Case study · SaMD & clinical trials

Clinical-grade software, delivered under trial conditions

Bringing software architecture, quality system, and regulatory pathway into a single technical picture — so a digital therapeutic could progress through clinical trials without the strands pulling apart.

Client

Closed Loop Medicine

Role

Technical lead / advisor

Stage

Clinical trials · SaMD

Focus

Architecture · Quality · Evidence

A smartphone medication app alongside a connected pill dispenser

The challenge

A clinical-grade product had to satisfy trial protocol, regulatory expectations, and a real delivery timeline at once — while the science, software, and regulatory strands were being planned and managed largely in isolation.

Left unmanaged, that separation is exactly where the chain from scientific idea to deployable, regulated product tends to break.

The approach

The strands were worked as one technical picture rather than four separate workstreams:

Software architecture and quality system designed together, aligned to the intended regulatory pathway from the start.

Engineering practices set up to generate the evidence that trials and auditors expect — not retrofitted later.

Scope sequenced so the highest-risk technical bets were proven first, de-risking the delivery timeline.

The outcome

Software and trial systems delivered to clinical standard, supporting the product’s progress through clinical trials — and contributing to successful Innovate UK grant applications to the company’s name.

Illustrative detail — specific figures and artefacts shared directly on request.

At a glance

A regulated digital therapeutic, delivered under live clinical-trial conditions.

Services drawn on

SaMD & Regulated SoftwareFractional CTO

Disciplines bridged

Science · Software · Regulatory

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