Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective

BACKGROUND: The technological complexities and broad operational scope of eSource impede coordinated, inter-organizational action on advancing at-scale solutions. METHODS: We introduce an architectural framework for articulating technological considerations across organizations. The architecture nei...

Descripción completa

Detalles Bibliográficos
Autores principales: Jennings, Donald G., Nordo, Amy, Vattikola, Aruna, Kjaer, Jesper
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458892/
https://www.ncbi.nlm.nih.gov/pubmed/32865798
http://dx.doi.org/10.1007/s43441-020-00132-4
_version_ 1783576286131650560
author Jennings, Donald G.
Nordo, Amy
Vattikola, Aruna
Kjaer, Jesper
author_facet Jennings, Donald G.
Nordo, Amy
Vattikola, Aruna
Kjaer, Jesper
author_sort Jennings, Donald G.
collection PubMed
description BACKGROUND: The technological complexities and broad operational scope of eSource impede coordinated, inter-organizational action on advancing at-scale solutions. METHODS: We introduce an architectural framework for articulating technological considerations across organizations. The architecture neither implies nor endorses solution implementations; rather, it proposes solution functionality based upon principles and good clinical practices. RESULTS: Key technology considerations include patterns of anticipated use, implications to the current state of clinical trial operations, and the need for new technologies (i.e., IoT, Big Data, Predictive Analytics). CONCLUSION: Technology considerations drive implications beyond technology—influencing regulatory, process, and ethical realms of clinical research. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s43441-020-00132-4) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-7458892
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-74588922020-09-04 Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective Jennings, Donald G. Nordo, Amy Vattikola, Aruna Kjaer, Jesper Ther Innov Regul Sci Original Articles BACKGROUND: The technological complexities and broad operational scope of eSource impede coordinated, inter-organizational action on advancing at-scale solutions. METHODS: We introduce an architectural framework for articulating technological considerations across organizations. The architecture neither implies nor endorses solution implementations; rather, it proposes solution functionality based upon principles and good clinical practices. RESULTS: Key technology considerations include patterns of anticipated use, implications to the current state of clinical trial operations, and the need for new technologies (i.e., IoT, Big Data, Predictive Analytics). CONCLUSION: Technology considerations drive implications beyond technology—influencing regulatory, process, and ethical realms of clinical research. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s43441-020-00132-4) contains supplementary material, which is available to authorized users. Springer International Publishing 2020-03-11 2020 /pmc/articles/PMC7458892/ /pubmed/32865798 http://dx.doi.org/10.1007/s43441-020-00132-4 Text en © TransCelerate Biopharma Inc. 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Articles
Jennings, Donald G.
Nordo, Amy
Vattikola, Aruna
Kjaer, Jesper
Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
title Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
title_full Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
title_fullStr Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
title_full_unstemmed Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
title_short Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
title_sort technology considerations for enabling esource in clinical research: industry perspective
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458892/
https://www.ncbi.nlm.nih.gov/pubmed/32865798
http://dx.doi.org/10.1007/s43441-020-00132-4
work_keys_str_mv AT jenningsdonaldg technologyconsiderationsforenablingesourceinclinicalresearchindustryperspective
AT nordoamy technologyconsiderationsforenablingesourceinclinicalresearchindustryperspective
AT vattikolaaruna technologyconsiderationsforenablingesourceinclinicalresearchindustryperspective
AT kjaerjesper technologyconsiderationsforenablingesourceinclinicalresearchindustryperspective

Ejemplares similares