MCC WG Announcements

Topic: MCC WG Announcements

Announcements

New Forum on Navigating Clinical Trial Operational Challenges Amid COVID-19 Crisis

Friday, April 3, 2020

Metrics Champion Consortium Unveils New Forum to Foster Dialogue on Navigating Clinical Trial Operational Challenges Amid COVID-19 Crisis

Virtual Roundtable Brings Together Industry Stakeholders for Weekly Discussions on How to Measure Risk and Study Performance as Coronavirus Pandemic Evolves

Falls Church, VA – April 3, 2020 – Metrics Champion Consortium (MCC), an industry organization dedicated to improving clinical trials via the development of standardized performance metrics, today announced the launch of a new forum designed to spur discourse on the impact of the coronavirus outbreak on clinical trials and how to tackle operational challenges associated with the ever-evolving pandemic. The weekly, virtual series – the MCC COVID-19 Community of Practice – connects MCC members, representing more than 80 organizations across the global life sciences ecosystem, and provides them with opportunities to share knowledge and collectively think about how to proactively address common industry concerns around risks to trial integrity and benchmarking study performance amid the COVID-19 crisis.

Founded in 2006, MCC is part of WCG’s Study Planning and Site Optimization Division. From biopharmaceutical and medical device trial sponsors to clinical research organizations (CROs), research sites and technology service providers, member organizations utilize MCC’s network to collaborate through working groups focused on addressing shared challenges and opportunities. In light of the COVID-19 pandemic and recent guidance from regulatory bodies on conducting clinical trials, MCC is leveraging its platform to bring together a diverse, global network of clinical research stakeholders to discuss how they are coping with disruptions to study operations as a result of quarantines, site closures, travel limitations, interruptions in the supply chain for the investigational product and infection of site personnel and trial participants, among other ongoing developments. A document summarizing the topics discussed as well as links to relevant consortium resources and regulatory guidance documents are posted in the consortium’s COVID-19 knowledge portal.

“The fallout from the spread of COVID-19 infections will continue to have major implications for clinical trial operations, and we’re committed to doing our part to support our community in navigating through unchartered territory,” said Linda Sullivan, executive director of MCC. “In bringing together MCC members for timely discussions and to regularly compare notes, our goal is to create a forum that drives the knowledge sharing and collaborative thinking that will help to meaningfully address common challenges and offer practical, actionable solutions.”

Donald A. Deieso, PhD, Executive Chairman and CEO of WCG, added: “Collaboration across the clinical trial ecosystem and healthcare more broadly has never been more critical. With the coronavirus pandemic growing rapidly as each day passes, we know that we are all in this together and must find our way through a devastating global health crisis by collaborating and supporting each other. Leveraging its unmatched benchmarking capabilities and insights, MCC is making it possible for the industry to think through needed new metrics and their implications, while working together to determine how to consistently measure performance in an evolving clinical trial landscape.”

Weekly COVID-19 Community of Practice discussions will explore top-of-mind questions on virtual patient visits, risk management and control, centralized monitoring, protocol deviations and amendments, and informed consent form amendments, as well as other topics suggested by members. MCC resources, including a web-based knowledge portal and LinkedIn Group, will also be available to members so that they can share challenges, questions and learnings in real time.

To learn more about MCC membership, please contact Teresa Holland, Membership Director at tholland@metricschampion.org or 1-317-622-0266.

About Metrics Champion Consortium
MCC is the leading industry consortium that brings clinical research stakeholders together, including sponsors, CROs, partners and investigational sites, to collaboratively develop standardized performance metrics and associated tools that help organizations oversee, manage and optimize clinical trial execution.  For more information, please visit www.metricschampion.org.

About WCG
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two divisions – the industry’s first central IRB – WIRB-Copernicus IRB, and first clinical services organization (CSO) – WCG enables biopharmaceutical companies, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protection. For more information, please visit www.wcgclinical.com  or follow us on Twitter @WCGClinical or LinkedIn.

Media Contacts:
MCC: Linda B. Sullivan
317-622-0266
lsullivan@metricschampion.org

WCG: Amy Hutnik
609-250-7654
ahutnik@wcgclinical.com

Public Invited to Compliance & CAPA Community of Practice Launch

Tuesday, February 11, 2020

The MCC Compliance & CAPA Community of Practice will launch with an online meeting 10-March-2020 at 11 am EDT.  This initial meeting of the Community of Practice will be open to the public.

REGISTER HEREOpen to Public

MCC Communities of Practice are about members helping members.  MCC hosts these online meetings and associated LinkedIn Groups for members to learn from each other by sharing case studies, discussing challenges and developing possible solutions.  The online meetings will be every two months with topics chosen by the members of the work group.  Each meeting will include a presentation and opportunity for discussion and Q&A.  Anyone from MCC member organizations can attend any of the Community of Practice meetings – just to listen, to discuss, or even to present on a topic.

Topic for the Compliance & CAPA launch meeting:

“Effective Root Cause Analysis”
Sandra SAM Sather – Vice President at Clinical Pathways
Dawn Niccum – Senior Director, QA & Compliance at inSeption Group

Subsequent meetings will be for those from MCC member organizations only.  Topics to include:

  • Categorization of issue / findings and trending
  • Effectiveness Checks – theory and practice

The Community of Practice will focus on the challenges and opportunities for compliance and CAPA processes discussing a range of topics led by members.

For additional information about this new work group, please visit the MCC Compliance & CAPA Community of Practice page.

Protocol Complexity Case Study to be Presented at January Study Quality Trailblazer Meeting

Wednesday, December 18, 2019

Dr. Frank M. Berger, Head of Analytics, Global Clinical Operations at Boehringer Ingelheim, will present “Case Study – Protocol Complexity” during the January 23, 2020 Study Quality Trailblazer meeting at 10AM EST.

Dr. Berger will cover the following topics:

  • What is complexity?
  • Trial complexity and protocol complexity
  • Common beliefs around trial complexity
  • Different perspectives
  • How to measure trial /protocol complexity
  • Call to action: Let’s collaborate!

MCC members can register for the January 23 meeting by visiting the Study Quality Trailblazer Work Group page on the MCC member website.  Contact Lara Knitter, MCC Customer Service & Product Support for assistance.

Learn more about the Study Quality Trailblazer Best Practice Community.

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

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