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:
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.