Events

Topic: Events

MCC 2019 Risk and Performance Management Summit Participants Rate Event as “Best in Class”

Monday, September 23, 2019

More than 100 North American and European-based individuals from large and small biopharma, CROs, risk-based monitoring and consulting organizations participated in the 2019 MCC Risk and Performance Management Summit in Philadelphia, PA on September 4-5.

This year, the Summit focused on five themes:

  • Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution: Keynote speaker Kenneth Getz, Director of Sponsored Programs and Associate Professor, Tufts University; Founder and Board Chair, CISCRP shared insights about the state of the drug development industry and the need for and impact of patient engagement approaches.
  • Metric Program Implementation: Practical approaches and lessons learned from industry veterans
  • Risk-based Quality Management: Emerging practices in the adoption of risk-based quality management, including the impact of ICH-E6(R2) updates, risk management for small sponsors, quality tolerance limits, developing and using key risk indicator libraries and the application of artificial intelligence and machine learning.
  • Risk-based Vendor Oversight: The impact of ICH E6(R2) on vendor oversight, key considerations to developing healthy sponsor/vendor engagement, and using metrics to manage vendor risk and performance.
  • Applying Critical Thinking Skills to Utilize Metrics Effectively: Participants worked in teams to uncover the root cause(s) of issues described in a case study. Each team was provided with a case study packet that included a description of the organization and outsourcing vendors, protocol synopsis, data reports, questions to explore. Teams were able to request additional metric reports and other types of information to help them determine whether there were issues that needed to be addressed.

The Summit format of presentations, panel discussions, audience polling, facilitated breakout group discussions and small group exercises encouraged active participation of all attendees, and fostered the sharing of ideas and collaborative discussions.

“I am pleased that we continue to provide the industry with a safe place for people to learn, meet peers and share ideas. We received very positive feedback from participants confirming that the Summit is a unique experience and the importance of continuing to run the event in the future. Many participants shared that they plan to bring colleagues to the 2020 Summit” stated MCC Executive Director, Linda Sullivan. “We are already exploring the feasibility of starting several new MCC online, interactive groups to provide MCC members with a forum to continue to explore several popular breakout group topics!”.

Risk-based Monitoring Track Chair, Keith Dorricott summarized his experience, “We had some great exchanges of views and ideas amongst real thought leaders in the industry. There was a high level of energy in the room. I found the discussion on use of Artificial Intelligence eye-opening as senior leaders were quoted as expecting critical thinking skills would no longer be in as much need and yet delegates all thought more critical thinking skills will be needed.”

MCC will be hosting the third annual MCC Clinical Trial Risk and Performance Management Summit September 9-10, 2020. Please contact MCC Executive Director Linda Sullivan or MCC Ambassador Keith Dorricott  if there are topics you would like to see included and whether you are interested in participating as a presenter of panelist.

Visit the MCC Risk and Performance Management Summit website to sign up for event updates.

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 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.

DIA Session, “Risk-Based Monitoring: Convergence of Technology, Processes, and People,” MCC Presentation Now Available

Friday, July 28, 2017

MCC Ambassador Keith Dorricott presented on this critical topic at the highly attended session during the annual DIA conference in Chicago in June.

Presenters pictured are Mary Arnould (BMS), Keith Dorricott, Steve Young (CluePoints), during their presentation session at the DIA Annual Meeting.

Keith’s presentation included data from surveys of MCC member organizations and highlighted:

  • Data sources typically used for central monitoring
  • Who carries out the central monitoring function
  • Who is responsible for oversight of central monitoring
  • Different approaches to analysis

Additionally, he discussed different models related to site monitoring staff access to central monitoring data and analytic reports:

  1. Centralized model where there is a gatekeeper to the analytics
  2. Decentralized model where site monitoring staff carry out the analysis

A poll of the audience showed a majority use a hybrid approach with centralized analysis as well as site monitors directly accessing analytic reports.

To download this presentation, click here.

For additional information, please visit the Central Monitoring Work Group Homepage.

To learn more about membership options or to register to become a member of the MCC, please click here or contact Teresa Holland for assistance.

