Corsano partners with Leitwert. to connect its wearables to hospital IT systems. The Device Hub enables hospitals to continuously monitor the vital signs of trial participants. It automates the capturing of parameters from any device and monitors data quality in real time. Thereby, researchers can conduct efficient and long-term clinical trials based on Real World Data to validate medical devices, develop conventional and digital treatments and objectify outcomes.
Continuous and reliable data collection is a major challenge in the medical field. Wearable medical devices promise convenient, efficient and long-term clinical trials based on the continuous capturing of biomarkers during every-day life of trial participants. The Real World Data can help to overcome challenges like the increasing burden of chronic diseases with personalized treatments and objective outcomes. Automation reduces patient burden, facilitates decentralized study setups and allows complying with increasing regulatory demands in an economically viable way.
However, this approach comes with its own set of challenges:
- Wearable device manufacturers often build complete platforms and offer end-to-end solutions, which complicates the integrationof systems from different suppliers in existing IT infrastructure and the alignment of workflows for study nurses.
- Participant complianceand correct device handling is hard to control outside the assisted environment of a clinic, which endangers data quality and trial success.
- The various circulating wearable devices need to be managedremotely and participants need technical support – neither is part of today’s clinical research organization’s core expertise and cost structure.
Device Hub can be deployed on premise and provides open interfaces to directly integrate with 3rd party devices, analytics tools and clinical trial platforms. Processing pipelines allow for real time quality assessment of incoming data and the accompanying apps can be customized to reflect the workflows in your trial organization. Our gateway software can be deployed on plug-and-play hardware or integrated in your mobile application – whatever is most convenient for your trial participants.
The Device Hub maintains an immutable audit trail and provides configurable workflows to comply with application specific regulatory requirements like GCP, HIPAA, FDA 21 CFR Part11 or ISO 13485.