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Portfolio Governance — ongoing

A retained arrangement keeping the decision register current across your device estate, with scheduled re-assessment. Automated trigger monitoring is in development; today the watch is run by a named specialist to an agreed cadence.

Fee quoted on scope
scoped per engagement
7
perimeters assessed
Living system
Govern any change

The register only works if it stays current

An assessment is true on the day it is written. A register is true continuously — but only if something keeps it that way.

This is the ongoing arrangement: we hold the register, watch the triggers, and re-assess the device that changed rather than the whole estate. Fee quoted on scope, billed monthly or yearly.

Study A · CGMStudy A · watchStudy B · eCOA appStudy C · BYOD phoneStudy C · spirometerQ1Q2Q3Q4namedspecialistscheduled re-assessment at the agreed cadence · re-assessment on notified change in between

Who this is for

Organisations past the first assessment, with more than one device across more than one study, and a register that is already drifting out of date. It suits you if you have accepted that device change is continuous and you do not want to reassemble the argument from scratch every time a supplier ships firmware. It is the wrong fit for a single device in a single study — that is a Snapshot RIA with a scheduled re-assessment on it.

What you receive

  • Maintained decision register across every device and study
  • Scheduled re-assessment, and re-assessment on notified change — run by a specialist
  • Quarterly portfolio review and risk report
  • Regulatory change watch across your jurisdictions
  • Named specialist and an agreed response time

What you provide

  • Access to your device inventory and change notifications
  • A named counterpart in quality or clinical operations
  • Notice of new studies and protocol amendments
PORTFOLIO GOVERNANCE MODELS · DHT-ENABLED TRIALS Hitting every milestone ≠ inspection-ready MILESTONE TRACKING tracks timelines Every milestone hit. Perimeter open. PORTFOLIO GOVERNANCE keeps you inspection-ready Milestones hit. Perimeter closed · evidence locked. vs A milestone measures motion. The perimeter measures exposure.

Milestone tracking turns every milestone green. Portfolio Governance does the same — then closes the perimeter an inspector actually walks, locking the evidence at each milestone instead of reconstructing it later.

What you provide
Access to your device inventory and to the change notifications you receive from suppliers, so the watch is fed rather than guessed. A named counterpart in quality or clinical operations who can confirm what has changed and authorise the register entry. Notice of new studies and protocol amendments, ideally at the point they are drafted rather than executed. Governance works on notification: what we are not told about, we cannot re-assess.
What is excluded
The retainer covers maintenance of the register at the agreed cadence and re-assessment on notified change. It does not include: onboarding devices never previously assessed, which is quoted as Snapshot or Full Multi-Perimeter work; execution of remediation; preparation or submission of regulatory filings; validation testing or evidence generation; representation to a regulator or notified body; and it is not legal advice. Automated trigger monitoring is in development and not yet in service — today the watch is run by a named specialist to an agreed cadence, and we would rather state that plainly than imply a capability we have not shipped.
What happens next
The arrangement runs continuously and reports quarterly. Between reviews, a notified change triggers re-assessment of the device that changed rather than the whole estate, and the register entry is versioned so the prior position survives. The quarterly review covers portfolio risk, the regulatory change watch across your jurisdictions, and anything the watch surfaced that you have not yet acted on. If you end the arrangement, the register is handed over complete and in a form you can maintain yourself — it is your record, not ours.
What the output looks like

You receive a continuously maintained set of controlled artefacts: 

  1.  Maintained decision register: every device, every study, current as of the last notified change, versioned so the full history is retrievable. 
  2. Re-assessment records: each scheduled or triggered re-assessment recorded with its date, its trigger and its outcome, including outcomes of "no change required". 
  3. Quarterly portfolio review and risk report: where the estate stands, what moved, what is exposed, and what needs a decision in the next quarter. 
  4. Regulatory change watch: changes in your jurisdictions that affect a device you hold, with the affected register entries named. 
  5. Named specialist and agreed response time: one person who knows the estate, reachable within a stated window, written into the arrangement.

Where this sits among the eight

Every assessment leaves the same controlled artefacts — a recorded decision, the reasoning behind it, and the evidence index that makes it defensible. They differ in scope. This one is the standing arrangement: continuous, across the estate.

See all eight side by side →

Request this assessment

Tell us about the device and the protocol. We come back with a written scope, price and date — no obligation.

Name, manufacturer and model if you have it. List every item if there is more than one.
The single most important field. Screening, primary endpoint, secondary endpoint, safety monitoring, engagement only?
Which specific endpoints, and whether any safety decision is informed by its output.
e.g. EU, US, UK, Japan, Canada, China.
Who supplies it, whether you relabel, reconfigure or assemble kits, and whether you import into the EU.
Firmware or app updates expected, protocol amendments planned, algorithm retraining, supplier changes.
Vendor declarations, CE certificates, validation reports, prior assessments, DPIAs.
A date or a milestone.

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Before you buy: the service overview

Free, no account needed. Every service line and the framework each is written against.

Two papers behind this arrangement

Free to read with a qointa account. No sales call attached.

Digital Trials and the Device Perimeter: A Regulatory Primer Position papersFree

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

Download PDF →
You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3) Position papers

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 →

All papers in the library →