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Clinical Study Support


Clinical Study Strategy & Design

  • Development of clinical research strategy

  • Scientific Review

  • Preparation of Clinical Investigation File:

    • Study Protocol

    • Case Report Forms

    • Investigator's Brochure

    • Informed Consent in accordance with local regulation

    • Labeling

Clinical Study Strategy & Design: Scientific review, study protocol, case report form, informed consent
Clinical Study Management: Etichs commitee, IRB, site initiation, study management

Clinical Study Management

  • Submissions to ethics committees and regulatory authorities

  • Investigational site evaluation and selection including Key Opinion Leaders.

  • Site initiation and closure report

  • Periodic monitoring and reporting

  • Study management and coordination

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