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.
qointa Services brochures
Free
2 pages
CSV Maintenance — service brochure
Keeping validated systems in a validated state — periodic review, change control and revalidation for computerised systems.
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qointa Services brochures
Free
2 pages
Computer System Validation — service brochure
Computer system validation across the full lifecycle, from validation planning and risk assessment through to execution and reporting.
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qointa Services brochures
Free
2 pages
Information Systems Compliance — service brochure
Information systems compliance — bringing IT processes, controls and documentation into line with GxP expectations.
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qointa Services brochures
Free
2 pages
Infrastructure Qualification — service brochure
Infrastructure qualification and IT service management — qualifying the platforms and environments that GxP systems run on.
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qointa Services brochures
Free
2 pages
Medical Device Software Development — service brochure
Medical device software development, from planning and requirements through risk management (ISO 14971), development and verification.
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Device360 Brochures
Free
2 pages
DeviceFit — fit-for-purpose validation
Technical, clinical and operational validation aligned to ISO 14971, IEC 62366-1, FDA QSR, EU MDR Annex I and ICH-GCP.
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Position papers
Free
5 pages
The Control Plane Is Part of the Trust
A companion reading from the device-management vendor seat — what the control plane must evidence, and when constraining a device is someone else’s regulatory problem
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Position papers
Free
5 pages
The Handoff Is in Validation Scope
A companion reading from the clinical-systems vendor seat — why the integration boundary, not the device, is where the regulated record is made
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Position papers
9 pages
You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3)
The sponsor’s duty to qualify and oversee its DHT vendors — distinct from who holds the economic-operator role.
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Position papers
8 pages
Designed for the Hand That Holds It: Human Factors and Use-Safety in Trial DHTs
Why usability and use-error are regulated concerns for participant-facing devices — and why the population, and the risk, set the bar.
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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
9 pages
Integrating DHTs with EHRs and Clinical Systems
Why the boundary between the device and the clinical system is the regulated unit — and why provenance must survive the handoff
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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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