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Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example

The world has seen a shift in the ways of working during the Covid-19 pandemic. Routine activities performed at the clinical investigator sites (e.g. on-site audits) that are a part of Quality Assurance (QA) have not been feasible at this time. Analytics has played a huge role in contributing to our...

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Detalles Bibliográficos
Autores principales: Ménard, Timothé, Bowling, Rich, Mehta, Pooja, Koneswarakantha, Björn, Magruder, Eileen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546713/
https://www.ncbi.nlm.nih.gov/pubmed/33073053
http://dx.doi.org/10.1016/j.conctc.2020.100662
Descripción
Sumario:The world has seen a shift in the ways of working during the Covid-19 pandemic. Routine activities performed at the clinical investigator sites (e.g. on-site audits) that are a part of Quality Assurance (QA) have not been feasible at this time. Analytics has played a huge role in contributing to our continued efforts of ensuring quality during the conduct of a clinical trial. Decisions driven through data, now more than ever, heavily contribute to the efficiency of QA activities. In this report, we share the approach we took to conduct QA activities for the COVACTA study (to treat Covid-19 pneumonia) by leveraging analytics.