Services offered:
- Set-up of the clinical database in Oracle Clinical
- Double data entry
- Validation and plausibility checks
- eCRF/RDC (Remote Data Capture)
- Reconciliation of safety data
- Integration of Dictionaries using latest version of MedDRA and WHO ATC into the Thesaurus Management System within Oracle Clinical
Reporting of:
- Data Handling Manual
- Data Management/Validation Plan
- Data Management/Validation Report