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Quantifying the Financial Return on Investment of Risk-Based Quality Management Implementation in Clinical Development.

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第一作者： Abigail,Dirks

第一单位： Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. Abigail.Dirks@tufts.edu.

作者： Abigail,Dirks ^[1] ; Sylviane,de Viron ^[2] ; Kenneth,McFarlane ^[3] ; Kenneth A,Getz ^[4]

作者单位： Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. Abigail.Dirks@tufts.edu. ^[1] Clue Points S.A, Louvain-la-Neuve, Belgium. ^[2] CluePoints Inc, King of Prussia, PA, USA. ^[3] Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. ^[4]

关键词 Centralized monitoring Clinical trial efficiency Expected net present value ICH E6(R3)Oncology drug development Quality by design Return on investment Risk-based quality management Source data verification

DOI 10.1007/s43441-026-01002-1

PMID 42348072

发布时间 2026-07-02

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