MCC WG Announcements

Topic: MCC WG Announcements

Announcements

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

MCC Small/Mid-Sized Sponsor Group to Discuss Sponsor Oversight Plans on Sept 25th

Wednesday, September 23, 2015

MCC Small/Mid-Sized Sponsor Group held its inaugural meeting on July 25, 2015 – click here for meeting recap. The next meeting will take place on September 25, 2015 at 11AM EST. During this meeting, Sharon Reinhard, President of Clinical Compliance Solutions will lead a discussion about Sponsor Oversight Plans, including:

  • Review the purpose and benefits of a Sponsor Oversight Plan
  • General content of a Sponsor Oversight Plan
  • Review a sample Oversight Plan template and group discussion about content
  • Discuss the internal stakeholder and review process for the plan
  • Maintaining the Oversight Plan as a living document during the trial

To learn more about the MCC Small/Mid-sized Sponsor Community of Practice, click here.

It’s not too late to participate in the MCC Small/Mid Sponsor survey, please take the survey by clicking here. Your responses will be kept confidential. An overview of survey results will be shared with all survey respondents who provide contact information.

Please note that this meeting 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 Terry Holland for assistance.

MCC Clinical Development Sponsor KPI Survey Results to Be Discussed September 30, 2015

Thursday, September 17, 2015

The MCC is hosting a webinar to discuss the results of a recent sponsor survey about Clinical Development KPI utilization on September 30 from 11am-12pm EST.

The KPI survey is closing on September 23rd. If you haven’t taken the survey, please do so HERE. Your 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 meeting will discuss the preliminary results of the survey, including:

• Utilization of Standard KPIs in large vs small/mid-sized sponsor

• Number and types of KPIs used

• Frequency of KIP review

• How KPI results are used

Please note that this meeting 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 sfowler@metricschampion.org for assistance.

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact tholland@metricschampion.org.

MCC Small/Mid-Sized Sponsor Group July 25th Meeting Recording Now Available – Sponsor Oversight Plans to be Discussed Sept 25th

Tuesday, August 4, 2015

During the July 25th meeting, led by Linda Sullivan, Co-Founder and President of MCC, and Sharon Reinhard, President of Clinical Compliance Solutions, the following items were discussed:

  • MCC Small/Mid Sponsor Community of Practice Overview
  • MCC Small/Mid Sponsor Survey Interim Results
  • QMS Sample Tools
  • Next Meeting

If you missed the MCC Small/Mid-Sized Sponsor Group meeting, you can view the meeting here.*

It’s not too late to participate in the MCC Small/Mid Sponsor survey, please take the survey by clicking here. Your responses will be kept confidential. An overview of survey results will be shared with all survey respondents who provide contact information.

The next meeting will take place on September 25, 2015 at 11AM EST. This meeting is open to MCC members only. During this meeting, the Sponsor Oversight Plan concept will be discussed, including

  • Review the purpose and benefits of a Sponsor Oversight Plan 
  • General content of a Sponsor Oversight Plan
  • Review a sample Oversight Plan template and group discussion about content
  • Discuss the internal stakeholder and review process for the plan
  • Maintaining the Oversight Plan as a living document during the trial

To learn more about the MCC Small/Mid-sized Sponsor Community of Practice, click here.

For information on how to join the MCC, please email mccmarketing@metricschampion.org.

*Please note that due to technical difficulties the first several minutes of the recording are missing.

MCC Small/Mid-sized Sponsor Community of Practice Group Meeting Set for July 24

Friday, June 12, 2015

Please join the MCC on Friday, July 24th from 11am-12pm EDT, for the first Small/Mid-sized Sponsor Community of Practice (CoP) Workgroup. This meeting will review findings from the MCC Small/Mid-Size Sponsor Survey, discuss which topics are of the greatest interest to the group, and preview a sample SOP Review certification form to document review of vendors’ SOPs and a key personnel qualification form.

If you haven’t already taken the survey, please do so by clicking HERE.

The survey results will provide insight about current clinical trial oversight and performance management practices and the needs of small and mid-sized sponsors. Summary results will be shared with survey respondents and used by the MCC CoP group to learn about high priority areas of interest.

The MCC Small/Mid-sized Sponsor CoP will hold online meetings on a bi-monthly basis (July, September and November 2015). The group will learn about best practices, create solutions and discuss what has and hasn’t worked well. Potential discussion topics may include: Sponsor Oversight Plan design and related metrics, Vendor Qualifications (e.g. audits, survey/questionnaire, performance measures), performance scorecards, discussions on leading/lagging indicators of quality and performance, risk-based monitoring and inspection readiness in small companies.

This workgroup is open to all MCC members. For more information, please contact Linda Sullivan at lsullivan@metricschampion.org or 317.622.0266 ext 102.