Organizations are gaining experience using CTTI’s Quality by Design (QbD) recommendations to design and conduct better clinical trials. CTTI today announced four new QbD case studies, adding to its robust QbD toolkit. Three of the case studies are also now featured in CTTI’s recently-announced Building Better Clinical Trials: A Case Study Exchange resource.
The case studies provide an in-depth look at real-word implementation of QbD principles by:
QbD is not a checklist, rather it is a common sense approach in which stakeholders consider: (1) what aspects of a trial are critical to generating reliable data and providing appropriate protection of research participants (“critical to quality” factors); and, (2) what strategies and actions will effectively and efficiently support quality in these critical areas.
These new case studies not only describe the critical-to-quality factors for each trial, and how they were addressed, but also provide tangible strategies and examples for how other organizations can implement such an approach.
This news comes on the heels of CTTI announcing:
Want to be featured on Building Better Clinical Trials: A Case Study Exchange?
If you are part of an organization that has used any of CTTI’s recommendations or tools and would like to be featured on the site, we may be able to include your story.
By sharing your experience, you can showcase your organization’s success while providing helpful information that will benefit other organizations and facilitate collaboration and knowledge sharing across the research community.
Please reach out to Karisa Merrill to learn more.