Linda Sullivan To Have a Major Role at Upcoming SCOPE Conference

Monthly Archives: January 2018

Linda Sullivan To Have a Major Role at Upcoming SCOPE Conference

Wednesday, January 24, 2018

MCC Co-Founder & President Linda Sullivan will participate in three sessions during SCOPE February 13-14, 2018 and invites you to connect with her. Linda’s topics include total cost of quality, managing and measuring quality with ICH E6 updates and clinical supply performance metrics. Linda will participate in the following:

February 13, 2018 – 10:50-11:40 AM

The Total Cost of Quality – Finding the Balance between Investing in Quality and the Cost of Fixing Quality Problems.

Panel Discussion – Chair: Linda Sullivan

Track: Implementing RBM – Part 1

February 14, 2018 – 9:20-9:45 AM

How ICH E6 Updates Redefine How We Manage and Measure Quality.

Speaker: Linda Sullivan

Track: Implementing RBM – Part 1

February 14, 2018 – 4:30-4:55pm

Is It Time for the Industry to Develop Consensus-based, Standardized Clinical Supply Performance Metrics?

Speaker: Linda Sullivan

Track: Clinical Supply Management

In addition to connecting with Linda, connect with other MCC Members who will be attending. Look for the “MCC MEMBER,” “MCC SOLUTION PROVIDER” and “MCC AMBASSADOR” signs at their exhibit booths.

To arrange a time to meet with Linda during SCOPE, please contact us.

Update to the TMF Basic Metrics Toolkit Now Available

Tuesday, January 23, 2018

MCC’s TMF Metrics Work Group has updated one of the tools within the TMF Basic Metrics Toolkit, which was launched in June 2017. The TMF Basic Artifacts Mapping Tool has been updated and v2.0 is now available on the MCC Member website.

Version 2.0 of the TMF Basic Artifacts Mapping Tool includes suggested milestones/events by which each artifact should be included in the TMF. This simplifies the process for users of the tool by pre-populating suggested milestones/events rather than leaving it to the user to determine the appropriate milestone or event for every artifact type.

Please log in to the MCC Member website and click on the “Existing Metric Sets” tab to download the most recent version. If others in your organization are using the tool, please let them know there is a new version available.

MCC Conducting Industry Survey about Centralized Monitoring Practices – Take the Survey Today

Wednesday, January 17, 2018

In 2016, MCC conducted an industry survey that examined organizational approaches and e-data sources driving centralized monitoring programs. With the adoption of ICH E6 (R2), MCC is conducting a new survey in order to assess how Centralized Monitoring is being implemented across organizations. MCC is soliciting your feedback about how responsibilities are distributed, the impact on study plans, approaches to KRIs and other methods of assessing data, and whether organizations have experience with regulatory inspections of studies using Centralized Monitoring. Specifically, the survey questions explore the following areas:

  • Project/protocol-level risk assessment practices
  • Definition and purpose of centralized monitoring
  • Centralized monitoring adoption
  • Centralized monitoring sourcing strategies
  • Centralized monitoring roles and responsibilities
  • Documents prepared for each study using centralized monitoring
  • Data sources used in centralized monitoring
  • Data analytic approaches
  • Key risk indicator utilization (number and types)
  • How key risk indicator action levels are established
  • Utilization of quality tolerance limits
  • Experience of regulatory inspections on studies with CM

The survey should take approximately 10 minutes to complete and all survey responses will be kept confidential. A summary of the results will be available to those who complete the survey and provide their contact details.

Please forward this survey to any colleagues who are responsible for the areas covered in the survey.