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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.

4 papers tagged “Decentralised trials”
Patient Engagement — service brochure qointa Services brochures Free 2 pages

Patient Engagement — service brochure

Patient engagement services that strengthen the patient–provider relationship to improve adherence, insight and outcomes.

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Digital Trials and the Device Perimeter: A Regulatory Primer Position papers Free 6 pages

Digital Trials and the Device Perimeter: A Regulatory Primer

A plain-language entry point to the regulatory questions raised by the devices and systems a clinical trial relies on — wearables and sensors, home and point-of-care instruments, apps and eCOA platforms, clinical systems, and the phones and tablets that connect them

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Data Residency and Cross-Border Transfer in Decentralised Trials 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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Risk-Based Monitoring and Device Telemetry in Decentralised Trials Position papers 8 pages

Risk-Based Monitoring and Device Telemetry in Decentralised Trials

Why the device is a monitorable data source — and why its telemetry belongs in the risk-based monitoring plan, not outside it

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