Announcing New TMF Metric Toolkit that Improves Inspection Readiness

Wednesday, June 21, 2017

Chicago; June 21, 2017 –

Metrics Champion Consortium (MCC) announced today the release of its Trial Master File Metric Toolkit during a poster session at the Drug Information Association Annual Meeting. “The Importance of Measuring TMF Health for Continuous Inspection Readiness” was presented by Dawn Niccum, inSeption Group (formerly Endocyte); Sholeh Ehdaivand, LMK Clinical Research Consulting; and Keith Dorricott, MCC Ambassador.

“Over the last few years, our members have been investing a great deal of resources in updating and improving their TMF filing processes to meet regulatory expectations,” said MCC President, Linda Sullivan. “We are pleased to release the MCC TMF Basic Metric Toolkit which includes a set of core metrics and supporting tools that enables any sized organization to use the widely-adopted Plan-Do-Check-Act iterative management approach to manage and improve TMF inspection readiness.”

The MCC Trial Master File (TMF) Toolkit provides a comprehensive approach to enable organizations to apply Plan/Do/Check/Act to the TMF management process. Specifically, the following are included in the toolkit:

  • MCC TMF Artifacts Mapping Tool (based on the TMF Reference Model v3)
  • MCC TMF Basic Metric Set (includes metric definitions, performance targets and reporting frequencies)
  • MCC TMF Assessment Tool (includes recommended TMF assessment schedule)
  • MCC TMF Implementation Scenario Guide

The toolkit provides sponsors with the means to update their TMF filing and oversight approaches to align with regulatory expectations. Used together, these tools and metrics reinforce the importance of establishing expectations, measuring actual performance and fixing the problems that arise.

“While most organizations utilize the TMF Reference Model as a starting point, the MCC TMF Metrics Work Group participants recognized the need to expand upon the TMF Reference Model to establish role-specific and milestone-/event-based expectations in order to generate meaningful metrics,” explained Sullivan. “This is where the toolkit’s components help by providing a comprehensive way to measure and help manage the TMF.”

For additional information, please visit the TMF Hompage.

About Metrics Champion Consortium (MCC)

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the crucial components of what is changing and how the industry is responding to address these changes to make improvements. MCC continually brings you new insights into the leading trends within the industry. For more information about MCC metric sets and tools, metric education programs and how you can participate in MCC work groups, please visit http://www.metricschampion.org

Contact:
Linda Sullivan
lsullivan@metricschampion.org
317-622-0266

MCC Central Monitoring WG Meeting January 19 – Complete Questionnaire to Register (Members Only)

Friday, December 9, 2016

Risk-Based Monitoring (RBM) is now a familiar term and common practice within many clinical research organizations.  Central Monitoring is considered a key component of effective RBM, but organizations have been designing and implementing Central Monitoring in unique ways.  
 
MCC would like to gather and share information about the current state of Central Monitoring.  Some of the information we are gathering seeks to answer questions such as:

  • How many organizations are using or considering using a Central Monitoring team?
  • What roles make up your Central Monitoring team?
  • What systems do your Central Monitoring team use?

 
MCC is using an online questionnaire to capture this information. At the end of the questionnaire you will have the option to register for the MCC Central Monitoring working group meeting scheduled for Thursday 19 January where the results of the survey will be shared. If you are unable to attend the meeting, please provide your contact information at the end of the survey in order to receive survey results.
 
There are two questionnaires customized for different types of organizations.

Please click Complete CM Questionnaire for Sponsor / CRO if you most closely identify with a sponsor or CRO organization. 
 
Please click Complete CM Questionnaire for Vendors / Consultants if you most closely identify with an organization that provides products, technology and/or services to Sponsors or CROs. 
 
Both questionnaires consist of 10 questions that will take approximately 3 minutes to complete. Your individual survey responses will be kept confidential.
 
Please forward the link to this survey to any colleagues who are directly involved with Central Monitoring within your organization.  This survey is limited to MCC members only.
 
The survey will close on Wednesday 11 January 2017.   

Please contact Linda Sullivan for additional information.