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
6 pages
What an Ethics Committee Can Require
A companion reading on the ethics-committee lens — written for the sponsors, CROs and study teams who prepare the submission
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Position papers
Free
8 pages
Harder Populations, Higher Bar — Paediatric and Vulnerable Participants
A cross-cutting reading of the series — the perimeters do not change, but the evidence each one demands rises, and every rise has a rule behind it
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Position papers
8 pages
Diversity, Representativeness and Equitable Access in DHT Deployment
Why who a device can reach is a data-validity question — and why the durable regulatory anchor is the representativeness of the enrolled population.
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