News

Topic: News

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.

LEARN MORE

Which Metrics Should I Select? Central Lab Tools Help You Select the Right Metrics

Friday, February 15, 2019

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.

Central Lab tool excerpt

At the work group meeting in February, 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 member portal and clicking here.

Not Member?
Email MCC Membership Director, Terry Holland to learn how your organization can join.

MCC Imaging Metrics and Quality Risk Management Online Meeting to Discuss Key Risk Indicators is February 12

Monday, January 14, 2019

MCC members are invited to an online meeting on February 12, 2019 to learn about the cutting edge work being discussed in the MCC’s Central Lab Metrics Work Group and the opportunity to expand the discussion into the Imaging Metrics Work Group.

This reconvening work group will review the Imaging metric set and explore opportunities to use data from the collection and analysis of imaging scans to provide a signal of risk at individual sites or for the study. Specifically, the new work group will explore the following:

  • Look at the image collection and analysis process from the perspective of Quality Risk Management as defined in ICH E6(R2) section 5.0 and define the process steps of highest risk
  • Review existing metrics and determine which could be used as Key Risk Indicators and whether there are metric gaps for the high risk process steps
  • Update the existing metrics to add information now included in other MCC metric sets such as, what the metric does not tell you, metric level (portfolio, study, site), data elements, advanced/basic metric designation
  • Develop implementation support tools – similar to those already in use with other metrics sets – including:
    • Sponsor/vendor metric selection tool
    • Common issues to metric mapping tool
    • Implementation case studies

The Imaging Work Group will hold one-hour virtual meetings on a monthly basis. This meeting will be of interest to people who manage Imaging Core Lab services, Imaging data and/or quality risk management, including risk management, centralized monitoring and/or risk-based monitoring. Participating in this MCC work group is a great opportunity to share your experience with other clinical trial professionals across the industry and to help shape the industry approach to use of imaging data for quality risk management in the future.

MCC members interested in participating in the Imaging Work Group meeting can click here to register.

MCC Announces: Dr. Jean Mulinde, CDER, FDA Confirmed Speaker at Clinical Trial Risk and Performance Management Summit

Thursday, November 1, 2018

What should clinical research industry stakeholders keep in mind when implementing and managing risk-based quality management programs?

How is the FDA using data to quantify risk to determine where to conduct site inspections?

The Clinical Trial Risk and Performance Management Summit and Dr. Jean Mulinde, Senior Advisor, Division of Clinical Compliance Evaluation, CDER, FDA have the answers.

Come to Princeton Nov. 14 and 15 for the first-ever Metrics Champion Consortium Summit. This will be an exclusive gathering of the top minds in trial performance metrics, spearheaded by MCC Executive Director Linda Sullivan. The keynote speaker will be Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP, clinical trials guru, founder of CenterWatch and an MCC partner. Plan on attending this must-see presentation: Next Gen Benchmarking in Biopharma by Linda Martin, President and Founder, The KMR Group.

The roster of experts will guide attendees through the issues that are top of mind in clinical trials metrics today:

  • How is ICH-E6(R2) changing what needs to be measured? What are global regulators looking for?
  • How do metrics influence behavior? Is it rewarding firefighting or preventing problems? Does staff have the critical thinking skills needed to root out what needs to be changed?
  • Centralized monitoring. How is industry approaching key risk indicators and quality tolerance limits?
  • Getting to the root of the problem. Pros and cons of traditional analytic approaches: Is there a better way?
  • Predictive analytics. The next-level key to success. But how to get there?

The Clinical Trial Risk and Performance Management Summit is interactive. Attendees roll up their sleeves with speakers and fellow attendees as they tackle case studies that will bring clarity to the metrics process—and provide needed answers.

Who Will Benefit:

This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • Clinical Operations/Management/ Research/Development
  • Clinical Outsourcing/Vendor Management/Third-Party Management
  • Clinical/Project Operations
  • Performance Analytics/Management/Reporting
  • Metric Reporting/Visualization
  • Quality Management/Clinical Quality Management
  • Compliance/Clinical Compliance/ Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Risk Assessment
  • Centralized Monitoring/Risk-based Monitoring
  • Good Clinical Practices
  • Clinical Process Optimization
  • Vendor Oversight

Conference Details

Clinical Trial Risk and Performance Management Summit

Presented by Metrics Champion Consortium a Division of CenterWatch
Nov. 14-15, 2018 – Princeton, NJ
http://www.fdanews.com/cwctriskperformancemngmntsummit

Tuition:
Early Bird Pricing: $1,597 (available until Oct. 17, 2018)
Regular Pricing: $1,797 (after Oct. 17, 2018)
Significant team discounts are available.

Easy Ways to Register:
Online: http://www.fdanews.com/cwctriskperformancemngmntsummit
By phone: 888-838-5578 or 703-538-7600

About MCC

Leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. Founded in 2006, MCC is the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. MCC provides the collaborative environment for biopharmaceutical and device sponsors, service providers and sites to improve clinical-trial development through use of MCC standardized performance metrics.