i-clinics offers efficient and streamlined Data Management services from design and printing of case report forms through data entry and cleaning to produce high quality databases, whether the original CRF is collected via EDC or paper.
- CRF design (paper, EDC) and development
- Data management plan development
- CRF completion guidelines
- Automated production of annotated CRF
- Database build, design and testing
- Data validation plan
- Edit checks programming and testing
- Paper data processing via double data entry or assisted by OCR (Optical Character Recognition)
- Query management
- Medical coding with MedDRA and WHO Drug dictionaries
- Safety data reconciliation
- Blind review and meeting
- Database lock
- Data export to SAS
- Standard and dedicated reports
- Management of ancillary documents
- Overall quality control measures