Julie GATEL
Head of Clinical Operations
More than 15 years of experience in clinical research, working with different types of structures: pharmaceutical laboratories, CROs, NGOs, medical technology companies and public hospitals.
Expertise in the clinical development process at both national and international levels.
Services and Expertise
Your success : our challenge
Within Medical Initiatives, our operational expertise extends from the design of a study project to the clinical study report, including :
Preparatory phase of studies
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Site selection
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Feasibility
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Writing study documents (Protocol, Consent form, CRF...)
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Translation of study documents
Regulatory submission phase
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Competent authorities for health products and clinical research
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Ethics committees
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Council of Physicians
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Data protection authorities
Start-up and follow-up phase of the study
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Site Initiation Visit
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Global coordination
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Investigational products and biological samples management
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Monitoring
End-of-study phase
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Close-out of sites
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Quality assurance / queries management
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Participation in Data Review
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Clinical Study Report
These activities are managed by a multidisciplinary operational team relying on essential expertise (project management, coordination, regulations, field experience) and a robust internal Quality System.
MEDICAL INITIATIVES is in the process of ISO certification