CRSClinical Research SolutionsClinician-led CRO · Excellence in research
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FAQ & insights

Straight answers about running a UK medtech trial.

The questions medtech founders and clinical leads ask us most — answered plainly, with no assumed knowledge of clinical trial jargon.

About CRS & the two models

What is Clinical Research Solutions?

Clinical Research Solutions (CRS) is a clinician-led, MHRA-approved and GCP-compliant contract research organisation (CRO) based in the UK, specialising in medtech and medical device trials. Sponsors can hire CRS to run a trial end-to-end, or bring CRS in just for the specific parts of a trial they need help with.

What is the difference between hiring CRS for the whole trial versus just specific parts?

With full-service delivery, CRS runs the entire trial end-to-end with one team and one point of contact. With flexible support, the sponsor keeps control of the trial and brings CRS in only for the specific parts they need, such as site monitoring, data management, statistics, ethics and regulatory paperwork, or quality oversight, paid for only as needed.

Is CRS's flexible model what the industry calls FSP?

Yes. In the industry this is sometimes called FSP, or functional service provision. At CRS it means the sponsor keeps overall control of the trial and brings in CRS for defined functions only, scaled up or down as the trial changes. You don't need to know the term to use the model.

Cost, speed & regulation

How can a medtech company reduce the cost of a UK clinical trial?

Cost is reduced through smart regulatory classification (using service evaluation or quality improvement routes where appropriate, which can avoid full research ethics approval), direct embedding in NHS primary care so there is no site set-up lag, and a pay-only-for-what-you-need support model. We tie every cost claim to a real project rather than a generic comparison.

What is a service evaluation, and when is it used instead of a full trial?

A service evaluation is a lighter-weight way to gather real-world evidence without needing full clinical trial approval. It suits early-stage devices that need real clinician and patient feedback on usability, workflow fit and likely adoption before committing to a larger, more expensive study.

How fast can CRS get a study started?

As little as 2–8 weeks from protocol to first patient. This is possible because we're embedded in NHS primary and secondary care, so there is no site set-up lag, and studies can run inside routine care pathways.

What credentials does CRS hold?

CRS is MHRA approved, GCP compliant, MDR aligned and Cyber Essentials Plus certified.

Network & specialisms

What are CRS's specialisms?

We have signature experience in wound care evidence generation, robotic surgery and surgical device clinical investigation, and medical devices used outside hospital — in primary care, community and home settings. We work across medtech and medical devices more broadly. See our specialisms →

Does CRS have real NHS access, or just contracts with sites?

Our clinical team is directly embedded in the NHS. Our route into primary care runs through the Primary Care Research Alliance (PCRA), the UK's largest GP-led research network, and our secondary care relationships come from our CEO's clinical career as a research nurse. How our network works →

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