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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Main Authors: Timothé Ménard, Rich Bowling, Pooja Mehta, Björn Koneswarakantha, Eileen Magruder
Format: Article
Language:English
Published: Elsevier 2020-12-01
Series:Contemporary Clinical Trials Communications
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865420301460
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spelling doaj-a2ec4840d7494661813c80b935c43d332020-12-23T05:03:27ZengElsevierContemporary Clinical Trials Communications2451-86542020-12-0120100662Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study exampleTimothé Ménard0Rich Bowling1Pooja Mehta2Björn Koneswarakantha3Eileen Magruder4F.Hoffmann-La Roche AG, Basel, Switzerland; Corresponding author. F. Hoffmann-La Roche, CH-4070 Basel, Switzerland.Genentech Inc, A Member of the Roche Group, South San Francisco, USAGenentech Inc, A Member of the Roche Group, South San Francisco, USAF.Hoffmann-La Roche AG, Basel, SwitzerlandGenentech Inc, A Member of the Roche Group, South San Francisco, USAThe 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.http://www.sciencedirect.com/science/article/pii/S2451865420301460Quality AssuranceClinical TrialsAnalyticsAuditClinical Data Monitoring
collection DOAJ
language English
format Article
sources DOAJ
author Timothé Ménard
Rich Bowling
Pooja Mehta
Björn Koneswarakantha
Eileen Magruder
spellingShingle Timothé Ménard
Rich Bowling
Pooja Mehta
Björn Koneswarakantha
Eileen Magruder
Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example
Contemporary Clinical Trials Communications
Quality Assurance
Clinical Trials
Analytics
Audit
Clinical Data Monitoring
author_facet Timothé Ménard
Rich Bowling
Pooja Mehta
Björn Koneswarakantha
Eileen Magruder
author_sort Timothé Ménard
title Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example
title_short Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example
title_full Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example
title_fullStr Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example
title_full_unstemmed Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example
title_sort leveraging analytics to assure quality during the covid-19 pandemic - the covacta clinical study example
publisher Elsevier
series Contemporary Clinical Trials Communications
issn 2451-8654
publishDate 2020-12-01
description 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.
topic Quality Assurance
Clinical Trials
Analytics
Audit
Clinical Data Monitoring
url http://www.sciencedirect.com/science/article/pii/S2451865420301460
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