1. Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
- Author
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Jennings, Donald G., Nordo, Amy, Vattikola, Aruna, and Kjaer, Jesper
- Abstract
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.
- Published
- 2024
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