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Clinical trial quality: From supervision to collaboration and beyond
Ann Meeker-O'Connell1, Coleen Glessner2
11 Johnson & Johnson, New Brunswick, NJ, USA.
Abstract:
Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.
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