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Regulatory and Pivotal clinical trial design

Our Experience
 

We help healthcare technology innovators design robust, compliant, and patient-centred clinical trials for medical devices, Software as a Medical Device (SaMD), and AI as a Medical Device (AIaMD). Our expertise spans pre-regulatory studies, pivotal trials, and real-world evidence generation, ensuring your product meets regulatory standards while demonstrating clinical and economic value.

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Our founder is a member of a Healthcare Regulatory Authority Research Ethics Committee. This allow sus to help you navigate the necessary permissions for your trial.

Our services

  • Pre-Regulatory Trial Design

    • Feasibility and usability studies

    • First-in-human and early clinical evaluations

    • Protocol development aligned with MHRA requirements

  • Pivotal Clinical Trial Design

    • Endpoint selection and recruitment planning

    • Integration of health economics and value proposition

    • Patient and Public Involvement (PPI) strategy and delivery

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