RBQM 101: Getting Started with Risk-Based Quality Management

Centralized monitoring is more important now than ever before due to the constraints and challenges placed on clinical trials during the global pandemic. Centralized monitoring fits into a comprehensive risk-based quality management (RBQM) strategy. This webinar will focus on making RBQM accessible, providing an overview of how to get started and how users can embed RBQM processes directly into clinical trial management system (CTMS) workflows to improve adoption.

Accessibility is key because companies are still not implementing risk-based quality management a decade after the ICH E6(R2) addendum. This webinar will address many of the common barriers: system and budget requirements, terminology and process uncertainty, and key risk indicator (KRI) development and management.

Perhaps the most significant roadblock preventing organizations from adopting RBQM is that regulatory agencies have not provided clear implementation guidance. This presentation will include a framework and tips for how teams of all sizes can quickly get started.

This webinar will also provide practical expertise on risk-based quality management implementation approaches. First, users need to perform a risk assessment, then continuously monitor and manage the identified risks. From a process perspective, this can take different forms. Companies can leverage collaborative online tools or develop assessments within purpose-built technology like Veeva Vault CTMS to monitor risks.

In addition, RBQM best practices will be discussed. Register for this webinar to hear experts from ARG share the RBQM components they have implemented, how they operationalized them, techniques to address common challenges, and metrics to measure success. The featured speaker from Veeva will explain how companies can take a holistic approach to risk management and the value of risk-based quality management unified with CTMS processes.

Speakers

Erin Farris, Vice-President of Operations, Atlantic Research Group

Erin Farris is Vice-President of Operations at Atlantic Research Group, responsible for overseeing Project Management, Clinical Operations, and Medical Monitoring services. Erin, along with her leadership team, provides the training and infrastructure (tools, systems, processes) necessary for individual contributors to be successful in performing the tasks at hand. Her team is focused on an efficient and streamlined approach to risk-based quality management using robust data analytics to help project teams make informed decisions.

Erin’s clinical research career started at the site level, where she was responsible for managing investigator-initiated and cooperative studies. Always looking to understand how the pieces fit together and how to improve processes led her into project management. Erin holds a BS in Biology with a minor in Chemistry from Virginia Tech.

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Brad Whitlow, Project Director, Atlantic Research Group

Brad Whitlow is Project Director at Atlantic Research Group, responsible for directing and leading global project activities across therapeutic areas, ranging from early development to larger-scale programs. Brad provides operational oversight across multiple clinical trials, ensuring assigned project managers and project teams are meeting ARG and study requirements. Brad’s vision for ARG Project Management is to continue providing improved or new processes to their Project Managers, allowing for organizational flexibility and efficiency for clients. Brad wants sponsors to continue to see ARG as partners rather than vendors.

Brad has over 20 years of experience spanning research hospitals, biopharmaceutical and CRO companies. He began his career in biomedical research, transitioning to CRA, Project Manager and then to his current position as Project Director. Brad has managed numerous phase I to IV clinical trials, including work on BLA submissions and FDA meetings. Brad holds a BS in Biology from MacMurray College.

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Lauren Garson, Senior Director, Clinical Strategy, Veeva Systems

Lauren joined Veeva in 2018 and is a Sr Director in the Vault Clinical Operations Strategy team. She is responsible for Vault eTMF, SSU, CTMS and payments for Enterprise-level customers and is the lead strategist for the TMF Transfer and Risk Based Study Management features in the Clinical Operations Vault. She is passionate about ensuring that the products that customers adopt from Veeva bring them value and help to bring needed treatments to patients sooner.

Prior to Veeva, Lauren spent the majority of her career at Pfizer in the monitoring group working on process enablement and implementing large-scale technology projects.  After leaving Pfizer, she transferred her subject matter expertise to other life science companies through consulting. She has a BA in Human Development and Family Studies from Cornell University.

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