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
Information Systems QMS Audit — service brochure
Information systems QMS and audit — internal audit, supplier audit and QMS readiness for IT organisations.
Download PDF →
qointa Services brochures
Free
2 pages
Quality & Regulatory Assurance — service brochure
Quality and regulatory assurance — QMS design, regulatory strategy and ongoing compliance support for life-science organisations.
Download PDF →
Device360 Brochures
Free
4 pages
Device360 — the full suite
How the eight modules fit together into one governance loop, from classification to inspection readiness.
Download PDF →
Device360 Brochures
Free
2 pages
AuditPrep — inspection readiness
Audit-ready documentation binders, mock audits, CAPA logs and portfolio lifecycle traceability.
Download PDF →
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
Read the summary →
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
Read the summary →
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.
Read the summary →
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.
Read the summary →A paper raised a question about your study?
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.
Book a 15-minute call