Metrics

Topic: Metrics

Accenture Introduces New Analytics Capabilities in the Accenture Life Sciences Cloud for R&D: Collaborates with the Metrics Champion Consortium to develop the Clinical Operations Insights Platform for Improved Visibility into Clinical Trial Performance

Monday, June 26, 2017

MCCACCENTURE

NEW YORK; June 26, 2017 – Accenture (NYSE: ACN) has developed and introduced a new analytics platform to provide real-time insights on the status and performance of clinical trials for the life sciences industry. The platform, known as the Clinical Operations Insights Platform (COIP), is a module of the Accenture Life Sciences Cloud for R&D, an industry platform for running clinical trials that deliver better patient outcomes.

Accenture has joined forces with the Metrics Champion Consortium (MCC) in the development of COIP, using MCC’s industry clinical trial metrics to measure a company’s clinical trial performance. MCC is an open, collaborative organization devoted to the development of standardized metrics to improve clinical trials.

Accenture’s COIP is designed to help life sciences companies leverage descriptive and predictive analytics using operational data to gain real-time insights about the status and performance of a clinical trial. Accenture’s experience has shown that the COIP can help life sciences companies increase the operational efficiency of clinical trials by as much as 30 percent. The platform gives life sciences clinical operations managers greater flexibility to manage clinical trial programs from anywhere, anytime, by consolidating into a single analytics platform internal and external data sources across clinical trial management systems, electronic data capture systems and clinical research organization partners.

“We are excited about our collaboration with MCC and the addition of their clinical operations performance metrics into our Clinical Operations Insights Platform module”, said Kevin Julian, who leads Accenture’s Life Sciences practice in North America “Together we are integrating technology with metrics standards, making it easier for our clients to understand the health of their study portfolio, manage their business more effectively and bring their treatments to patients.”

MCC has also joined the Accenture Life Sciences Cloud Coalition, which includes Eli Lilly, GSK, Merck, Pfizer, and other prominent pharmaceutical companies. As a member of the coalition, MCC will provide input on the use of standardized performance metrics in the Accenture Life Sciences Cloud for R&D. The aim of the Accenture Life Sciences Cloud Coalition is to enable the R&D function, speed up the drug development process while improving quality and cost for the industry.

“We are pleased to build MCC’s standardized metrics into the Accenture Life Sciences Cloud for R&D Clinical Operations Insights Platform and to welcome Accenture as a member of our consortium”, said Linda Sullivan, co-founder, and president of MCC. “Our members are looking for innovative ways to implement and effectively utilize the standardized metric sets and tools developed in our collaborative working groups – having access to MCC standardized performance metrics in the Accenture Life Sciences Cloud for R&D platform is a win-win for current and future users.”

About Accenture

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With more than 411,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com

About Metrics Champion Consortium

MCC is a trusted partner in the clinical trials industry to identify what to measure and assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. We continually bring you new insights into the leading trends within the industry. For more information, please visit www.metricschampion.org.

Contacts:

Teresa Holland
Metrics Champion Consortium
+ 1 317 622 0266 ext. 108
tholland@metricschampion.org

Cam Granstra
Accenture
+1 312 693 5992
cameria.l.granstra@accenture.com

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

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.

Do You Quantify the Cost of Poor Quality at Your Organization?

Monday, February 13, 2017

MCC’s Study Quality Trailblazer Work Group met for their monthly meeting on Wednesday February 8th. The main topic of this meeting was the cost of poor quality. Points of discussion included:

  • Developing strategies to support and successfully implement study quality improvement practices
  • Focusing on adopting pre-study start-up practices to improve Protocol Quality and Risk Management
  • Learning the ‘Formula for Cost of Poor Quality’
  • The tools available to help your organization deal with the cost of poor quality

MCC Study Quality Trailblazer group meets every 2nd Wednesday of the month. Our focus is on adopting pre-study startup practices that improve Protocol Quality and Risk Management and working together to support piloting of quality improvement initiatives. To learn more about the MCC Study Quality Trailblazer Work Group,click here

REMINDER: Please note that this Work Group is open to MCC members only. If you are a MCC member and wish to register, log onto the MCC Member Portal to obtain the registration link or contact Customer Service for assistance.

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.

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