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

<

STAY IN TOUCH