Clinical Trial Risk & Performance Management vSummit Sept. 28th - 30th

7/20/2021

What: 4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit

Sponsored by: Metrics Champion Consortium (MCC), a division of WCG

When: September 28th – 30th, 2021

Where: Virtual Summit (vSummit) is online

Register: HERE

 

Clinical Pathways is presenting and leading discussion groups on two topics:

1) Oversight of Monitoring – Are site issues mitigated? The day in the life of a site QMS and the gap in monitoring.

When: Wednesday, September 29, 2021 from 9:45 AM - 11:15 AM

Facilitators: Charles Sather, BSN, CCRA and Sandra "Sam" Sather, MS, BSN, CCRA, CCRC

2) RBQM Maturity Model – How to manage critical implementation components when they are maturing at a different pace? Small to large sponsor/CRO, implementation adaptability.

When: Thursday, September 30, 2021 from 9:45 AM - 11:15 AM

Facilitator: Sandra "Sam" Sather, MS, BSN, CCRA, CCRC CCRC 

 

MCC Summit Agenda:

Choose from two tracks — 1) Quality-by-Design and Risk-Based Quality Management, and 2) Vendor Oversight — and join the discussion:

  • Quality-by-Design (QbD) and Risk-Based Quality Management (RBQM) Track

    • RBQM Implementation Challenges: Translating Key Risk Indicators (KRI) Descriptions into Actual Measurements

    • Outsourcing Your RBQM Program: Setting Up for Success

    • RBQM in Decentralized Trials

    • RBQM Implementation Challenges: Documenting Your RBQM Process and Decisions

    • Risk-Based Site Monitoring Models

    • Implementing RBQM at Small Sponsors

    • The Central Monitor Says a Risk Threshold has been Breached … Now What?

    • What KRIs are Organizations Using? Is There an Emerging Core Set that You Should Start With?

  • Vendor Oversight Track

    • Determining the Right Metrics to Monitor Sponsor-CRO Collaborations

    • Outsourcing Your RBQM Program: Vendor Oversight

    • Using Metrics to Identify Issues and Drive Improvement Activities

    • How to Use Metrics to Gain Insights About Site Activation and Patient Enrollment

    • Decentralized Trials: How Do You Oversee and Manage New Vendors

Description: Join industry experts to learn how to effectively understand and utilize metrics to enhance performance management related to centralized monitoring, vendor management, and data quality. The vSummit consists of pre-recorded sessions and live discussion groups. For the most effective session, view the pre-recorded session before the live discussion.

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Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 35 years of clinical experience, has a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. SAM has been dual certified by the Association for Clinical Research Professionals (ACRP) for over 15 years as a CCRA and CCRC. She is a current ACRP Fellow, which is awarded to individuals who have made substantial contributions to the Association and the industry at large. She is a frequent speaker at industry conferences and has authored dozens of courses for clinical research training programs in various functional areas. She has multiple training, monitoring and project management experiences of diverse size, and objectives with a variety of global clients. In 2002 she co-founded Clinical Pathways (CP), LLC with Charles "Chuck" Sather.

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Charles “Chuck” Sather’s current focus of consulting is to promote efficiency in remote and on-site Monitoring and Auditing in a balanced, fair and amiable manner. He has over 30 years of clinical experience with a Bachelor of Science Degree in Nursing and has been certified by the Association for Clinical Research Professionals (ACRP) as a CCRA for approximately 15 years. He is a frequent speaker at industry conferences, has authored multiple courses for clinical research training programs in various functional areas and has been an Item Writer on ACRP’s Exam Committee. He specializes in:

  • The remote and on-site monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials

  • Regulatory inspection preparation and post audit Root Cause Analysis, Gap Analysis and CAPA development

  • SOP and monitoring tool development

  • And in compliance and data management auditing.

In 2002 he co-founded Clinical Pathways (CP), LLC with Sandra “SAM” Sather.

- The Clinical Pathways Team 

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