News & Press

Topic: News & Press

Help Industry Develop Standard Metrics for Site Payments-MCC Site Payments Process Industry Survey

Thursday, April 27, 2017

As an industry, we have a challenge with site payments. Site payment delays have been cited as one of the key concerns by investigators. Data from the Society for Clinical Research Sites (SCRS) says that 66% of sites report having less than three months’ operating cash on hand, and lengthy delays in payment result in high turnover rates among clinical investigators1. The Clinical Trials Transformation Initiative (CTTI) shows as many as 40% of sites drop out of FDA-regulated clinical trials due to lengthy delays in payments2. By standardizing metrics in this important area, the industry will be better able to baseline, compare, manage and improve performance and ultimately increase the available pool of sites for clinical trials.

The Metrics Champion Consortium is conducting this survey as a baseline exercise before developing metrics. We invite industry Sponsor, CRO and Clinical Trial Site Payment Vendors to participate in this 11 question survey. All responses will remain confidential to the MCC – only de-identified data will be shared in the executive summary and final report. Professionals who complete the survey and include their email address will receive an executive summary.

TAKE SURVEY

1SCRS White Paper on Site Payments[http://www.prnewswire.com/news-releases/site-payment-white-paper-released-by-the-society-for-clinical-research-sites-300352486.html]
2CTTI Outsourcing-Pharma.com Article[http://www.outsourcing-pharma.com/Clinical-Development/Payment-tech-automates-reimbursements-to-clinical-trial-sites]

MCC Article Urges Industry to Standardize Data Entry Metric Definition and Use Performance Data to Improve Data Entry Compliance

Wednesday, April 26, 2017

Linda Sullivan, MCC President, and Keith Dorricott, MCC Ambassador - discussed the results of the 2016 MCC Site Data Entry Practices Survey in their article “Importance of Data Entry Timeliness” published by Applied Clinical Trials. The article reveals that organizations consider timely data entry to be very important but face challenges with measuring and monitoring the data input process. A newly released MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies” provides industry’s perspective on the cycle time from subject visit to data entry by investigative sites, and how organizations use the performance data to improve data entry compliance.

About the Survey

MCC conducted the 28 question, web-based survey between June – August 2016. There were 35 respondents primarily from sponsors and Contract Research Organizations (CROs) both large and small. For more information on purchasing this and other MCC Industry Practices Insight Reports, please email Customer Service or visit our Industry Practices Insights Report Page

Read Linda Sullivan and Keith Dorricott’s article on Applied Clinical Trials Online

Performance Metrics: New eLearning Course Allows You to Go Beyond the Basics

Tuesday, April 25, 2017

MCC introduces a new eLearning course, Performance Metrics: Developing Effective Metrics Using a Structured Process that offers industry professionals a deeper understanding of how to select and use performance metrics to support a company's strategic goals.

Using case study examples and easy-to-use worksheets, professionals will learn to use the MCC Metric Development Framework to establish metrics that align with each level of responsibility in your organization and support program goals and objectives. This easy to follow approach includes the following features:
  • Utilizing processes map to identify control points for metrics
  • Establishing critical success factors
  • Prioritizing key performance questions
  • Defining metrics that answer the key performance questions
  • Reporting metric results in formats that facilitate answering the key performance questions

The price of this course is $560* for members and $699 for non-members. There is also accreditation for 2 hours of CEUs accepted by ACRP and SoCRA.

* Discount code needed. For questions please contact Customer Service

Site Data Entry Cycle Time Definitions Vary and Actual Values Exceed Expectations Undermining Risk-based Study Quality Monitoring

Wednesday, April 5, 2017

Boston, MA. April 05, 2017 - Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—announced today a newly published MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies” revealing that organizations consider this to be a very important metric. The report features twenty exhibits highlighting the following key findings:
  • Organizations encourage timely data entry to identify safety signals early and increase data quality.
  • Industry lacks agreement on how to define the “data entry complete” time point – data entry “complete” when a single data point for the visit has been entered into EDC and data entry “complete” when all data for a complete visit have been entered into EDC are most prevalent responses
  • Site data entry cycle time expectations for “single data” time point group not significantly different from “all data” entered group
  • Some organizations cite challenges with measuring data entry cycle time related to EDC system constraints.

“With the adoption of the ICH E6 (R2) Addendum and the increasing focus on risk management in clinical trials, timely data entry by sites following subject visits is becoming more important,” said Linda Sullivan, co-founder and president at the industry group Metrics Champion Consortium, author of the new report. “Delayed data entry can lead to increased risk both to subjects and the trial. This study shines light on a real industry gap that could itself be a significant source of risk unless urgently addressed. It’s time for the industry to come together across the value chain to resolve the definition, use, expectations and continuous improvement of this important cycle time metric.”

MCC conducted the 28 question, web-based survey between June – August 2016. There were 35 respondents primarily from sponsors and Contract Research Organizations (CROs) both large and small. For more information on purchasing the MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies”, please email customerservice@metricschampion.org or visit http://metricschampion.org/sitedataentrystudy/

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 and Canadian Research Organization Alliance Group (N2) Announce Metric Education Collaboration

Tuesday, March 21, 2017

CluePoints
Boston, MA - Metrics Champion Consortium (MCC) and the Canadian-based Network of Networks group (N2) are working together to develop mutually attractive benefits for the two organizations and their members. Through the N2-MCC collaboration, MCC’s eLearning and Metric Master Certification Programs will be available to N2 members at a discounted rate. Participants will gain expertise in the design, implementation and effective use of clinical research performance metrics. eLearning courses include The Elements that Make Metrics Effective, Developing Effective Metrics Using a Structured Process and Effective Metric Visualizations to Gain Valuable Performance Insights. The Metric Master Certification Program allows participants to apply the knowledge they have gained from the eLearning courses to an independent project relevant to their organizations. Certification program participants receive one-on-one guidance from an MCC advisor and upon successfully completing the program receive an MCC Metric Master Certificate.

