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    Clinical investigations

    Clinical Investigations 101

    Are you considering a clinical investigation or evaluation for your medical device but unsure where to start? Would you like some help figuring out which aspects to outsource and what steps to take before contacting a Contract Research Organization (CRO)?

    Are you considering a clinical investigation for your medical device but unsure where to start? Would you like some help figuring out which aspects to outsource and what steps to take before contacting a Contract Research Organization (CRO)?

    This short self-study course, consisting of 8 modules, is intended to help those who work with new medical devices and are unfamiliar with the complex world of planning, execution and reporting medical device clinical investigations.

    If you are planning a clinical study for your device, this course will equip you with essential concepts and terminology and offer guidance on contacting a CRO that can help your product succeed.

    Please note that Clinical Investigations 101 focuses on the investigations of medical devices. It does not cover the specifics of IVD medical device clinical performance studies.

    Topics

    • What is a clinical investigation of medical devices?
    • The types of clinical investigations
    • Clinical study timeline
    • Planning a clinical investigation project
    • Preparing a budget for a clinical study
    • Mandatory competences required for a clinical study
    • The connection between clinical investigations and a technical file
    • Common pitfalls to avoid

    Target group

    Clinical Investigations 101 is designed to teach how to start a clinical investigation. This makes the course particularly useful for medical technology start-ups, research-to-business projects (R2B), university spin-offs, and anyone preparing to launch their first medical device in the EU market.

    Objectives

    • Will know the basics for successful clinical investigations
    • Are familiar with the core concepts of clinical investigations and terminology
    • Have basic knowledge of planning, scheduling and budgeting a successful clinical study
    • Are able to pinpoint the outsourced expertise needed for your project
    • Know what to have in place before contacting a CRO