Events

Topic: Events

DIA Session, “Risk-Based Monitoring: Convergence of Technology, Processes, and People,” MCC Presentation Now Available

Friday, July 28, 2017

MCC Ambassador Keith Dorricott presented on this critical topic at the highly attended session during the annual DIA conference in Chicago in June.

Presenters pictured are Mary Arnould (BMS), Keith Dorricott, Steve Young (CluePoints), during their presentation session at the DIA Annual Meeting.

Keith’s presentation included data from surveys of MCC member organizations and highlighted:

  • Data sources typically used for central monitoring
  • Who carries out the central monitoring function
  • Who is responsible for oversight of central monitoring
  • Different approaches to analysis

Additionally, he discussed different models related to site monitoring staff access to central monitoring data and analytic reports:

  1. Centralized model where there is a gatekeeper to the analytics
  2. Decentralized model where site monitoring staff carry out the analysis

A poll of the audience showed a majority use a hybrid approach with centralized analysis as well as site monitors directly accessing analytic reports.

To download this presentation, click here.

For additional information, please visit the Central Monitoring Work Group Homepage.

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.

Announcing New TMF Metric Toolkit that Improves Inspection Readiness

Wednesday, June 21, 2017

Chicago; June 21, 2017 –

Metrics Champion Consortium (MCC) announced today the release of its Trial Master File Metric Toolkit during a poster session at the Drug Information Association Annual Meeting. “The Importance of Measuring TMF Health for Continuous Inspection Readiness” was presented by Dawn Niccum, inSeption Group (formerly Endocyte); Sholeh Ehdaivand, LMK Clinical Research Consulting; and Keith Dorricott, MCC Ambassador.

“Over the last few years, our members have been investing a great deal of resources in updating and improving their TMF filing processes to meet regulatory expectations,” said MCC President, Linda Sullivan. “We are pleased to release the MCC TMF Basic Metric Toolkit which includes a set of core metrics and supporting tools that enables any sized organization to use the widely-adopted Plan-Do-Check-Act iterative management approach to manage and improve TMF inspection readiness.”

The MCC Trial Master File (TMF) Toolkit provides a comprehensive approach to enable organizations to apply Plan/Do/Check/Act to the TMF management process. Specifically, the following are included in the toolkit:

  • MCC TMF Artifacts Mapping Tool (based on the TMF Reference Model v3)
  • MCC TMF Basic Metric Set (includes metric definitions, performance targets and reporting frequencies)
  • MCC TMF Assessment Tool (includes recommended TMF assessment schedule)
  • MCC TMF Implementation Scenario Guide

The toolkit provides sponsors with the means to update their TMF filing and oversight approaches to align with regulatory expectations. Used together, these tools and metrics reinforce the importance of establishing expectations, measuring actual performance and fixing the problems that arise.

“While most organizations utilize the TMF Reference Model as a starting point, the MCC TMF Metrics Work Group participants recognized the need to expand upon the TMF Reference Model to establish role-specific and milestone-/event-based expectations in order to generate meaningful metrics,” explained Sullivan. “This is where the toolkit’s components help by providing a comprehensive way to measure and help manage the TMF.”

For additional information, please visit the TMF Hompage.

About Metrics Champion Consortium (MCC)

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the crucial components of what is changing and how the industry is responding to address these changes to make improvements. MCC continually brings you new insights into the leading trends within the industry. For more information about MCC metric sets and tools, metric education programs and how you can participate in MCC work groups, please visit http://www.metricschampion.org

Contact:
Linda Sullivan
lsullivan@metricschampion.org
317-622-0266

MCC Central Monitoring WG Meeting January 19 – Complete Questionnaire to Register (Members Only)

Friday, December 9, 2016

Risk-Based Monitoring (RBM) is now a familiar term and common practice within many clinical research organizations.  Central Monitoring is considered a key component of effective RBM, but organizations have been designing and implementing Central Monitoring in unique ways.  
 
MCC would like to gather and share information about the current state of Central Monitoring.  Some of the information we are gathering seeks to answer questions such as:

  • How many organizations are using or considering using a Central Monitoring team?
  • What roles make up your Central Monitoring team?
  • What systems do your Central Monitoring team use?

 
MCC is using an online questionnaire to capture this information. At the end of the questionnaire you will have the option to register for the MCC Central Monitoring working group meeting scheduled for Thursday 19 January where the results of the survey will be shared. If you are unable to attend the meeting, please provide your contact information at the end of the survey in order to receive survey results.
 
There are two questionnaires customized for different types of organizations.

Please click Complete CM Questionnaire for Sponsor / CRO if you most closely identify with a sponsor or CRO organization. 
 
Please click Complete CM Questionnaire for Vendors / Consultants if you most closely identify with an organization that provides products, technology and/or services to Sponsors or CROs. 
 
Both questionnaires consist of 10 questions that will take approximately 3 minutes to complete. Your individual survey responses will be kept confidential.
 
Please forward the link to this survey to any colleagues who are directly involved with Central Monitoring within your organization.  This survey is limited to MCC members only.
 
The survey will close on Wednesday 11 January 2017.   

Please contact Linda Sullivan for additional information.

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.