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.
Brochures
Free
1 page
DHT governance — the one-pager
Govern the devices your trial relies on before an inspector does — the seven regulatory perimeters, on one page.
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qointa Services brochures
Free
2 pages
Strategy & Thought Leadership — service brochure
Thought leadership, business and project strategy, development and implementation services for life-science companies.
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qointa Services brochures
Free
1 page
qointa service overview
qointa's full service portfolio across quality management, regulatory compliance, software development, contract research, patient engagement and digital transformation.
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Position papers
Free
16 pages
Regulatory Impact Assessment (RIA) for Devices and Systems in Clinical Trials
Why a device’s role and triggers — not the hardware — determine whether an RIA is required
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Brochures
1 page
The DHT governance framework on a page
The qointa DHT governance and service-delivery framework on a single page — one controlled loop, run until the study closes.
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Position papers
11 pages
Digital Health Technologies in Clinical Trials — A Regulatory Position-Paper Series
One device, several perimeters: a framework for assessing the regulatory impact of the technologies a trial relies on.
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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.
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