MCC WG Announcements

Topic: MCC WG Announcements

Announcements

Site Selection and Start-Up Work Group Launches with Public Meeting

Wednesday, October 30, 2019

Development of site start-up metrics and results from a public survey were the main topics during a public meeting that relaunched the MCC Site Selection and Start-Up Work Group. The well-attended meeting had 97 participants representing 35 organizations.

Citing data from the Tufts Center for the Study of Drug Development, Linda Sullivan, MCC Executive Director and Co-Founder, discussed the need for a focus on site start-up metrics. Attendees then reviewed the results from a public survey that sought input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes.

Highlights from the survey included:

  • Suggestions for changes to the high level process map which have been added to the “working version” of the high-level process map
  • Significant issues in the process that were most selected are related to the time taken for site contracting and site selection
  • Most organizations measure high level cycle times; from site selection to activation and from draft contract sent to contract final
  • Most organizations measure the proportion of sites either not enrolling or enrolling only one patient

After plotting the metrics on the high level process map, the discussion moved to how the interactions between regulatory, ethics and site contracting vary by country and site and should provide context to metric values. The MCC Metrics Development Model was described with reference to the Site Contracting Metrics 1.1, which are available for those in member organizations to download.

The next Site Selection and Start-Up Work Group meeting will be on November 5, 2019 and all future meetings will take place on the first Tuesday of the month. These meetings are only open to MCC member organizations. The work group will be using the MCC Metrics Development Framework to develop a comprehensive metric toolkit that includes basic and advanced standardized metrics that answer key performance questions related to this process.

The MCC encourages members to join the work group! The meetings are a pre-collaborative space for you to meet your industry peers, share experience and develop metrics to help our industry.

Members can register for the November 5 meeting by visiting the Site Selection and Start-Up Metrics Work Group page on the MCC member website or contact Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.

How Should You Measure and Assess New Centralized/Remote/Onsite Site Monitoring Programs?

Friday, October 4, 2019

Adoption of ICH E6(R2) Risk-Based Quality Management approaches has brought significant changes to the site monitoring processes. The processes have changed – how do you evaluate and manage these new monitoring approaches?  Do metrics used to oversee “traditional” site monitoring processes still apply? The industry needs come together to develop a new set of standardized metrics that align with the new emerging approaches of risk-based site monitoring. MCC is launching a new work group to develop a comprehensive set of performance metrics in this important area. During the initial info gathering stage, we welcome participation of member and non-member stakeholders through an online survey. Specifically, the survey gather input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. We will provide those who complete the survey with an executive summary recap of the results.

CLICK HERE to complete the survey by 10-Oct-2019.

The MCC work group will convene for an online meeting on 17-Oct-2019 at 10 am EDT. During the meeting, we review survey results and discuss the following aspects related to the process of centralized, remote and site monitoring:

  • What does the high-level process look like?
  • What are the process issues organizations are encountering?
  • What are the important questions that we want metrics to help us answer?

REGISTER NOW – Open to public

For additional information about this new work group, please visit the Centralized and Site Monitoring Metrics work group page.

Metric Development Work Group Launching to Define Site Selection and Study Start-up Process Metrics

Tuesday, September 24, 2019

MCC is launching a metric development work group to define site selection and site study start-up process metrics. In 2018, MCC released the MCC Site Contracting Metric Toolkit v1.0 that includes detailed metric descriptions and Global Start-Up Comparison Models that group countries into five models according to the impact that local regulatory and ethical approval processes have on the site contracting process. This new MCC work group will build upon the foundation established in the site contracting toolkit and examine the overall process of site selection and start-up. Our goal is to collaboratively develop standardized metrics that can be used across industry to monitor, manage and improve the process. During the initial info gathering stage, we welcome participation of member and non-member stakeholders through an online survey. Specifically, the survey will gather input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. We will provide those who complete the survey with an executive summary recap of the results.

CLICK HERE to complete the survey by 25-Sep-2019.

