Clinical trials involving connected combination devices increasingly rely on collecting accurate, trustworthy data - not just in clinical sites, but also in patients’ homes. Standard Bluetooth implementations often introduce friction and risk: pairing requirements hinder usability, especially in unsupervised settings, and typical data flows expose records to mobile platforms, compromising security and traceability.
This talk introduces how Blecon addresses these challenges with a secure Bluetooth-based communication path designed to support clinical trial requirements across care environments. Data is encrypted and signed on the device, authenticated end-to-end, and remains opaque to phones or gateways - ensuring provenance and integrity regardless of where data is captured.
Unlike conventional Bluetooth solutions, Blecon does not require pairing, reducing the burden on patients and caregivers and mitigating common setup issues. Record acknowledgements and application-level tracking help ensure data completeness, while access to trusted network time enables reliable timestamping. Logical and physical software segregation further supports regulatory compliance with FDA 21 CFR Part 11, GCP, and cybersecurity guidance from the FDA and MDCG.
Attendees will learn how this approach improves data quality and reliability in both clinic-based and home-based clinical trial workflows, while reducing integration and compliance risk for Bluetooth-enabled combination products.