Resource library
Our regulatory position papers and whitepapers on digital health technologies in clinical trials. Three download without an account; a free account opens the rest after email confirmation and personal approval, usually within one business day. No sales calls attached.
Device360 Brochures
Free
2 pages
DeviceConnect — data interoperability
Data-flow mapping, ALCOA+ metadata standardisation, time-synchronisation controls and AI/ML traceability.
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Position papers
8 pages
Predetermined Change Control Plans (PCCP) for AI/ML in Trial DHTs
Why an evolving on-device model needs a pre-agreed change plan — and why the regulatory timeline is the part most easily misjudged.
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Position papers
9 pages
When the Device Thinks: AI/ML in Trial DHTs and the Stacking of Obligations
How an on-device model adds an AI overlay on top of the device rules — and why the 2028 application date is a trap, not a reprieve.
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