Events

Topic: Events

MCC Breakfast Events: Feasibility/Study Start-Up and Risk Management/KRI

Monday, April 11, 2016

You are invited to attend the MCC Feasibility/Study Start-Up and Risk Management/KRI meetings to be held in May in Princeton, NJ, Durham, NC, and Boston, MA. Please join the MCC staff and distinguished speakers for a complimentary breakfast and informative discussions.

 Session 1: Feasibility and Study Start-Up – What data do you have? What data are you seeking?

Linda Sullivan – President, MCC
Kenneth Getz /Mary Jo Lamberti – Tufts CSDD
Barry Milton – Director, goBalto, Inc.

Session 2: MCC Risk Management Tool and Site KRIs – newly released assets from MCC work groups.

Linda Sullivan – President, MCC
Keith Morgenstern – Director Metrics Programs, MCC

Meeting Logistics

7:45 – 8:15 am      Check-in and Continental Breakfast
8:15 – 9:45am      Session 1
10:00 – 11:30am     Session 2

Dates and Locations

Thursday, May 12, 2016
     Princeton Marriott Forrestal (Fitzgerald Room)
     100 College Road East
     Princeton, NJ
Register here for Princeton, NJ

Tuesday, May 17, 2016
     Marriott at Research Triangle Park (Edison Ballroom D)
     4700 Guardian Drive
     Durham, NC
Register here for Durham, NC

Wednesday, May 18, 2016
     Metro Meeting Centers – Boston (Winthrop Room)
     101 Federal Street, 4th Floor
     Boston, MA
Register here for Boston, MA

About MCC
MCC—a trusted partner in the clinical trials industry—identifies what to measure and how to assess the critical components of what is changing, and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

MCC eTMF/TMF Metrics Leadership Team Progress Webinar

Tuesday, December 22, 2015

The Metrics Champion Consortium (MCC) held a member only session on 20 November that provided an update on the progress made by the MCC’s eTMF/TMF Metrics Leadership Team. During the session, the MCC outlined the stages of the MCC Metrics Development Process, a proposed basic and advanced Metric Framework that accommodates paper and eTMF processes and a TMF Artifacts Mapping Tool (based on the TMF RM V3).

During the session, the MCC also announced the launch of a new survey where it will ask members for feedback regarding the TMF Critical Success Factors (CSFs) and Key Performance Questions (KPQs) discussed during the webinar.

If you are a MCC member and wish to participate in the guided review of the TMF metrics, log onto the MCC Member Portal to see the list of open surveys which includes, Guided Review of TMF Key Performance Questions. Contact Customer Service for any assistance.

Survey results will be shared with a now-forming MCC TMF Working Group that will make recommendations on the initial set of TMF metrics. You can signup to be part of this working group at the end of the survey.

The MCC also has available the recording of this session for MCC members. This can be found in the Workgroup News section of the TMF Workgroup page on the MCC Member Portal.

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

To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland.

Looking For Clinical Trial Oversight Solutions? Register for MCC’s Special Webinar for Small/Mid-sized Sponsors

Tuesday, November 17, 2015

How Can Small Companies Benefit from Efforts to Standardize? Join Us on Dec 1st to Learn More 

Join us for this complimentary webinar on December 1st, 11am-12 pm EST to learn how your company can benefit from participating in the Metrics Champion Consortium’s small/mid-sized sponsor Community of Practice Group. Topic: This webinar will address clinical trial performance management solutions designed for small/mid-sized sponsors, including:

  • Robust performance metric definitions, including performance targets
  • Quality and Risk scoring tools
  • Metric implementation support and education programs
  • Small sponsor Industry surveys

Who Should Attend:

  • Individuals from small/mid-sized sponsors
  • Anyone interested in learning more about the benefits of MCC

This webinar is open to the public. Featured speakers include Laurie Halloran (President and CEO of Halloran Consulting Group) and Linda Sullivan (Co-Founder and President of Metrics Champion Consortium).

CLICK HERE TO REGISTER NOW!

About MCC

MCC—a trusted partner in the clinical trials industry—identifies what to measure and how to assess the critical components of what is changing, and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

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’s Linda Sullivan to Speak at ExL’s 6th Annual Clinical Quality Oversight Forum

Tuesday, June 30, 2015

ExL is holding its 6th Annual Clinical Quality Oversight Forum in Philadelphia on Oct. 5-7, 2015. The forum will focus on assessment, optimization, and managing the quality of clinical vendors and sites. Industry experts on clinical operations and quality will share their experiences and guidance.

