News

Topic: News

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.

Linda Martin, President and Founder, KMR Group to Speak at Clinical Trial Risk and Performance Management Summit

Wednesday, October 17, 2018

Technology has made it easier to collect and report all manner of clinical trial performance metrics. But in that sea of data, are companies focusing on what will move their organization forward?

Clinical trial leaders in every biopharma company are struggling with these questions. Some are ahead of others, but few have mastered the art of turning metrics into process perfection.

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.

Linda and Ken and 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?

Linda Martin, President and Founder, KMR Group will present on the Next Gen Benchmarking in Biopharma. Benchmarks have been a key component in effective R&D and clinical trial management across the Industry for decades. Recently, the Industry has embraced more complex and analytical approaches to drive performance improvements. These techniques, built on machine learning, modeling, and advanced statistical approaches move beyond the general benchmarks to develop more sophisticated measures, models, and capabilities. These new approaches unearth a number of optimizations, specifically in country and site selection for clinical trials.

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.

Linda Sullivan and Keith Dorricott to Facilitate Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2) Webinar

Friday, October 5, 2018

Hosted by MCC, the webinar will be on October 18, 2018 from 11 am-12 pm EDT.

Are the scale … complexity … and costs of your clinical trials increasing?

Since the release of the ICH GCP Guidance updates, your answer is most likely — yes.

And, you — like many sponsors and their partners — might have limited experience with risk-based quality management approaches.

During 60 fast-paced minutes Linda and Keith will:

  • Explore new risk-based quality management requirements described in ICH E6(R2) section 5.0
  • Discuss the importance of critical thinking in risk assessment and risk control
  • Explain the meaning of high and low detectability and the relevance to risk prioritization
  • Describe leading practices to improve risk assessment and quality oversight

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 … and it’s FREE.

Click here to register.

For the First Time, MCC Will Host Two-Day Clinical Trial Risk and Performance Management Summit in Princeton, NJ

Technology has made it easier to collect and report all manner of clinical trial performance metrics. But in that sea of data, are you sure you’re focusing on what will move your organization forward? Clinical trial leaders in every biopharma company are struggling with these questions. Some are ahead of others, but few have mastered the art of turning metrics into process perfection. Come to Princeton November 14 and 15, 2018 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 Co-Founder and Executive Director Linda Sullivan. The keynote speaker will be Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP, Founder of CenterWatch and clinical trials guru.

Linda, Ken and a roster of experts will guide you through the issues that are top of mind in clinical trials metrics today:

  • How is ICH-E6(R2) changing what you need to measure? What are global regulators looking for?
  • How do metrics influence behavior? Are you rewarding firefighting or preventing problems?
  • Does your 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 your success. But how do you get there?

The Clinical Trial Risk and Performance Management Summit is interactive. You’ll roll up your sleeves with speakers and fellow attendees as you tackle case studies that will bring clarity to the metrics process — and provide you with the answers you need.

Click here to view the agenda and register.

Updated TMF Metric Toolkit Includes Advanced Metrics and Implementation Support Tools

Friday, August 17, 2018

The newly released comprehensive toolkit provides organizations with the metrics and tools to assess the health of TMFs.

The toolkit includes basic and advanced metrics to assess the timeliness of filing, document quality and TMF completeness. Additionally, the toolkit includes an implementation guide and metric selection tools.

MCC TMF Metric Toolkit v2.0

MCC members can download the MCC TMF Metric Toolkit v2.0 by visiting the MCC Metrics Sets and Tools Page.