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
7 pages
The eCOA / ePRO Vendor’s Hidden Obligations
A companion reading from the vendor’s seat — where your build and release choices place you inside the perimeters
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Position papers
9 pages
Qualification of Digital Endpoints for Regulatory Decision-Making
Why validation produces the evidence — and qualification is the separate regulatory decision that the evidence is fit for a defined context of use.
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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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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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