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.
Brochures
Free
1 page
DHT governance — the one-pager
Govern the devices your trial relies on before an inspector does — the seven regulatory perimeters, on one page.
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qointa Services brochures
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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
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2 pages
Data Integrity — service brochure
Data integrity services built on ALCOA+ — governance, gap assessment, remediation and controls across GxP data.
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qointa Services brochures
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2 pages
Digital Transformation — service brochure
Digital transformation support for clinical and quality operations — target operating model, process redesign and adoption.
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qointa Services brochures
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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
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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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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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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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qointa Services brochures
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2 pages
Quality & Regulatory Assurance — service brochure
Quality and regulatory assurance — QMS design, regulatory strategy and ongoing compliance support for life-science organisations.
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qointa Services brochures
Free
2 pages
Strategy & Thought Leadership — service brochure
Thought leadership, business and project strategy, development and implementation services for life-science companies.
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Brochures
Free
4 pages
The qointa brochure
The qointa brochure in print format: what we do, for whom, and how an engagement runs.
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qointa Services brochures
Free
1 page
qointa service overview
qointa's full service portfolio across quality management, regulatory compliance, software development, contract research, patient engagement and digital transformation.
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Position papers
Free
16 pages
Regulatory Impact Assessment (RIA) for Devices and Systems in Clinical Trials
Why a device’s role and triggers — not the hardware — determine whether an RIA is required
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Position papers
Free
10 pages
The Smartphone in Digital Endpoints
Indispensable conduit, immature instrument — the phone’s role in capturing, processing and submitting digital endpoint data
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Device360 Brochures
Free
4 pages
Device360 — the full suite
How the eight modules fit together into one governance loop, from classification to inspection readiness.
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Device360 Brochures
Free
2 pages
DeviceReg — regulatory classification and filing
Jurisdiction-specific classification, regulatory justification packages, change control and protocol-amendment impact mapping.
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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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Device360 Brochures
Free
2 pages
DeviceOps — logistics and lifecycle
Labelling, UDI, importer-of-record, chain of custody, mid-study replacement and field safety corrective actions.
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Device360 Brochures
Free
2 pages
DeviceConnect — data interoperability
Data-flow mapping, ALCOA+ metadata standardisation, time-synchronisation controls and AI/ML traceability.
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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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Device360 Brochures
Free
2 pages
AuditPrep — inspection readiness
Audit-ready documentation binders, mock audits, CAPA logs and portfolio lifecycle traceability.
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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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Position papers
Free
7 pages
When the Instrument Is Their Own Phone
A paper about the participant’s position on a bring-your-own-device trial — written for the sponsor, sites and vendors who must discharge the obligations that anchor to them
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Position papers
Free
6 pages
What the Trial Needs From the Handset Maker
A companion reading from the phone manufacturer / OEM (original equipment manufacturer) seat — what the trial needs from you, and why none of it is your obligation
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Position papers
Free
6 pages
Your Device, and the System It Joins
A companion reading from the wearable / biosensor manufacturer seat — your own obligations, and the system the bridge creates
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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
6 pages
The Provisioning Chain’s Inherited Duties
A companion reading from the logistics / provisioning vendor seat — how sourcing and configuration draw operator and end-of-life duties
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Position papers
Free
5 pages
Where the Data Actually Travels
A companion reading from the connectivity provider seat — what routing and egress do, and do not, do to a trial’s data-protection position
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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 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
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
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
Free
6 pages
What an Ethics Committee Can Require
A companion reading on the ethics-committee lens — written for the sponsors, CROs and study teams who prepare the submission
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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
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Position papers
Free
8 pages
Harder Populations, Higher Bar — Paediatric and Vulnerable Participants
A cross-cutting reading of the series — the perimeters do not change, but the evidence each one demands rises, and every rise has a rule behind it
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Brochures
1 page
The DHT governance framework on a page
The qointa DHT governance and service-delivery framework on a single page — one controlled loop, run until the study closes.
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Position papers
11 pages
Digital Health Technologies in Clinical Trials — A Regulatory Position-Paper Series
One device, several perimeters: a framework for assessing the regulatory impact of the technologies a trial relies on.
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Position papers
9 pages
Who Is the Manufacturer? Economic-Operator Roles in DHT Supply Chains
How provisioning, importing, kitting and modifying a device assign manufacturer, importer and distributor duties — often by operation of law.
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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
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.
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Position papers
8 pages
Change Is the Risk: Managing App, OS and Firmware Updates Across a Live Trial
A feature added in a routine update can cross a perimeter mid-study. Why change is a regulated event — and how to tell which changes are material.
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Position papers
8 pages
Predetermined Change Control Plans (PCCP) for AI/ML in Trial DHTs
Why an evolving on-device model needs a pre-agreed change plan — and why the regulatory timeline is the part most easily misjudged.
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Position papers
12 pages
Vigilance and Post-Market Surveillance for Trial DHTs
Why the reporting route turns on what the device is — and why meeting one route never discharges another.
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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.
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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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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
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.
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Position papers
9 pages
The End of the Device: Decommissioning, Retention and Disposal in Digital Trials
Recovering, wiping, retaining and disposing of trial devices and the data they hold — the lifecycle stage the assessment forgets.
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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
10 pages
Labelling, UDI and Supply-Chain Transparency for Trial DHTs
Why the labelled article is the software, the supplied unit or the sensor — never the phone, tablet or gateway that carries it — and why BYOD makes identification harder, not exempt
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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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Position papers
11 pages
Global Reconciliation: FDA, EU, PMDA, NMPA and UK Requirements for DHTs
Why the shared requirements carry across markets and the local differences do not — and how to decide when a per-jurisdiction assessment is actually needed.
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Position papers
10 pages
Continuous Monitoring, Consent and Participant Burden
Why always-on data collection reshapes consent, withdrawal and data minimisation — and why convenience is not the same as proportionality
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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
8 pages
Diversity, Representativeness and Equitable Access in DHT Deployment
Why who a device can reach is a data-validity question — and why the durable regulatory anchor is the representativeness of the enrolled population.
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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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Position papers
9 pages
When the Device Thinks: AI/ML in Trial DHTs and the Stacking of Obligations
How an on-device model adds an AI overlay on top of the device rules — and why the 2028 application date is a trap, not a reprieve.
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Position papers
9 pages
Securing the Trial Device: Cybersecurity Obligations for Clinical DHTs
A networked device holding clinical data is a security artefact — and security is a data-integrity obligation, not optional hygiene.
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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.
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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.
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Position papers
9 pages
When the Phone or Gateway Is the Hub: Interoperability and Connected-Device Systems
When a hub — the participant’s phone, a tablet or a provisioned cellular gateway — bridges a sensor, wearable, spirometer or CGM, the combined system, and the device-to-device boundary, becomes the regulatory unit.
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