EDC and CDISC: What’s In It For You

Advantages of EDC:

• Realtime access to clinical data
• Support of mid-study decisions (e.g., regarding recruiting, project management, etc.) which also enables adaptive trial designs
• Very high quality of data
• Less data errors through immediate plausibility checks
• Precise information about the study status
• Quick database closure
• Quick study termination

-› Higher quality of data in a very short period of time

Advantages of CDISC:

• CDISC (Clinical Data Interchange Standards Consortium) is a standard for electronic data capture supporting the development of medical and biopharmaceutical products
• More efficiency in the implementation of clinical trials
• Easier review of data submitted to authorities (EMEA/FDA)
• Higher quality of data through exact data consistency
• Standardized data model for all trials