Focused Clinical Evidence Package

Ireland has become a significant centre for life sciences and health-tech investment. Irish companies in the sector raised a record €491.3 million across 89 venture capital deals in 2024, while Ireland has been ranked as Europe’s leading life sciences and health-tech destination for venture capital investment per capita. More than 400 indigenous companies now operate across the sector.

The wider startup environment is also growing. Enterprise Ireland invested €32.9 million in Irish startups in 2025, supporting 198 companies, including 90 High Potential Start-Ups.

But for an early-stage medical device company, developing the technology is only part of the challenge.

Atlantia has developed its new Focused Clinical Evidence Package specifically around this gap.

Rather than reducing the scope of a larger pivotal trial, the programme is designed from the outset around a focused question: whether the device performs safely enough to support progression to the next stage of investment and development.

The working model involves 20 participants at a single clinical site, with screening, baseline and end-of-study visits. Studies are structured around two efficacy endpoints and one safety or usability endpoint, followed by statistical analysis and an executive summary report.

The package has a working budget of €70,000, or approximately $85,000 in the US, providing startups with a defined entry point into human clinical research before taking on the cost and complexity of a larger programme.

The Working Model

Screening, baseline, and end of study visits, built around two efficacy endpoints and one safety or usability endpoint, with statistical analysis and an executive summary report, plus pass-through costs such as regulatory fees and materials.

Participants

Site

Visits

Endpoints

1 Regulatory

Regulatory pathway confirmation before protocol work begins.
HPRA, NREC-MD and FDA application preparation.

2 Study Design

Protocol built around the screening, baseline, and end of study structure.
Informed consent documentation.

3 Delivery

Site set-up and monitoring for one site.
Data Management through database lock.

4 Reporting

Statistical analysis across all three endpoints.
Executive summary report suitable for investors.

Medical Device Trials at Atlantia

Atlantia combines scientific depth with operational precision to provide the best medical device CRO services in the United States and Europe available to fit a variety of budgets. Our expertise in medical device CRO solutions spans every stage from concept protocols to real-world evidence. Whether you're preparing a submission for the FDA, EU MDR, conducting post-market studies in the EU, or first in human studies, our expert team brings the regulatory and operational experience needed to support device trials across regions.

Focused Clinical Evidence Package

The Working Model

Participants

Site

Visits

Endpoints

Who This is For?

Pre-seed or seed stage companies without a completed clinical investigation.

Companies that need evidence for an investor conversation.

Devices with no prior human data, or only feasibility-level data.

What's Included?

Medical Device Trials at Atlantia

Let's Discuss Your Device