CONFERENCE PRESENTATION · SCDM 2021 Global Conference
RBQM - Every Piece of the Puzzle Matters!
- Session Type: Panel Discussion
- Session Level: Intermediate
Overview
Risk Based Quality Management (RBQM) encompasses all functional areas, and provides a truly holistic evaluation of risks to study endpoints, patient safety, and the study at large. Data management’s piece of the puzzle is to ensure critical data are defined and detectable within EDC so they can be utilized for ongoing endpoint risk analysis – and each functional area in turn has their own piece that is critical to view the whole picture.
As we evaluate endpoints and associated risks we are addressing questions such as: Who is responsible for outlining risks to study quality from a data perspective? Who is managing defined risks? What is the role and goal for each functional area with regards to the data? These questions become even more important if there are functional service provider (FSP) situations or multiple CROs involved.
This session is a follow-up to the 2019 SCDM panel ‘Risked Based Quality Management – It takes a Village!, where we discussed general RBQM concepts and how to get started. As the next stage in the RBQM journey, we will hear from industry experts and learn not only how they have identified their piece of the RBQM puzzle, but how they combined with other functional areas to form a collaborative, cross-functional evaluation of study risks and mitigations – as well as what can happen when the RBQM puzzles is missing critical pieces. We look forward to sharing knowledge and experiences with industry peers while furthering the RBQM discussion.
Please join myself, Brian Barnes (Medidata), Crupa Kurien (Pfizer), Micheal Ferree (Aperio) and Rachel Oakley CMED) as we explore and define the components of RBQM, the roles and responsibilities of RBQM and Centralized monitoring analytics, how beginning with Quality by Design at the protocol development stage can set the trial up for quality analysis and lastly hear the panelist discuss how things are changing from the past to the present and into the future.
What You'll Learn
- Understanding RBQM Principals.
- Understanding the importance of QTLs and KRIs.
- Understanding the pieces and functional area requirements for RBQM.
- Understanding of process development for ongoing review and assessment of QTL, KRI, Centralized Monitoring Reports.
Meet the Presenters
Stacey King
Sr. Director Data Management
Aperio Clinical Outcomes
As the ultimate leader of Aperio’s data management team, Stacey provides oversight and management of Aperio’s data management and EDC programming services and develops top-notch data management teams. Stacey is a dynamic leader with over 20 years of data management experience. She understands that each program offers its own set of challenges, and she is adept at assessing these challenges while providing data management expertise and guidance. Stacey knows that running successful trials hinges on a cohesive team and working in tandem with project management, safety, clinical and the sponsor. When she isn’t training-up the next generation of data management professionals, Stacey enjoys spending time with her family and her sisters, keeping Aperio’s plants alive and thriving and finding new and exciting ways to express her creativity both at home and in the office.
Aperio Clinical Outcomes
Mike Ferree
Director, Clinical Research Analytics
Aperio Clinical Outcomes
Mike Ferree is the Director of Clinical Research Analytics at Aperio Clinical Outcomes. He has over 15 years of experience in clinical research analysis. He has contributed statistical and programming support to over 200 clinical trials in over a dozen therapeutic areas. He has managed and developed, teams and technology for randomization, supply management, data cleaning, safety monitoring, study analysis, and trial metrics. He is passionate about providing essential reporting visualizations and analytics, to identify trends earlier, correct data issues earlier, and provide a better overall picture of the data integrity, compliance, safety, and efficacy of clinical trials.
Aperio Clinical Outcomes
Rachel Oakley
Senior Director
Cmed
Rachel has 19 years clinical research experience, mostly within CRO clinical operations & FSP Management, including line management and responsibility for EU & APAC. Since 2015, Rachel has been an expert in the RBQM space including process implementation and improvement, strategy and centralised monitoring. Rachel’s focus is to set teams up for success to not only complete a robust initial risk assessment and appropriate cross-functional monitoring strategy for a study, but how to interpret the study data and ensure they continue to manage and monitor that study in line with what the study data is telling them.
Cmed
Crupa Kurien
Central Monitor Manager
Pfizer
Crupa Kurien is a Central Monitoring Manager and Risk Based Quality Management expert at Pfizer. She currently serves as the portfolio oversight manager forCentral Monitoring in the COVID19 Vaccine program and played a critical role in Central Monitoring for the Landmark COVID19 Vaccine. Prior to joining the pharmaceutical industry, Crupa was in academia in the preclinical molecular neuroscience space.
Pfizer
Brian Barnes
Sr. Director, Product Development
Medidata
Brian Barnes is a Sr. Director, Product Development of RBQM for Medidata Solutions. Brian has 15 years of experience in the clinical development space and has been specifically supporting RBQM for the past nine years, specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM Working Group and has presented on the topic of RBQM at industry meetings and conferences, and published in journals.
Medidata
Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
Price
SCDM members: $50
Non-members: $175
Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
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