Implementing an IoT-based information system for the data recording in a phase I clinical center.

Abstract

Clinical trials are facing many efficiency challenges. The clinical development of a new drug represents a huge investment for pharmaceutical companies, takes several years and demands very high standards of data accuracy and integrity. Amongst other disruptive technologies, the Internet of Things has been cited as capable of transforming the clinical research landscape. Implementing an information system based on this technology should therefore be the first step to drive clinical centers into digitalization. An information system based on connected devices is discussed, as well as suggestions of devices and their connectivity. The general computer infrastructure is also mentioned, including the choice of a cloud-based data management platform and server. The solution is expected to revolutionize the way clinical trials are conducted, significantly increasing the data quality, simplifying processes and saving time, while driving down the costs. For example, the manual data entry of the parameters and the Source Data Verification would become partly irrelevant, as the data are supposed to be directly transferred from the measurement devices to the study database, untouched. The system would also allow the study Sponsor to access to accurate data nearly instantaneously. Such an implementation involves new strategic and marketing opportunities, as well as improving competitiveness and positioning on the clinical trials market. Moreover, with such a project, the human aspect should be approached and a plan of Change Management is therefore proposed, based on the Prosci’s ADKAR model. Furthermore, the compliance with the GDPR is verified and explained. Finally, it should be noted that the solution was designed in order to be potentially applicable to any clinical unit and should be adapted to a center’s specific needs.