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

Monthly Archives: May 2015

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.

MCC’s Linda Sullivan to speak at DIA’s 51st Annual Meeting

Linda will be presenting on two topics at DIA’s 51st Annual Meeting, being held June 14-18, 2015, in Washington, DC.

On Tuesday, June 16, at 1:30pm, Linda will present on quality metrics as part of the session, “Roadmap to Measuring Clinical Trial Quality,” which will diagnose the issues and suggest a path forward to using quality metrics in clinical trials. This session is part of the Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP) track.

Her second presentation, “The Metrics Evolution: Using Better Metrics to Inform Decision-Making and Streamlining Clinical Trial Operations,” will be held on Wednesday, June 17, from 3:30-5:30pm, during a session on “Optimizing Investigative Site/Country Selection Using Online Feasibility Tools, Big Data, and Disruptive Technologies,” which is part of the Clinical Operations track.

The DIA Annual Meeting is the largest multi-disciplinary event featuring various educational sessions and presentations, exhibitions and networking opportunities for life science professionals.

If you are planning on attending the meeting and would like to set up a time to meet with Linda, please contact her at lsullivan@metricschampion.org.

MCC’s Linda Sullivan invited to join the NIH National Center Advancing Translational Science CTSA Methods and Processes Domain Task Force

Thursday, May 21, 2015

Linda Sullivan has accepted an invitation from the National Institutes of Health (NIH) to become a member of the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Award (CTSA) Methods and Processes Domain Task Force (DTF). Ms. Sullivan was selected for the position because of her expertise in the area, as well as valuable perspective and keen insights and input.

The goals of the NCATS CTSA program are to:

  • Focus on the scientific study of the process of conducting translational science to enable significant advances in translation
  • Contribute to novel methods across the spectrum of translational science, from conceptual to analytical to logistical methods
  • To accelerate research from bench to bedside to public benefit in order to improve the quality, efficiency and impact or research

The CTSA program, administered through NCATS, is one of the NIH’s largest and most important initiatives spanning 62 institutions across the U.S.

To learn more or to congratulate Linda, contact her at lsullivan@metricschampion.org.

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’s Linda Sullivan has published a chapter in the book Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process

Friday, May 1, 2015

Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process, by Peter Schueler and Brendan Buckley is now available to the public on Amazon.com. The newly released book analyzes trends, challenges, and solutions connected with the drug development process. It also looks at simplifying the process and recent changes.

Linda Sullivan, Co-founder and President of Metrics Champion Consortium (MCC), wrote a chapter on “How Quality Performance Metrics Enable Successful Change” detailing information on quality performance metrics, including sections on needs and solutions, and a SWOT analysis, (the strengths, weaknesses, opportunities, and threats in the industry).

Purchase the book

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

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.