Leading you to Success

Matthew

A journey into effective strategies in drug development.

Episodes

  1. Jul 20

    Quality by Design and Diversity in Clinical Trials

    The intersection of Quality by Design (QbD) and Diversity is the next frontier in clinical trial excellence. Historically, QbD focused on operational efficiency and data integrity, while diversity was treated as a recruitment goal. However, modern research and guidelines like ICH E8(R1) and ICH E6(R2) now view representative enrollment as a Critical-to-Quality (CtQ) factor.  Bumper Music: "Space Jazz" Kevin MacLeod (incompetech.com) Licensed under Creative Commons: By Attribution 4.0 License http://creativecommons.org/licenses/by/4.0/ https://www.praecur.com/

  2. May 12

    The Architecture of Trial Integrity

    In this episode Shelia and Matt discuss using Quality by Design in trial design and implementation. This is a deep dive into the importance of implementing a culture of quality and some of the challenges company's can face with this paradigm shift. We also talk about how regulators are thinking about QbD and Critical to Quality Factors. https://www.praecur.com/

  • 2 Episodes

Ratings & Reviews

About

A journey into effective strategies in drug development.

Information

  • Creator
    Matthew
  • Years Active
    2025 - 2026
  • Episodes
    2
  • Rating
    Clean
  • Copyright
    © 2026 Leading you to Success