The MCC work group will convene for an online meeting on 1-Oct-2019 at 10 am EDT. During the meeting, we review survey results and discuss the following aspects related to the process of site selection and study start-up:

  • What does the high-level process look like?
  • What are the process issues organizations are encountering?
  • What are the important questions that we want metrics to help us answer?

REGISTER NOW – Open to public

For additional information about this new work group, please visit the Site Selection & Study Start-up work group page.

Help Prioritize Topics for the Small Sponsor Community of Practice Group

Monday, August 5, 2019

The MCC Small Sponsor Community of Practice Group has been established in response to feedback about the unique needs of smaller-sponsor members. The purpose of the new group is to provide members with the opportunity to:

  • Share ideas and practical approaches that work in small sponsor settings
  • Get up-to-date news about MCC Performance Metric Sets and Tools
  • Provide feedback about how MCC can support small sponsors

The MCC has designed a survey to gather input from small sponsors about how they would like to use the Small Sponsor Community of Practice Group and the topics they would like to explore. Survey respondents will receive a summary recap of results. Responses will be kept confidential.

The survey is designed for sponsors, CROs, vendors, and consultants but not for investigative sites. MCC gathers input from sites via other methods.

Learn more about the MCC Small Sponsor Community of Practice Group.

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

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.

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 launches Solution Provider program – TRI will integrate MCC’s RAMMT tool with TRI’s OPRA RBM and QM Platform

Monday, January 18, 2016

mcctri
FOR IMMEDIATE RELEASE

TRI and the MCC announce the integration of the MCC’s Risk Assessment and Mitigation Management Tool (RAMMT) with TRI’s OPRA Risk-Based Monitoring and Quality Management platform.

Following a long standing working relationship between Triumph Research Intelligence (TRI) and the Metrics Champion Consortium (MCC), TRI will now make the IP developed by the MCC’s Risk Management working group available as part of the risk assessment and management module in their OPRA platform. The need for a centralized, easy to use, auditable protocol risk assessment and management capability is becoming increasingly important to companies running clinical trials, especially given the proposed changes to ICH GCP due to be finalized in 2016. The risk assessment and management functionality being developed by TRI will be available as a standalone OPRA module or fully integrated with the risk-based monitoring components, delivering a complete end to end solution. The process of performing a protocol risk assessment and developing resulting quality risk management plans remains a daunting task for many companies. The OPRA solution will ‘hand-hold’ companies through that process, in an easy to use, centrally accessible, cloud based application, and provide the guidance which comes from the MCC’s RAMMT content at the same time. OPRA will also provide that ever important audit trail, creating a CFR21 Part 11 compliant record of who did what in the system, when, and any subsequent changes that might be made during the course of the trial.

“The MCC and its member community have put a huge amount of effort into developing a thorough, robust, yet very usable structure for managing protocol risk, and defining risk management activity as a result.” said Duncan Hall, CEO of TRI. “Taking this information and serving it through the OPRA platform, now means that we are able to make that information available to anyone running a clinical trial, and to provide continuity of process and data, through risk assessment, risk planning, risk management and ultimately risk- based monitoring. With the upcoming changes in ICH GCP, there is going to be a lot of focus on risk assessment and risk management in clinical trials, and we’re poised ideally to support the industry and make sure that companies are able to not only be guided through the risk assessment and management processes, but be able to prove they are doing so. Not only will this be of value to any current study, but it will allow companies to build up a searchable history of risk management activity and continually improve by learning from what they’ve done on previous studies.”

“We are pleased to announce that TRI is the first organization to be part of the new MCC Solution Provider program. Our members are looking for innovative ways to implement and effectively utilize the standardized metric sets and tools developed in our collaborative working groups – the Solution Provider program sets the stage for MCC to work with IT companies interested in integrating MCC IP into their product offerings,” said Linda Sullivan, Co-Founder and President of MCC. “TRI has been an active member of the consortium over the last several years, especially in the Risk-based Monitoring Working Group. The group benefited from their willingness to share insights about their experience of working with sponsors, CROs and regulatory authorities as they developed their RBM product, OPRA. We look forward to working with them in the Solution Provider program.”

