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QbD, Risk-based Quality Management & Quality Improvement

Available white papers:

  • Metric Development Framework: Defining Metrics That Answer Key Performance Questions
  • Risk Assessment & Mitigation Management Tool 2.0: Risk-Based Quality Management Aligned with ICH E6 (R2)
  • Measure the Right Things at the Right Time: Design Key Risk Indicators and Key Performance Indicators that Provide Timely Insights During Study Conduct
  • Measure the Right Things at the Right Time: Use the Cost of Quality Model to Support Quality-by-Design and Quality Management System Investment Decisions
  • Quality-by-Design: Assessing Study, Site and Patient Burden with the Protocol Operational Complexity Scoring Tool
  • Quality-by-Design: Use the Protocol Development Quality Scoring Tool to Improve Protocol Quality


To receive PDF copies of the white papers, complete the form below. Be sure to check your email containing a link to download the files.