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.
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Device360 Brochures
Free
2 pages
TrainReady — training and certification
Role-specific multilingual training for patients, sites and vendors, with TMF-ready logs and retraining triggers.
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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
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Position papers
Free
7 pages
The eCOA / ePRO Vendor’s Hidden Obligations
A companion reading from the vendor’s seat — where your build and release choices place you inside the perimeters
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Position papers
Free
5 pages
The Update You Ship Is a Trial Event
A companion reading from the OS / firmware vendor seat — why your release is the sponsor’s change event, and what only you can tell them about it
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Position papers
Free
5 pages
Where the Evidence Is Actually Made
A companion reading from the CRO and site seat — which duties are yours, which are the sponsor’s, and which control belongs to neither of you
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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
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 →A paper raised a question about your study?
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