For additional information about the MCC’s Risk Assessment and Mitigation Management Tool, download the white paper here.

Additional Information

About Triumph Research Intelligence

Built on the foundation of Triumph’s 14 years of consulting exclusive to the clinical trials industry, TRI was established in 2013 in order to address the growing regulatory need for the industry to be able to provide evidence of quality risk management, quality oversight and decision making traceability during clinical trial execution. TRI’s OPRA platform has been designed from the ground up, specifically for this purpose and provides an accessible, affordable, hosted and fully 21CFR part 11 compliant environment for quality oversight and risk-based monitoring. Understanding that quality oversight and RBM is not just about technology, TRI provides a full suite of RBM specific services for companies wishing to start or improve on their RBM capabilities. These services include risk assessment, training, KRI design, change management and technology implementation.

Our mission is to improve trial efficiency, quality and patient safety through the practical application of our technology and professional services.

For more information, visit www.tritrials.com

About the 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 http://www.metricschampion.org

MCC Contact:

Teresa Holland

Metrics Champion Consortium

+1 (317) 622-0266 ext. 108

tholland@metricschampion.org

MCC Members Learn About electronic Clinical Outcome Assessments (eCOA) and Begin to Define Performance Metric Set

Monday, December 21, 2015

In early 2015, Metrics Champion Consortium (MCC) member organizations – sponsors and electronic Clinical Outcome Assessment (eCOA) vendors – requested that the MCC facilitate the development of a standard set of eCOA performance metrics to include in the growing MCC library of clinical metric sets. They believed that the time was right to establish an initial set of measures since the use of eCOA (sometimes referred to as electronic Patient Reported Outcomes – ePRO) has continued to grow and evolve. This growth is partially due to it being one of several tools that helps support the current emphasis on patient-centered clinical research.

In response, MCC launched the eCOA Performance Metrics Initiative to define a standardized set of eCOA performance metrics to be used by clinical trial sponsors, CROs and eCOA vendors to assess the timeliness, quality and effectiveness of the eCOA setup and data collection services. Utilization of these metrics will enable organizations to understand how well the process is being executed and managed throughout study start-up, conduct and closeout.

During the first phase of metric development process, MCC worked exclusively with the eCOA Leadership Team – comprised of representatives from ten member organizations (sponsors, eCOA vendors, CROs) – to establish the foundation on which to build the metric set. Specifically, they used the MCC Metrics Development Process to develop an eCOA Process Map, define nine eCOA Critical Success Factors (CSFs) and draft 28 Key Performance Questions (KPQs). In the final phase of the development process, MCC members will define a set of metrics that answer the high priority KPQs.

Additionally, members of the Leadership team hosted an eCOA Basics webinar to provide MCC members with an overview of eCOA that included topics such as, Types of eCOA measures, the eCOA Regulatory Landscape, and the Impact on Data Quality and Subject Retention. MCC members are invited to visit the Education and Training section of the MCC Member Portal to view the archived recording of the session [free of charge] as well as additional information about the eCOA Metrics Initiative.

MCC Member Feedback Survey

MCC is conducting a brief survey designed to gather information from MCC Member organizations about the eCOA CSFs and KPQs. If you are a MCC member and wish to participate in the guided review of the eCOA CSFs and KPQs, log onto the MCC Member Portal to see the list of open surveys which includes, MCC Member Guided Review of eCOA/ePRO Key Performance Questions (KPQs). Survey results will be shared with a now-forming MCC eCOA Working Group that will make recommendations on the initial set of eCOA metrics. You can signup to be part of this working group at the end of the survey.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland. MCC Members are invited to contact Customer Service for assistance with establishing user accounts and accessing the MCC Member Portal.

