MCC WG Announcements

Topic: MCC WG Announcements

Announcements

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.

TMF Survey – Are You Measuring the Same Metrics as Your Peers?

Friday, May 29, 2015

The Metrics Champion Consortium (MCC) is launching a Metrics Development Working Group to define a standardized set of TMF performance metrics to be used by clinical trial sponsors and CROs to assess the timeliness, quality and effectiveness of their TMF process. 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.

The MCC is conducting a brief survey designed to gather information from sponsor and CRO organizations about their current utilization of eTMF systems and TMF performance metrics.

CLICK HERE to take the survey

The survey is comprised of 10 questions, organized into the following sections:

a. Survey Participant Demographics
b. What You Are Measuring

Your individual survey responses will be kept confidential. An overview of aggregated survey results will be shared with survey respondents [if you provide your contact information] and discussed during an upcoming MCC webinar.

Please contact Linda Sullivan at lsullivan@metricschampion.org for additional information.

Sponsors: Are You Using the Same Clinical Development KPIs as Your Peers?

Monday, May 18, 2015

The MCC invites you to take part in this special 10-15 minute survey. The following survey has been designed to gather information from the Sponsor clinical development (Phase I-IV) community about their use of Key Performance Indicators (KPIs).

Take The Survey Now!

The survey is organized by the following sections: Survey Participant Demographics, Framework of Your Corporate Clinical Development KPIs, What you do with KPI Results and What You Are Measuring.

All survey results will be kept confidential and participants will receive a summary of survey results. Please obtain a recent copy of your organization’s Corporate Clinical Development KRI report for reference while completing the survey.

For more information, contact Linda Sullivan at lsullivan@metricschampion.org.

MCC’s Inaugural TMF Metrics Meeting To Be Held on May 27th

Wednesday, May 13, 2015

The MCC’s first eTMF Performance Metrics Workgroup will take place via webinar on May 27, 2015, from 11am-12pm EST.

During the session, presenters Linda Sullivan (MCC, Co-Founder & President) and Sholeh Ehdaivand (LMK Clinical Research Consulting, President and CEO) will lead a discussion about the following topics:

  • MCC TMF/eTMF Performance Metric Initiative Goals and Scope of Work
  •  MCC Metrics Development Methodology
  • Review of the MCC TMF Process Map (draft) & Key Process Performance Questions
  • Next Steps

This workgroup is open to all MCC members. To join the MCC, CLICK HERE.

For more information about the workgroup, read the previous announcement HERE.

To sign up for the workgroup and register for the meeting, visit the MCC MEMBER HOMEPAGE.

To download the eTMF Slides, CLICK HERE.

For more information, please contact Linda Sullivan at lsullivan@metricschampion.org.

MCC Small & Mid-sized Sponsor Clinical Trial Oversight and Performance Management Survey

Friday, May 1, 2015

The MCC recognizes that clinical research management and operational needs of small and mid-sized pharma are often different than those of large sponsors. We are excited to announce the creation of – a new Small & Mid-sized Sponsor Community of Practice group designed to meet the specific needs of this sector.

Please take a few minutes to complete an online survey designed to gather input about the clinical trial oversight and performance management current practices and needs of small and mid-sized sponsors. Survey results will be provided to all respondents.

CLICK HERE TO TAKE THE SURVEY

Please contact Linda Sullivan (lsullivan@metricschampion.org) for additional information.

MCC is Pleased to Introduce You to the MCC Ambassador Network

Monday, March 30, 2015

How do you find the right consultant for your organization? The MCC is here to help!

The MCC Ambassador Network consists of qualified industry consultants who are ready to assist your organization. These consultants have a minimum of 10 years of experience in clinical research, are familiar with MCC metrics sets and tools, and have successfully completed the MCC Metric Boot Camp Program. Additionally, many are actively involved with MCC initiatives as subject matter experts, work group facilitators, workshop faculty, and more.  Network Ambassadors can assist you with performance metric projects (strategy, change management and implementation) as well functional specific projects such as vendor selection, vendor assessments, risk management, risk-based monitoring, quality management, QA audits, and eTMF implementation.

“Over the years, I have received numerous inquiries from MCC members requesting metric implementation assistance. People are looking for consultants with practical functional area expertise, metric strategy, and implementation knowledge. Building the Ambassador Network has been a long term goal that we are pleased is coming to fruition,” says Linda Sullivan, Co-Founder and President of MCC.

Search the MCC Ambassador Network Database to find the resources you need for your next project.

MCC Launching eTMF Performance Metrics Initiative in April– Sign Up Today!

Sunday, March 1, 2015

The MCC is pleased to announce the launch of the eTMF Performance Metrics Initiative. This initiative will build on the work of the DIA TMF Reference Model Group and benefit from the MCC’s collective “lessons learned” experience of creating, adopting and updating the other MCC metric sets.

Deliverables will include:

• eTMF subject matter expert webinars

• eTMF process map

• Robust performance metric definitions

• eTMF performance metrics white paper

Participation in the initiative is open to all MCC members: leadership-level members are invited to participate in the Leadership Steering Committee; basic-level members can take part in work group-level discussions.

For additional information, please download the eTMF Metric Initiative slides or contact customerservice@metricschampion.org.

MCC Launching ePRO Performance Metrics Initiative April 2015 – Sign Up Today!

The MCC is pleased to announce the launch of the MCC ePRO Performance Metrics Initiative. Based on the success of the MCC Lab, ECG and Imaging Performance Metric Initiatives, MCC members requested that the MCC form a new group to create a similar set of metrics for the growing ePRO service area. This initiative will benefit from the collective “lessons learned” experience of creating, adopting and updating the other MCC metric sets. Deliverables will include:

• ePRO process map

• robust performance metric definitions

• ePRO performance metrics white paper

• ePRO design quality scoring tool [if members decide to create a tool]

Participation in the initiative is open to all MCC members: leadership-level members are invited to participate in the Leadership Steering Committee; basic-level members can take part in work group-level discussions.

For additional information, please download the ePRO Metric Initiative slides or contact customerservice@metricschampion.org.

Eli Lilly to Present on Risk-based Monitoring Data Strategy, March 12th

Wednesday, February 25, 2015

Don’t miss Eli Lilly’s presentation on metrics and data usage to assess protocol-level risk before, during and after a study. This WebEx will be led by Nancy Dynes, Consultant, Global Medical Quality Metrics at Eli Lilly, and discussion topics will include:

• RBM data perspective

• How to use data to prepare for RBM in a trial

• How to use data to monitor the RBM process across trials

Presentation date and time: Thursday, March 12th, at 11 a.m. EST

*Please note: this presentation will not be recorded.

This presentation is open to members only.

Please log on to the MCC Member Portal or email customerservice@metricschampion.org for registration details.