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
The Sponsor’s Accountability Map
A companion reading from the sponsor’s seat — what you can delegate the work of, and what you answer for regardless
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Position papers
Free
6 pages
The Inspection Lens
A companion reading on what an inspection of a digital trial actually examines — and where the evidence has to be built long before it
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Position papers
7 pages
The Trigger Register: A Controlled Instrument for Digital-Trial Compliance
Turning the per-stakeholder assessment into a living, inspection-ready artefact in the technical file, the validation plan and the TMF — grounded in the risk-based quality management GCP already expects.
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Position papers
9 pages
Inspection-Ready: What FDA, EU and MHRA Inspectors Look For in DHT Evidence
In qointa’s experience the first inspection sets the baseline. What digital-trial evidence inspectors expect, what it is grounded in — and why it must exist before they ask.
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