EXPERTISE
Since your medical device is unique, the clinical trial we provide is unique as well. We do not work with off-the-shelf solutions, and we provide only what your clinical trial really needs. Our specialists are all senior experts, and you will encounter honest advice, experienced project management, and a well-done clinical trial.
Because Every Device Deserves a
Unique Clinical Path
Since your medical device is unique, the clinical trial we design for you will be too.
Our senior specialists bring decades of experience and the kind of honest, practical advice that only comes from real-world expertise.
We combine global reach with AI-driven tools for smarter site selection, faster recruitment, and flawless data management
— ensuring your trial runs smoothly and successfully.
Clinical Studies
Design, manage, and execute your clinical trial with confidence. From feasibility and protocol design to monitoring, reporting, and submission, we ensure every step is data-driven and compliant.
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Draft clinical protocols
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Prepare submission dossier
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Smart feasibility and Site selection (AI-powered)
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EDC/eTMF design, programming, and validation
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Full study management on-site and remote (open to close)
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Data management and monitoring
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Clinical Reports
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DSMB / CEC management
Regulatory Services
Navigate complex FDA and CE pathways with a team that knows every turn. From pre-submissions and 510(k) applications to CERs and Technical Files, we guide your device efficiently and effectively.
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FDA
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Pre-submissions
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Regulatory Strategy
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510K Applications
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De novo Applications
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CE
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Complete Technical File
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Appraised Literature Review
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CER
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PMS
Usability Testing
We design and conduct formative and summative studies that stand up to scrutiny — and help you prove your device is safe, intuitive, and compliant with regulatory expectations.
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URRA
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Usability protocol for formative and summative studies
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Interim final reports
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Moderator guide
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Usability studies (real and simulated environment)
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Usability report for regulatory authorities
