn more about the MCC Vendor Oversight Work Group.

Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.

MCC’s Executive Director to Participate in Public Workshop

Monday, July 15, 2019

The FDA is seeking feedback from stakeholders on the challenges, barriers and enablers that might be impacting the adoption of RBM and related opportunities to improve RBM implementation.

This public workshop – “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations”, held under a cooperative agreement with the U.S. Food and Drug Administration, is an opportunity to capture stakeholder input on:

  • The extent to which organizations have implemented risk-based assessment and monitoring, including in conjunction central monitoring approaches
  • Lessons learned from strategies employed to overcome any obstacles to implementation and to continued execution of RBM
  • Enablers that support implementation and execution of risk-based monitoring
  • How stakeholders assess impact of their RBM program
  • Remaining challenges to implementation or execution that need to be addressed

The workshop is being held in Washington DC on July 17. Linda Sullivan, Executive Director WCG-Metrics Champion Consortium, will participate in two sessions:

  • Session 5: Measuring the Impact of Risk-Based Monitoring Approaches
  • Session 6: Synthesis and Next Steps

Visit the MCC Events page for additional information.

MCC Metric Selection Tools Available to Help Organizations Determine Which MCC Metrics to Use

Thursday, June 27, 2019

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 6-minute webinar to learn more!

Not Member?

Email MCC Membership Director, Terry Holland to learn how your organization can join.

Small Sponsor Knowledge Portal Launched to Support Small Sponsor Community of Practice

Tuesday, June 25, 2019

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.

MCC members can access the Knowledge Portal by logging into the member website, clicking on “Meetings and Work Groups” and selecting the MCC Small Sponsor Community of Practice Group.

Not Member?

Email MCC Membership Director, Terry Holland to learn how your organization can join.

MCC’s Linda Sullivan Looks Forward to Connecting With You During DIA

Friday, June 21, 2019

Linda Sullivan, Executive Director, Metrics Champion Consortium will be moderating the session “Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring” on June 25 at 10:30 AM during the 2019 DIA Global Annual Meeting in San Diego. Linda will be joined by presenters Sherry Merrifield, Senior Director, Global Operations Management, Syneos Health; Ann McCabe Director, Process Excellence and Risk Management, Daiichi Sankyo Inc; and Suzanne Lukac Senior Account Director, CluePoints.

Presentations will focus on the following topics:

  • Bridging risk assessment and a centralized, data-driven strategy
  • Links between quality risk management, CAPA and the learning organization
  • Improving risk assessment through post-study evaluation

Interested in meeting with Linda? Please contact Terry Holland, MCC Director of Membership to set up meeting time.

New MCC Central Lab “Next Generation Metric Toolkit” Includes Metric Selection and Implementation Tools

Friday, May 17, 2019

MCC is pleased to announce the introduction of “Next Generation Metric Toolkits” that include significant upgrades, metrics segmented by level (portfolio/study/site), metric selection tools and a metric reporting planning worksheet.

After undergoing an extensive review, the MCC Central Lab Metrics v3.0 toolkit is now available on the member portal. MCC plans to release additional enhanced metric toolkits over the next 6 months. Why are the updates important? These tools solve a major problem for organizations seeking to adopt MCC standardized metrics, namely how to select the right metrics for their program.

  • answer key performance questions (identified by consortium members)
  • manage common issues (identified by consortium members)
  • provide the basic measures all organization should adopt
  • can be reported based on availability of data elements

In addition to the metrics selection tools, a metric reporting planning worksheet has been developed that sponsors/vendors teams or internal teams can use to record which metrics are going to be used, who will report the metrics and how often metric results will be reviewed.

MCC members can download the updated Central Lab Performance Metrics v3.0 by logging into the member website and clicking on the Existing Metrics Sets tab.

 

Not Member?

Email MCC Membership Director, Terry Holland to learn how your organization can join.

New Tool to Link from Issues to Recommended Metrics: We Want Your Input

Thursday, March 14, 2019

The Site Contracting and Trial Master File metrics toolkits include a novel tool to help organizations select the right MCC metrics. There has been great feedback on the tool and we are developing it for other metric sets.

With the tool, you can select the issue(s) that you have with the process (or those you want to guard against) and the tool provides recommended metrics for you to consider implementing. When the metrics were developed, the work group – experts in site contracting from across the industry – provided their input into the typical issues they come across. From this, MCC mapped the most relevant metrics and developed the “Issues to Metrics” tool. It helps organizations select the right metrics to help them improve. We are focused on developing a similar tool for Cardiopulmonary (ABPM, ECG, Spirometry), Data Management & Biostatistics, eCOA, and Imaging.

Are you interested in seeing the typical issues others have in these areas? We would like your input on what the common issues are that you face. We can map these to the existing metrics. Where this feedback highlights metric gaps, we will look at developing additional metrics. You can access the surveys below.

Cardiopulmonary: https://www.surveymonkey.com/r/Cardio_Issues
DM/Bios: https://www.surveymonkey.com/r/DMBios_Issues
eCOA: https://www.surveymonkey.com/r/eCOA_Issues
Imaging: https://www.surveymonkey.com/r/Imaging_Issues

The surveys close on April 10, 2019.

Interested in working with others in the industry on these metrics? If your organization is not already a member, contact MCC Membership Director Terry Holland for more information.

MCC Risk Management Fundamentals eLearning Course 301 is Available – Register Today

Wednesday, February 20, 2019

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.

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