VAXXIUM

MEDICAL WRITTING

VAXXIUM provides integrated clinical services from study design to study close-out

01.STUDY SETUP

—Protocol writing/review

—CRF writing/review

—Informed Consent Form (ICF)

—Input to SAP

—Investigator's Brochure (IB)

—Investigational Medicinal Product Dossier (IMPD)

—Common Technical Document (CTD all modules)

02.STUDY CONDUCT

—Set up and Management of the Data Safety Monitoring Board (DSMB)

—Update of the documents (amendment)

03.STUDY CLOSE-OUT

—Clinical Study Report (CSR)

—Publication

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