Franklyn Health
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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.
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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.
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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.
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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.
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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.
00+
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