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...

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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
Descripción
Sumario: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.

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