Quality By Design

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Overview

Avoiding errors, collecting data that is fit-for-purpose, and reducing patient burden are just a few of the many benefits of applying Quality by Design (QbD)—an approach that focuses resources on the errors that matter to decision making during a trial.

CTTI has built a suite of resources—including recommendations for monitoringrecommendations for QbD, a principles document, and a QbD toolkit—that outlines how to apply QbD principles in clinical trials. More recently, we created additional resources—a metrics framework, maturity model, implementation guide, and documentation tool—to help organizations and individual trial teams effectively implement a QbD approach for their trials.

Learn how other organizations have used CTTI’s QbD recommendations to design and conduct better clinical trials.

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