The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Harnessing the Power of Data and Analytics to Enhance Quality
Ann Meeker-O'Connell, MS
Vice President, Global Head, Quality Assurance
IQVIA, 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 : What are 5 reasons you should be using biostatistical data analysis tools when conducting research site audits? Examine the critical importance of using statistical monitoring tools to drive effective clinical trial site audits. Maximize your organizations oversight of global research and assure subject safety and data integrity. Root out falsified and suspect data early in the study life cycle.
Augmenting Clinical Research Site Audits with Statistical Analysis Tools
Gloria Miller, RAC
Associate Director QARC
Premier Research, United States
Leveraging Audit Data and Metrics for Risk Identification and Evaluation
Shehnaz Kairas Vakharia, MSc
ADAMAS Clinical Quality Consulting Pvt Ltd, India
David Donohue, MBA
Head, Quality Data Analytics, Systems, Operations, and Optimum
GlaxoSmithKline, United States