Clinical Data Management

We offer extensive data management and other services for both EDC and paper based clinical trials, including:

• (e)CRF design
• (e)CRF completion guideline including site training
• Database setup and maintenance
• CRF tracking and status reporting
• Data handling plan
• Data entry (single and double)
• External data integration (e.g. central laboratory data, ECG data, etc.)
• Data validation and query management
• Medical review by physicians
• SAE reconciliation
• Coding (MedDRA, WHO-Drug Dictionary)
• Data mapping (e.g. ODM, STDM, ADAM according to CDISC standard)
• Database transfer