The device performs a self-wipe of PII data, resets to factory settings, and is ready for the next trial. Security and Compliance: The Core Advantage In an era of increasing cyberattacks on clinical trial data, the iKey Prime Beta 0900 New stands out. The "New" platform introduces Zero Trust Architecture . Each transmission request is re-authenticated. If a device moves outside its designated geo-fence (e.g., a US-based key suddenly attempting to sync from a banned IP address in Eastern Europe), the unit automatically locks down and alerts the data safety officer.
| Feature | iKey Prime 0800 (Legacy) | | | :--- | :--- | :--- | | Wireless Protocol | Bluetooth 4.2 | Bluetooth 5.3 + 900MHz Mesh | | Battery Life | 7 days | 90 days | | Patient Capacity | 1 | 12 | | On-device Storage | 4 GB | 64 GB | | Regulatory Cert | CE, FCC | CE, FCC, MDR Class IIa, UKCA | | Over-the-air updates | Manual only | Fully automatic | ikey prime beta 0900 new
Moreover, the 0900 series is the first portable iKey to pass the audit for clinical hardware, specifically addressing Annex A.8 (Asset Management) and A.13 (Communications Security). Comparing the "New" vs. Legacy iKey Prime Models For organizations debating an upgrade, here is a clear comparison: The device performs a self-wipe of PII data,
Disclaimer: This article is based on pre-release specifications and beta tester feedback. Final production units may vary. Always consult your clinical trial’s regulatory team before deploying new hardware. Each transmission request is re-authenticated
The device aggregates data from a glucose monitor, spirometer, or activity tracker. Using the Beta 0900 algorithm, it normalizes different data formats into a single CDISC ODM XML stream, sending it directly to the sponsor's database.
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