Clinical Data Management
Clinical Data Management
globeELIXIR team can handled both Paper and EDC on all standard industry platforms. globeELIXIR offers 21 CFR Part 11 compliant integrated service, stand-alone data management support on Oracle Clinical with RDC platform or remotely through a secure, direct-access connection to your clinical data management system.
Our services and activities include but not limited to (Study Phase, Conduct Phase and Lock Phase):
- Project Specific Clinical Data Management Plan
- Customized Database Design & Development
- Independent Double‐Data Entry
- Design pCRF and eCRF
- Develop CRF completion guidelines
- Query Management
- Medical Coding, SAE Data Reconciliation
- Edit, Validation and Design check
- Programming
- Data Validation
- Database Testing & UAT
- Data Migration
- Data Loading
- Data Cleaning
- Quality Control and Data Quality Audits
- Database Lock and Export to SAS
- Project Data Archival and Storage
- Documentation CDM Report