Events

Topic: Events

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.

MCC Breakfast Events: Feasibility/Study Start-Up and Risk Management/KRI

Monday, April 11, 2016

You are invited to attend the MCC Feasibility/Study Start-Up and Risk Management/KRI meetings to be held in May in Princeton, NJ, Durham, NC, and Boston, MA. Please join the MCC staff and distinguished speakers for a complimentary breakfast and informative discussions.

 Session 1: Feasibility and Study Start-Up – What data do you have? What data are you seeking?

Linda Sullivan – President, MCC

Kenneth Getz /Mary Jo Lamberti – Tufts CSDD

Barry Milton – Director, goBalto, Inc.

Session 2: MCC Risk Management Tool and Site KRIs – newly released assets from MCC work groups.

Linda Sullivan – President, MCC

Keith Morgenstern – Director Metrics Programs, MCC

Meeting Logistics

7:45 – 8:15 am     
Check-in and Continental Breakfast

8:15 – 9:45am      Session 1

10:00 – 11:30am     Session 2

Dates and Locations

Thursday,
May 12, 2016

    

Princeton Marriott Forrestal (Fitzgerald Room)

     100 College Road East

     Princeton, NJ

Register here for Princeton, NJ

Tuesday,
May 17, 2016

    

Marriott at Research Triangle Park (Edison Ballroom D)

     4700 Guardian Drive

     Durham, NC

Register here for Durham, NC

Wednesday,
May 18, 2016

    

Metro Meeting Centers – Boston (Winthrop Room)

     101 Federal Street, 4th Floor

     Boston, MA

Register here for Boston, MA

About MCC

MCC—a trusted partner in the clinical trials industry—identifies what to measure and how to assess the critical components of what is changing, and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

MCC eTMF/TMF Metrics Leadership Team Progress Webinar

Tuesday, December 22, 2015

The Metrics Champion Consortium (MCC) held a member only session on 20 November that provided an update on the progress made by the MCC’s eTMF/TMF Metrics Leadership Team. During the session, the MCC outlined the stages of the MCC Metrics Development Process, a proposed basic and advanced Metric Framework that accommodates paper and eTMF processes and a TMF Artifacts Mapping Tool (based on the TMF RM V3).

During the session, the MCC also announced the launch of a new survey where it will ask members for feedback regarding the TMF Critical Success Factors (CSFs) and Key Performance Questions (KPQs) discussed during the webinar.

If you are a MCC member and wish to participate in the guided review of the TMF metrics, log onto the MCC Member Portal to see the list of open surveys which includes, Guided Review of TMF Key Performance Questions. Contact Customer Service for any assistance.

Survey results will be shared with a now-forming MCC TMF Working Group that will make recommendations on the initial set of TMF metrics. You can signup to be part of this working group at the end of the survey.

The MCC also has available the recording of this session for MCC members. This can be found in the Workgroup News section of the TMF Workgroup page on the MCC Member Portal.

Please contact Linda Sullivan at lsullivan@metricschampion.org for additional information.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.

Looking For Clinical Trial Oversight Solutions? Register for MCC’s Special Webinar for Small/Mid-sized Sponsors

Tuesday, November 17, 2015

How Can Small Companies Benefit from Efforts to Standardize? Join Us on Dec 1st to Learn More 

Join us for this complimentary webinar on December 1st, 11am-12 pm EST to learn how your company can benefit from participating in the Metrics Champion Consortium’s small/mid-sized sponsor Community of Practice Group.

Topic:

This webinar will address clinical trial performance management solutions designed for small/mid-sized sponsors, including:

  • Robust performance metric definitions, including performance targets
  • Quality and Risk scoring tools
  • Metric implementation support and education programs
  • Small sponsor Industry surveys

Who Should Attend:

  • Individuals from small/mid-sized sponsors
  • Anyone interested in learning more about the benefits of MCC

This webinar is open to the public. Featured speakers include Laurie Halloran (President and CEO of Halloran Consulting Group) and Linda Sullivan (Co-Founder and President of Metrics Champion Consortium).

CLICK HERE TO REGISTER NOW!

About MCC

MCC—a trusted partner in the clinical trials industry—identifies what to measure and how to assess the critical components of what is changing, and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.