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A dimensional warehouse for integrating operational data from clinical trials
Timely, consistent and integrated access to clinical trial data remains one of the pharmaceutical industry’s most pressing needs. As part of a comprehensive clinical data repository, we have developed a data warehouse that can integrate operational data from any source, conform it to a canonical dat...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6446529/ https://www.ncbi.nlm.nih.gov/pubmed/30942863 http://dx.doi.org/10.1093/database/baz039 |
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author | Farnum, Michael A Mohanty, Lalit Ashok, Mathangi Konstant, Paul Ciervo, Joseph Lobanov, Victor S Agrafiotis, Dimitris K |
author_facet | Farnum, Michael A Mohanty, Lalit Ashok, Mathangi Konstant, Paul Ciervo, Joseph Lobanov, Victor S Agrafiotis, Dimitris K |
author_sort | Farnum, Michael A |
collection | PubMed |
description | Timely, consistent and integrated access to clinical trial data remains one of the pharmaceutical industry’s most pressing needs. As part of a comprehensive clinical data repository, we have developed a data warehouse that can integrate operational data from any source, conform it to a canonical data model and make it accessible to study teams in a timely, secure and contextualized manner to support operational oversight, proactive risk management and other analytic and reporting needs. Our solution consists of a dimensional relational data warehouse, a set of extraction, transformation and loading processes to coordinate data ingestion and mapping, a generalizable metrics engine to enable the computation of operational metrics and key performance, quality and risk indicators and a set of graphical user interfaces to facilitate configuration, management and administration. When combined with the appropriate data visualization tools, the warehouse enables convenient access to raw operational data and derived metrics to help track study conduct and performance, identify and mitigate risks, monitor and improve operational processes, manage resource allocation, strengthen investigator and sponsor relationships and other purposes. |
format | Online Article Text |
id | pubmed-6446529 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-64465292019-04-09 A dimensional warehouse for integrating operational data from clinical trials Farnum, Michael A Mohanty, Lalit Ashok, Mathangi Konstant, Paul Ciervo, Joseph Lobanov, Victor S Agrafiotis, Dimitris K Database (Oxford) Original Article Timely, consistent and integrated access to clinical trial data remains one of the pharmaceutical industry’s most pressing needs. As part of a comprehensive clinical data repository, we have developed a data warehouse that can integrate operational data from any source, conform it to a canonical data model and make it accessible to study teams in a timely, secure and contextualized manner to support operational oversight, proactive risk management and other analytic and reporting needs. Our solution consists of a dimensional relational data warehouse, a set of extraction, transformation and loading processes to coordinate data ingestion and mapping, a generalizable metrics engine to enable the computation of operational metrics and key performance, quality and risk indicators and a set of graphical user interfaces to facilitate configuration, management and administration. When combined with the appropriate data visualization tools, the warehouse enables convenient access to raw operational data and derived metrics to help track study conduct and performance, identify and mitigate risks, monitor and improve operational processes, manage resource allocation, strengthen investigator and sponsor relationships and other purposes. Oxford University Press 2019-04-03 /pmc/articles/PMC6446529/ /pubmed/30942863 http://dx.doi.org/10.1093/database/baz039 Text en © The Author(s) 2019. Published by Oxford University Press. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Farnum, Michael A Mohanty, Lalit Ashok, Mathangi Konstant, Paul Ciervo, Joseph Lobanov, Victor S Agrafiotis, Dimitris K A dimensional warehouse for integrating operational data from clinical trials |
title | A dimensional warehouse for integrating operational data from clinical trials |
title_full | A dimensional warehouse for integrating operational data from clinical trials |
title_fullStr | A dimensional warehouse for integrating operational data from clinical trials |
title_full_unstemmed | A dimensional warehouse for integrating operational data from clinical trials |
title_short | A dimensional warehouse for integrating operational data from clinical trials |
title_sort | dimensional warehouse for integrating operational data from clinical trials |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6446529/ https://www.ncbi.nlm.nih.gov/pubmed/30942863 http://dx.doi.org/10.1093/database/baz039 |
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