- CRF Design / eCRF
- CRF Completion Guidelines as per CDISC standards.
- Data Management Plan (DMP)
- Data Validation Plan (DVP)
- Checks Specification and Programming
- Testing Database Design
- Patient/CRF Tracking, Entry, and Verification
- Double Data Entry, Automated Double Data Comparison and Synchronization.
- Handling External Data (Data Import/Export)
- Medical Coding (MedDRA, WHO-Drug, WHOART, COSTART or Sponsor-developed).
- Integration and Verification of External Electronic Data.
- Remote Data Access.
- Identification and Tracking of Protocol Violators
- Electronic and Manual Discrepancy Identification and Automated Data Queries (ADQ) Generation.
- AE/SAE Reconciliation and Reporting.
- Accelerated Database Lock