Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?

BACKGROUND: The increasing number of clinical trials and their complexity make it challenging to detect and identify clinical quality issues timely. Despite extensive sponsor audit programs and monitoring activities, issues related to data integrity, safety, sponsor oversight and patient consent hav...

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Detalles Bibliográficos
Autores principales: Koneswarakantha, Björn, Ménard, Timothé, Rolo, Donato, Barmaz, Yves, Bowling, Rich
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458946/
https://www.ncbi.nlm.nih.gov/pubmed/32865805
http://dx.doi.org/10.1007/s43441-020-00147-x

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458946/
https://www.ncbi.nlm.nih.gov/pubmed/32865805
http://dx.doi.org/10.1007/s43441-020-00147-x

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