VAXXIUM

e-CRF AND e-PLATFORM

VAXXIUM provides integrated Clinical Data Management services from study design to study close-out

01.STUDY SETUP

Input in CRF design
e-Platform setup (incl. ePRO/IWRS), testing & validation
Annotated CRF
Data Validation Plan (DVP)
Data Management Plan (DMP)
Data Cleaning Plan (DCP) & Programming
Data exchange with external data sources and systems (in/out)
eCRF completion guidelines

02.STUDY CONDUCT

e-Platform and database hosting
Data Cleaning Process
Risk-based 1st line or 2nd line Database Monitoring
Data exports
AE/SAE reconciliation
Quality control: data entry, programming of validation checks, entry of queries

03.STUDY CLOSE-OUT

Data reconciliation across multiple sources and systems
Database lock, transfer & archiving
Data Management Report
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