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.
Position papers
10 pages
Data Residency and Cross-Border Transfer in Decentralised Trials
Where clinical data physically travels — and why the device, the connectivity layer and the controller question, not just the cloud, decide it.
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Position papers
9 pages
The End of the Device: Decommissioning, Retention and Disposal in Digital Trials
Recovering, wiping, retaining and disposing of trial devices and the data they hold — the lifecycle stage the assessment forgets.
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Position papers
9 pages
Integrating DHTs with EHRs and Clinical Systems
Why the boundary between the device and the clinical system is the regulated unit — and why provenance must survive the handoff
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Position papers
8 pages
ALCOA+ on the Device: Device-Side Data Integrity in GCP
When a device captures trial data — a handset, a wearable, a home instrument or the gateway that relays them — attribution, time and protection against alteration are decided on the device, and no validated database can decide them later.
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The people who wrote these papers run the assessments. Bring the device and the protocol; fifteen minutes is enough to know whether it matters for your trial.
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