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    Clinical Investigations 101

    CLINICAL INVESTIGATIONS

    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.

    Inhalt

    • 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
    Registrieren

    Trainer

    Markus Vattulainen
    Markus Vattulainen
    Data Manager
    markus.vattulainen@aurevia.com

    Markus Vattulainen is a Data Manager in Labquality's CRO business. His responsibilities include designing clinical device research, modeling research data flows, server environments, data collection systems (ECRF), document management systems (TMF, ISF), programmatic controls for data quality, technical data security, and data protection for clinical research (GDPR).

    Maria Malm
    Maria Malm
    Clinical Study Manager
    maria.malm@aurevia.com
    Annika Astola
    Annika Astola
    Team Lead, CRO Services
    annika.astola@aurevia.com

    Zielgruppe

    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.

    Nach diesem Training

    • 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

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    RECHNUNGS- UND STORNIERUNGSBEDINGUNGEN

    Lesen Sie hier die Abrechnungs- und Stornierungsbedingungen für Online-Schulungen.

    Die Teilnahme an der Schulung kann zwei Wochen (14 Tage) vor der Veranstaltung kostenfrei storniert werden. Bei Stornierungen, die danach erfolgen, berechnen wir 50 % der Teilnahmegebühr, bei Stornierungen, die eine Woche vor der Veranstaltung erfolgen, berechnen wir 100 % der Teilnahmegebühr.

    Stornierungen erfolgen immer schriftlich an: koulutus@aurevia.com.  
    Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@aurevia.com meldet. Die Teilnahmegebühr wird unmittelbar nach der Veranstaltung in Rechnung gestellt. Die Trainingseinheit wird dem Teilnehmer ca. eine Woche vor der Veranstaltung per E-Mail bestätigt. Labquality behält sich das Recht vor, die Schulung aufgrund einer zu geringen Teilnehmerzahl abzusagen.