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Franklyn Health

  • Your Device,
    Our Promise

    Franklyn Health is a full-service European Medtech Clinical Research Organisation (CRO) built for small and midsize device or diagnostic manufacturers worldwide. From first study design through to post-market follow-up, your project is always our priority. With 100+ studies led and dozens of devices launched, we offer the consistency and responsiveness large CROs can’t match — with tailored, transparent pricing every step of the way.​

  • Built For​
    Medtech

    Your device or diagnostic deserves a CRO that lives and breathes Medtech. With Franklyn Health, you get a partner who understands MDR/IVDR, CE/UKCA and FDA requirements inside out. We’ll shape your regulatory strategy, design and run your study, and deliver the evidence you need to get to market faster – so you can focus on the science. ​

  • Transparent Partnerships,
    Tailored Solutions

    At Franklyn Health, we believe every clinical study is unique, so your partnership with us should be too. We provide clear, transparent budgets and adaptable pricing models that align with your project’s needs. No hidden costs. No unexpected changes. Just open communication and a collaborative approach designed to keep your study moving smoothly and efficiently.

  • Smarter Studies,​
    Faster Results

    At Franklyn Health, we combine smart technology with expert oversight to deliver faster, more efficient studies. Our proprietary regulatory intelligence technology powers faster study startup by increasing quality and eliminating bottlenecks – thereby lowering costs and delivering a smoother pathway to first patient enrolled.​

  • Trusted Team,​
    Shared Success

    Our team has worked together for years on both sides of the sponsor–CRO table, leading global studies and bringing devices to market for some of the world’s largest manufacturers. We built Franklyn Health to be the CRO we always wanted to work with — one that puts every project first. As an employee-owned company, we are personally invested in your success, treating every study like it’s our own.​

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EU and FDA protocols written

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Clinical investigations executed

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Devices brought to market

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Patients enrolled to date

Your Device,
Our Mission.

The clinical evidence you need – to launch, grow and stay ahead.​

Franklyn Health is a European CRO built for small and midsize medtech manufacturers worldwide. Our expert team bring decades of experience delivering clinical evidence for device and diagnostic partners, combining deep regulatory insight with practical trial delivery.

Your device has the power to change lives. With transparent pricing and hands-on leadership, our senior team deliver high-quality studies and regulatory support as your dedicated clinical partner, providing the strategic guidance, consistency and responsiveness you need to transform innovation into patient impact.

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FULL SERVICE CRO:

Your medical device & diagnostic clinical partner from day one. From first draft of your protocol to final regulatory submission and post-market follow-up, you can count on our expertise every step of the way.​

Regulatory
Strategy

We build global strategies covering MDR, IVDR, FDA, and UKCA to accelerate market access.

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Study Design
& Protocol

We design practical studies that balance science and regulation — reducing risk and accelerating approvals.

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Study
Startup

We manage site contracts and ethics/ regulatory submissions to increase quality, avoid delays and reduce costs.

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Site Selection
& Monitoring

We connect you with top-performing sites and ensure data integrity through proactive, hands-on monitoring.

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Clinical Study
Management

Our team drives enrolment, ensures compliance, and provides clear updates to keep your study on track.

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Data Management
& Biostatistics

We deliver clean, reliable data and expert biostatistics for robust, compliant analyses and submissions.

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Medical
Writing

We create clear, compliant documents that communicate results effectively across MDR, IVDR, FDA, and UKCA requirements.

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OUR TEAM HAS LED AND DELIVERED COMPLEX TRIALS FOR

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