Case Report Form (CRF) design & development
Data management plan
Database design, setup, testing & validation
Edit check programming and testing
Data entry
Data validation & query management
Data integration
Reconciliation of external data
Medical coding using industry standard dictionaries (MedDRA® and WHODrug®)
Database lock & database transfer in client’s preferable format
Data preparation for analysis
Validated Data Management System
& Regulated Environments :
• 21 CFR Part 11 compliant
• Clinical Data Interchange Standard Consortium (CDISC gold membership)
• Standard Data Tabulation Model & Reporting
• Standard MedDRA coding & ConMed coding
• Customized computerized system for clinical study management; e.g., AE alert, on-line X-ray image cross-checking
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