One of these experts, Linda Sullivan, Co-Founder and President of MCC, will be featured as a panelist as well as lead a session. The panel session, Proven Strategies and Best Practices for Ensuring Vendors and Sites are Inspection Ready will take place at 9:15 a.m. on Wednesday, Oct. 7.

Linda’s session will take place on Track A at 10:45 a.m. on Wednesday, Oct.7. The presentation session, Evaluating the Small/Mid Sponsor Landscape and Benchmarking Your Outsourcing Strategy, QMS Development and Oversight Challenges against Similarly Sized Companies will include results of MCC’s small to mid-sponsor survey and share insights about the quality oversight approaches being deployed by smaller-sized sponsors.

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

For more information on the conference and to register, CLICK HERE.

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

Friday, May 29, 2015

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 to Speak at CHI’s Clinical Trial Oversight Summit June 1-3, 2015

Tuesday, April 28, 2015

The Cambridge Healthtech Institute (CHI) is hosting their 4th Annual Clinical Trial Oversight Summit in Boston, Mass. The summit consists of four conferences held over the span of three days (June 1-3, 2015). Linda Sullivan, Co-Founder and President of MCC, will present on three topics over the course of this three-day summit including: Mastering Clinical Trial Monitoring Conference, June 1 at 8:15am Session Title: “Risk-Based Monitoring Industry Survey Results” This session will share results from a 2014 MCC survey report on risk-based monitoring approaches. Topics in this session include: • Models being adopted and piloted • Where the models are coming from • Why they are being adopted • How metrics are being used as risk signals • How RMB has changed since the 2008 CTTI survey Linda recently published a peer-reviewed article on this subject in Applied Clinical Trials magazine. Read the article here. Vendor Management in Clinical Trials Conference, June 2 at 8:05am Session Title: “Adopting Standardized Time, Quality, and Efficiency Performance Metrics Across Your Vendors” Topics in this session include: • Utilizing metrics to assess your vendor relationships • Metric updates to support quality-by-design approaches • New performance metrics from emerging “e” system vendors (ex. eCOA, eTFM) Clinical Auditing Forum Conference, June 2 at 3:30pm Session Title: “Rethinking CAPA Metrics and TMF Metrics: Are you Measuring the Right Things?” This session will analyze research done by the MCC on standardization of metrics that drive clinical trial quality. Topics in this session include: • How measurement choices influence behavior The first meeting will take place via webinar on May 27, 2015, from 11am-12pm EST. This workgroup is open to all MCC members. • How adopting performance metrics support clinical trial planning • How the right metrics can support your QMS knowledge management program Registration is required. Mention the speaker colleague code “SPK00” when registering online and receive $200 off a commercial conference registration or $100 off an academic, hospital or government affiliated registration. For more information, visit www.clinicaltrialsummit.com.

MCC’s Linda Sullivan to present at MAGI Clinical Research Conference-2015 East

Tuesday, April 21, 2015

Linda Sullivan, Co-Founder and President of MCC, will present on “Clinical Trial Metrics for Sponsors, Sites and CROs: The Good, The Bad, and the Useless” at the MAGI East conference in Arlington, VA, on May 18, 2015, from 2:30pm-3:15pm.

Come to the session to learn more about which metrics are meaningful, and which are not.

MAGI (Model Agreements& Guidelines International) hosts two annual conferences per year, one in the eastern United States in the spring, and one in the western United States in the fall. The MAGI 2015 East Conference will be held in Arlington, VA, from May 17-20. Additional information about the meeting can be found HERE.

Please contact Linda Sullivan at lsullivan@metricschampion.org if you are planning to attend the conference and would like to meet with her at the meeting.

MCC Raleigh-Durham, NC Complimentary Breakfast Meeting on April 17

Wednesday, April 1, 2015

Join the Metrics Champion Consortium (MCC) for a complimentary breakfast meeting and learn how you and your organization can benefit from a MCC membership. If you’re already a member, learn what’s new!

The event will take place from 8:00 AM to 10:30 AM on Friday, April 17, 2015 at the Marriott at Research Triangle Park.

CLICK HERE TO REGISTER NOW

There will be special presentations by Linda B. Sullivan, Co-founder & President of MCC, and Tammy Finnigan, MCC Risk-based Monitoring Work Group Leader, and COO of Triumph Consulting Services.

Discussion topics include: updated standardized performance metrics, quality management systems, new metric sets and much more.

Registration is required for these meetings. Contact customerservice@metricschampion.org for more information.