MCC WG Announcements

Topic: MCC WG Announcements

Announcements

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.

Special Joint Meeting of the MCC Key Risk Indicator and Risk-based Monitoring Work Groups on March 5

Tuesday, February 24, 2015

Please join us on March 5, 2015 at 11a.m. EST for an informational one hour webinar hosted by MCC’s KRI and RBM WG facilitators – Keith Morgenstern of Morningstar Consulting and Tammy Finnigan, COO of Triumph Consultancy Services. The following topics will be discussed:

• UPDATE – MCC Risk Assessment Tool [modifications to the TransCelerate RACT v2]

• Risk-Based Monitoring – Practical Lessons Learned from Implementing RBM programs [SME presentation]

• Looking Ahead – Next steps for the MCC RBM WG

We hope you and your colleagues can join us for this complimentary webinar. Pre-registration is required and is open to MCC members only.

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

Join us for Metrics Champion Consortium’s CAPA Metrics Work Group, 24 February

Thursday, February 19, 2015

In this member’s only session, Co-Work Group (WG) Facilitators Linda Sullivan and Liz Wool will be discussing results from the MCC Clinical CAPA Survey #2.

The purpose of this initiative is to review four to six performance metrics that organizations can use to assess the timeliness, quality and effectiveness of their clinical CAPA process. Utilization of these metrics will enable organizations to track CAPA issue trends, as well as identify possible opportunities for improvement.

Co-WG Facilitators Linda Sullivan and Liz Wool will also oversee the Leadership Committee. The committee is designed to provide guidance regarding the metrics, process map, knowledge management framework and more.

Please contact Linda Sullivan (lsullivan@metricschampion.org) to participate in the Leadership Committee or to join the work group. To become a MCC member, visit www.metricschampion.org or email customerservice@metricschampion.org for more information.