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Experience Conducting Studies with Risk Based Monitoring Strategies

Nycole Olivo
Wednesday, July 9, 2014
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Chapters

  • Introduction
  • Disclaimer
  • Planning and Implementing RBM Strategies is a Complex Process
  • Complex Planning and Continuous Assessment
  • RBM Planning and Continuous Assessment
  • Quality is Enhanced by RBM
  • Inspection readiness
  • Investigator Portal
  • Investigator Portal Ensures Training Compliance
  • Investigator Portal Reduces Protocol Deviations
  • Quality and Efficiency Gains Through Risk Based Monitoring Plans
  • Analytics Platform Aggregates Data for Real Time Access
  • Methodology Developed to Detect Risk Through Central Monitoring
  • Medical Safety Signal Detection Through Central Monitoring
  • Site Quality Signal Detection Through Central Monitoring
  • Quality and Risk Reviews Maintain Continuous and Iterative Oversight
  • Process to Identify Risks and Mitigate Errors
  • Case Study 1
  • Case Study 2
  • Case Study 3
  • Case Study 4
  • Key Elements for Delivering Quality Studies Using RBM Strategies
  • Thank You
 

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