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
5 pages
Where the Data Actually Travels
A companion reading from the connectivity provider seat — what routing and egress do, and do not, do to a trial’s data-protection position
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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
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
Consent on a Screen: The Regulatory Anatomy of eConsent
Why electronic informed consent sits across electronic signature, data protection and GCP / ethics — all at once — and why acceptance is not universal.
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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
10 pages
Continuous Monitoring, Consent and Participant Burden
Why always-on data collection reshapes consent, withdrawal and data minimisation — and why convenience is not the same as proportionality
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