News

Topic: News

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.

MCC Site Contracting Metric Toolkit v1.0 and Global Start-Up Comparison Models Now Available

Thursday, August 16, 2018

The newly released MCC Site Contracting Metric Toolkit v1.0, including the MCC’s Global Start-Up Comparison Models, is available for MCC members to download from the member portal.

The toolkit includes detailed metric descriptions and Global Start-Up Comparison Models that group countries into five models according to the impact that regulatory and ethic approval processes have on the site contracting process. This first of its kind comparison model provides organizations with the means for establishing realistic site contracting timeline expectations and comparing results of sites located in different regions of the world. Developed by the MCC Site Selection & Start-Up Work Group, the toolkit contains a comprehensive set of metrics to measure and monitor the important process of site contracting.

The toolkit includes:

  • Metric Set – Background & Overview
  • Introductory webinar
  • Process map with metrics
  • Metrics workbook, including 29 basic and advanced metrics, performance targets and Global Start-Up Comparison Models
  • Implementation Guide
  • Metric selection implementation support tools

The metric set was developed in record time during the successful Metric Kaizen event in April. Keith Dorricott, MCC Site Selection & Start-Up Work Group facilitator and MCC Ambassador, and Bartek Jarosz, site contracting Subject Matter Expert, worked with 26 people representing 15 companies during four consecutive weekly meetings this past April to develop the metrics.

“It was a fantastic team effort,” said Keith. “Working with Bartek we were able to quickly develop the first drafts which helped focus the four April meetings on key discussions and decisions.”

The draft metrics were made available for public comment in May.

The work group then reviewed that public feedback and finalized the metric classifications in June, and developed the remaining components of the toolkit in July.

MCC members can download the Site Contracting Metric Toolkit v1.0 by visiting the MCC metrics sets and tools page.

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

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