QbD Toolkit: Overview, Learn About QbD , Teach Others About QbD, QbD Principles Document, Exploring the CTQ Factors, Workshop Tools, Adopt QbD, How Others are Using QbD, Get Started
QbD Toolkit Resources: Principles Document, CTTI QbD Recommendations, Key Stakeholders, Maturity Model, Metrics Framework, Case Studies
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Organizations are gaining experience and benefits by using CTTI’s QbD recommendations to design and conduct better clinical trials.
Learn about the different strategies to help integrate QbD thinking into your team’s protocol development process, or read the case studies from others who have already implemented QbD into their trials:
- Emphasis on Protocol Design Helps Alexion with Timeline Adherence
- DCRI Streamlines Protocol Using Quality by Design Thinking
- The Medicines Company Developed Nimble Protocols to Scale for Global Trials
- Quality by Design (QbD) Case Study: University of Oxford CTSU
Note: There is no one “right” way to implement QbD and readers are encouraged to explore the ideas presented in this case study with that understanding. In general, however, the likelihood of a successful, quality trial can be dramatically improved through proactive, cross-functional discussions and decision making about: (1) what aspects of a trial are critical to generating reliable data and providing appropriate protection of research participants (“critical to quality” factors, or CTQ factors); and, (2) what strategies and actions will effectively and efficiently support quality in these critical areas. We have structured these case studies as an in-depth look at both.