Data Management
Clinical data capture, validation, and delivery for reliable analysis.
EDC database design
- eCRF development:
Electronic case report form creation and validation rules setup - Database build:
Study-specific database configuration and testing procedures - User management:
Access controls, role assignments, and training coordination - System validation:
Database testing, UAT coordination, and go-live preparation
- eCRF development:
Data validation and cleaning
- Real-time monitoring:
Automatic edit checks and data validation during entry - Query management:
Discrepancy identification, query generation, and resolution tracking - Data review:
Medical and statistical review of collected data for consistency - Quality control:
Source data verification and data integrity assessments
- Real-time monitoring:
External system integration
- Laboratory integration:
Central lab data import and reconciliation procedures - ePRO connectivity:
Electronic patient-reported outcomes data collection - IWRS integration:
Interactive web response system for randomization and supply - Safety database:
Adverse event data transfer and pharmacovigilance integration
- Laboratory integration:
Data export for analysis
- Dataset preparation:
Clean data extraction and formatting for statistical analysis - CDISC compliance:
SDTM and ADaM dataset creation for regulatory submissions - Quality checks:
Final data validation and audit trail documentation - Delivery coordination:
Secure data transfer and statistician handover procedures
- Dataset preparation:
