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MEDICAL WRITING
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EC & CA SUBMISSIONS
CLINICAL OPERATIONS
CEVAC CLINICS – VACCINOLOGY CENTER
CEVAC IMMUNOLOGY LABORATORY
e-CRF AND e-PLATFORM
DATA MANAGEMENT
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REGULATORY AFFAIRS
INTEGRATED CLINICAL REPORT
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VAXXIUM
MEDICAL WRITTING
VAXXIUM provides integrated clinical services from study design to study close-out
01.STUDY SETUP
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Protocol writing/review
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CRF writing/review
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Informed Consent Form (ICF)
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Input to SAP
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Investigator's Brochure (IB)
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Investigational Medicinal Product Dossier (IMPD)
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Common Technical Document (CTD all modules)
02.STUDY CONDUCT
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Set up and Management of the Data Safety Monitoring Board (DSMB)
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Update of the documents (amendment)
03.STUDY CLOSE-OUT
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Clinical Study Report (CSR)
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Publication
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