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
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
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.
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
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.
Read the summary →
Position papers
9 pages
QMS Integration: Embedding DHT Controls across Sponsor and Vendor Quality Systems
Why the seam between GCP, ISO 13485 and software-lifecycle quality systems is where DHT control is won or lost.
Read the summary →
Position papers
9 pages
Consent on a Screen: The Regulatory Anatomy of eConsent
Why electronic informed consent sits across electronic signature, data protection and GCP / ethics — all at once — and why acceptance is not universal.
Read the summary →
Position papers
8 pages
ALCOA+ on the Device: Device-Side Data Integrity in GCP
When a device captures trial data — a handset, a wearable, a home instrument or the gateway that relays them — attribution, time and protection against alteration are decided on the device, and no validated database can decide them later.
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