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Harnessing the Power of Data and Analytics to Enhance Quality
Session Chair(s)
Ann Meeker-O'Connell, MS
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, United States
This session will explore multiple ways that quality professionals can take advantage of data generated across their company and turn data into insights to drive quality improvement. Presenters will review how biostatistical analytic tools from risk-based monitoring can be leveraged to improve audit planning and conduct, including a case study to demonstrate the effective use of these tools. The discussion will then turn to leveraging audit data and metrics for risk identification, evaluation, mitigation and effective CAPA. This presentation will draw upon analysis of data from GCP audits conducted globally over three years. Finally, the session will conclude with a presentation on predictive analytics that leveraging a range of information across an R&D organization to yield tangible insights about the risk of quality events in clinical development.
Learning Objective : Assess the range of data sources, information, and tools that could be leveraged by clinical quality organizations; Discuss different approaches for turning data into insights, from simple metrics to advanced analytics.
Speaker(s)
Augmenting Clinical Research Site Audits with Statistical Analysis Tools
Gloria Miller, RAC
ADAMAS Consulting LLC, United States
Consultant
Leveraging Audit Data and Metrics for Risk Identification and Evaluation
Shehnaz Kairas Vakharia, MSc
ADAMAS Clinical Quality Consulting Pvt Ltd, India
Managing Director
Industry Perspective
David Donohue, MBA
GlaxoSmithKline, United States
Head, Quality Systems and Data Analytics
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