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
Free
10 pages
The Smartphone in Digital Endpoints
Indispensable conduit, immature instrument — the phone’s role in capturing, processing and submitting digital endpoint data
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Position papers
Free
6 pages
What the Trial Needs From the Handset Maker
A companion reading from the phone manufacturer / OEM (original equipment manufacturer) seat — what the trial needs from you, and why none of it is your obligation
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Position papers
Free
6 pages
Your Device, and the System It Joins
A companion reading from the wearable / biosensor manufacturer seat — your own obligations, and the system the bridge creates
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Position papers
10 pages
Labelling, UDI and Supply-Chain Transparency for Trial DHTs
Why the labelled article is the software, the supplied unit or the sensor — never the phone, tablet or gateway that carries it — and why BYOD makes identification harder, not exempt
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Position papers
7 pages
Sensor-Based DHTs Cleared by FDA: A Landscape Annex
A structured view of the sensor-based digital health technologies FDA has authorised — what they measure, who makes them, how they connect, and what the list does not tell a sponsor
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Position papers
10 pages
Validating Sensor-Derived Endpoints in Clinical Trials
Why a sensor reading is only as good as its verification, analytical, clinical and usability validation — and the interpretation threshold that makes it an endpoint.
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Position papers
9 pages
Securing the Trial Device: Cybersecurity Obligations for Clinical DHTs
A networked device holding clinical data is a security artefact — and security is a data-integrity obligation, not optional hygiene.
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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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Position papers
9 pages
When the Phone or Gateway Is the Hub: Interoperability and Connected-Device Systems
When a hub — the participant’s phone, a tablet or a provisioned cellular gateway — bridges a sensor, wearable, spirometer or CGM, the combined system, and the device-to-device boundary, becomes the regulatory unit.
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