Time Extended for MCC Clinical Development Sponsor KPI Industry Survey

Many Sponsor organizations use Key Performance Indicators (KPIs) to provide visibility into the success of their corporate clinical development strategies. Those same organizations are interested in knowing whether they measure the same KPIs as their peers. To understand whether Sponsors utilize a similar set of KPIs, the MCC has designed a survey to gather information from the Sponsor clinical development (Phase I-IV) community about their use of KPIs. We believe this to be the first survey on the topic of KPIs for the clinical research industry.

The survey launched in Q3 of 2015, but due to recent increased interest in this topic, the survey will remain open through 2016 January.

PRIOR TO STARTING THE SURVEY, please obtain a recent copy of your organization’s Corporate Clinical Development KPI report for reference while completing the survey. To take the survey, please click HERE.

Individual survey responses will be kept confidential and an overview of aggregated survey results will be shared with survey respondents [if you provide your contact information]. This survey takes approximately 10 minutes to complete.

In addition to sharing survey results with participants, the MCC will host a webinar (for MCC members only) in early 2016 to further discuss the analysis of the results. An announcement will be posted prior to that webinar.

If you have any problems with the accessing the survey, please 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 Terry Holland.

Halloran Consulting Group and Metrics Champion Consortium Join Forces

Friday, November 20, 2015

BOSTON, MA – Halloran Consulting Group announces their partnership with the Metrics Champion Consortium (MCC) as they join MCC’s Ambassador Network program.  As a member of the Ambassador Network, Halloran and the Metrics Champion Consortium will collaborate to create the first Community of Practice group for small to mid-size biotech and pharma organizations to access the resources they need to effectively manage their clinical trial metrics.

Considered the gold standard when it comes to standardized performance metrics across the clinical space, MCC is an industry consortium organization that drives clinical data improvements through the collaborative use of performance metrics. They identify what to measure in clinical trials and how to assess the data on a consistently evolving basis. The new MCC Community of Practice for small to mid-sized sponsors provides organizations with the opportunity to have their own forum to share ideas and practical approaches, learn from their peers, and take advantage of the metric sets and tools available to MCC members.

“Metrics Champion Consortium Ambassadors have the metrics framework knowledge and functional expertise to be a key source of support and insight in the community,” says Linda Sullivan, Co-Founder and President of MCC. “Whereas larger companies have profited from wider opportunities for access to expertise, Halloran’s partnership with MCC opens the doors to allow smaller companies the same benefits.”

“Halloran’s experience and the Metrics Champion Consortium’s assets is a natural fit,” says Halloran CEO, Laurie Halloran. “With more than half of our clients in the small to mid-size range, we are uniquely positioned to understand what these companies are missing, what they need to perform better, and to more efficiently develop safe and effective products for patients. Joining the Ambassador program supports Halloran’s goal that smaller sponsor companies have the network and resources to look for people whose expertise they need.”

The creation of a Community of Practice will result in a network that small biopharma companies can use on a regular basis to learn about emerging topics in the industry.  To that end, Halloran and the Metrics Champion Consortium are jointly hosting a webinar on “How Can Small Companies Benefit from Efforts to Standardize?” Taking place at 11am ET on December 1, 2015, this webinar will address clinical trial performance management solutions designed for small/mid-sized sponsors including performance targets, quality and risk scoring tools, implementation support, and education programs. This complimentary webinar is open to MCC members and non-members.

About the 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 metricschampion.org.

MCC Contact:

Teresa Holland

Metrics Champion Consortium

+1 (317) 622-0266 ext. 108

tholland@metricschampion.org

About Halloran Consulting Group

Halloran is a management consulting firm that partners with life science companies to optimize their development. Halloran works with industry organizations of all types, including biotech, pharma, medical device, and service providers, to identify gaps and implement solutions, helping companies achieve excellence in regulatory, quality, and clinical development. Halloran is certified by the Women’s Business Enterprise National Council as a woman-owned business.
For more information, please visit hallorancg.com.

Halloran Contact:

Elizabeth Schaul

Halloran Consulting Group, Inc.

+1 (617) 648-7879

eschaul@hallorancg.com