Build

What to build, and what to measure

Most evidence problems are settled before anyone writes a protocol, in the product decisions that fix what you can ever demonstrate.

We work with teams at that point:

  • Defining the clinical use case
  • Establishing what has to be true for a clinician to act on your output
  • Building the path from what you can claim now to what you need to claim

We also hold the named Clinical Safety Officer role under DCB0129, for companies who need a registered clinician and do not have one.

More on the CSO role

Human-State Measurement Strategy
Strategy memo

The measurement stack, decision tree and risk notes, as a written report.

Detailed measurement plan

The memo, plus fuller measurement planning around it.

Which measures to use, before there is a claim to test them against.

A recommended measurement stack for your stated product or study goal: physiological and subjective measures paired against the use case, a decision tree for when each applies, and named risks and limitations per measure.

For companies who have not built the product yet, or whose claim is not fixed, deciding what to measure and how before there is anything to validate.

This chooses the measures. Evidence Review tests whether measures you already chose support the claim you are making.

Validation Study Design
Review

A written critique of the endpoint, reference standard, annotation methodology, population and analysis plan of a protocol you already hold, with required changes specified and prioritised.

Design

A full protocol built from your claim: claim-to-endpoint mapping, reference standard construction, annotation methodology, population, sample size justification and statistical analysis plan, delivered as a document a site can execute against and an ethics committee can review, with a site selection note.

A protocol written from your claim, not from a template. Or a critical review of the one you have.

For companies with a protocol in hand who need it stress tested before it goes to a site or an ethics committee, or with a study concept who need it built properly the first time.

The review criticises what exists. The design creates what does not. If you hold a written protocol with an analysis plan, an annotation manual and a sample size justification, you need the review. If you hold a study concept, you need the design.

Study Delivery, End to End

Metriqx can run the validation study, not just design it.

Chief Investigator responsibility for the whole study: ethics governance, data collection and analysis, through to the final validation report, as one accountable engagement rather than a set of separate commissions.

For companies who want Metriqx to hold full delivery responsibility for a validation study, not just design it.

Validation Study Design hands you a protocol to run yourself. This runs it: Metriqx carries delivery risk for the whole study, not just its design.

Clinical Product Advisory
Clinical use-case definition

A document setting out the clinical problem, the intended user, the decision the output informs, and the endpoint that would demonstrate it.

Retainer

Ongoing claim architecture, endpoint selection, clinical review of design decisions before they are built in, and a named clinical presence for investor and NHS conversations.

The clinical use case, defined before the product fixes what it can ever claim.

For teams making product decisions that will determine their evidence ceiling, typically before or alongside a study.

Assessment tells a company what it got wrong. Advisory stops it happening.

Named Clinical Safety Officer

Onboarding and safety-case baseline

One-off, required before the role is accepted.

Retainer

Ongoing review across releases, at a cadence to match how often you ship, with additional sign-offs beyond the allowance priced per event.

All services