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DIA 2018 Global Annual Meeting


Harnessing the Power of Data and Analytics to Enhance Quality

    Session Chair(s)
      Ann  Meeker-O'Connell, MS

      Ann Meeker-O'Connell, MS

      • Senior Director/ Head, BioResearch Quality and Compliance, Consumer Products
      • Johnson & Johnson, 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.
    Speaker(s)
      Gloria  Miller, RAC

      Augmenting Clinical Research Site Audits with Statistical Analysis Tools

      Gloria Miller, RAC

      • GCP Compliance Manager
      • Esperion Therapeutics, United States
      Shehnaz Kairas Vakharia, MSc

      Leveraging Audit Data and Metrics for Risk Identification and Evaluation

      Shehnaz Kairas Vakharia, MSc

      • Managing Director
      • ADAMAS Clinical Quality Consulting Pvt Ltd, India
      David  Donohue, MBA

      To be determined

      David Donohue, MBA

      • Head, Quality Data Analytics, Systems, Operations, and Optimum
      • GlaxoSmithKline, United States