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
7 pages
When the Instrument Is Their Own Phone
A paper about the participant’s position on a bring-your-own-device trial — written for the sponsor, sites and vendors who must discharge the obligations that anchor to them
Read the summary →
Position papers
8 pages
Designed for the Hand That Holds It: Human Factors and Use-Safety in Trial DHTs
Why usability and use-error are regulated concerns for participant-facing devices — and why the population, and the risk, set the bar.
Read the summary →
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
Read the summary →A paper raised a question about your study?
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.
Book a 15-minute call