About N2

The Network of Networks (N2) is a not-for-profit incorporated organization and an alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity. N2 provides a common platform for sharing best practices, resources and research-related content to ensure efficient and high-quality research, integrity of clinical practices and accountability by bringing together trialists and clinical research professionals from across the country. The organization is truly representative of clinical research in Canada and acts as a national voice and advocate on behalf of a broad range of stakeholders that have an impact on the efficiency and quality of clinical trials conducted in Canada.

To learn more about N2, click here to visit their website.

About MCC

The Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—identifies what to measure, 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.

To learn more about the MCC eLearning offerings, click here

What are the best MCC Performance Metrics for assessing Vendor Performance?

Tuesday, February 21, 2017

MCC is launching a Vendor Oversight work group on March 1st to review and revise MCC Performance Metrics for assessing vendor performance. This new work group will focus on reviewing previously defined metrics related to business operations, clinical operations and quality. The group will also consider the impact of ICH E6 (R2) on these metrics, modifying and adding to the MCC Performance Metrics as needed.

Planned outputs for the group include agreeing on the scope of vendor management, identifying Critical Success Factors and Key Performance Questions, and developing basic and advanced sets of MCC Performance Metrics. The meetings will be held the first Wednesday of the month from 10-11am. Work group meetings are open to all MCC members and registration links can be found on the member portal.

To find out more about the Vendor Oversight group, view the work group page by clicking HERE.

MCC President Linda Sullivan shares insights related to ICH-GCP E6(R2) in Clinical Informatics News Article

Friday, February 17, 2017

Linda Sullivan shared her insights on the major updates to the International Guidelines for Clinical Trials in an article entitled “New GCP R2 Guideline Emphasizes Risk Management Through People, Process, And Technology” by Ann Neuer posted in Clinical Informatics News. Linda speaks on how the new update supports organizations moving to tracking and reporting critical data rather than meaningless data in clinical trials. Click here to read the full article.

MCC Special QM Webinar, “How Regulators are Supporting the Quality Management and Risk Based Procedures in ICH GCP E6 (R2)” featuring guest speaker Ann Meeker-O’Connell, Former FDA Director of the Division of GCP Compliance.

Wednesday, February 1, 2017

The International Conference on Harmonisation’s R2 addendum to the ICH E6 Guideline for Good Clinical Practice (GCP) provides direction on a new approach to clinical monitoring and trial management that requires the use of centralized, quality risk management (QRM) throughout a clinical trial. Sponsors and CROs that are adapting to the changes are approaching this in a variety of ways. That leads to the question, what will regulators expect from organizations as they integrate the new guidelines into their SOPs? The presentation on January 11th , open to all MCC members, focused on the processes and behaviors that the FDA and other regulators are promoting through the quality management and risk-based guidance in ICH-E6(R2) section 5.0 Quality Management. This should be of interest to all organizations whether you have already integrated the changes into your practices or are just starting to plan for the integration.

MCC Members can access this and other Subject Matter Expert Webinars by clicking the Member Login link and going to the MCC Initiative Updates section of the Member Homepage. Scroll down and click on the SME Webinars link.

Please contact Linda Sullivan for additional information.

Learn more about membership options and register to become a member of the MCC

For questions about membership options contact MCC Membership Director, Teresa Holland.

Ann Meeker-O’Connell heads Bioresearch Quality and Compliance for Johnson & Johnson’s consumer sector with responsibility for Good Clinical Practice (GCP), Good Laboratory practice (GLP) and Safety Vigilance oversight. Prior to J&J, Ann served as Director of the Division of Good Clinical Practice Compliance at the U.S. Food and Drug Administration (FDA). At the FDA, Ann led Agency initiatives related to innovative models for clinical trial conduct and oversight, advised on clinical trial policy and regulation development, and oversaw FDA’s GCP collaboration with European Medicines Agency (EMA). Ann earned her Bachelor's in Biological Anthropology and Anatomy and a Master of Science in Pharmacology from Duke University in Durham, NC.

MCC Co-Founder & President Linda Sullivan Featured in Applied Clinical Trials’ New eBook on RBM

Wednesday, December 14, 2016

ACT eBook Linda Sullivan’s article “Standardized Metrics for RBM” is now featured in Applied Clinical Trials’ new 5th edition eBook Risk-Based Monitoring in Clinical Trials: A Focus on Quality Risk Assessment, Management and Planning. The article which focuses on the adoption of standardized cost and quality performance metrics to track and predict performance is featured among several other articles by various authorities in the field of clinical trials that together address questions such as:
  • Have the roles of the monitor advanced?
  • How are CRAs accepting the change?
  • How is pharma implementing RBM—is it more remote, centralized or a combination?
  • How important is eSource to RBM?
Download Applied Clinical Trials’ New eBook
Purchase MCC’s New RBM Survey Report

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.