Data Management

By working with ENNOV, we can fully guarantee quality and security, since this system meets all regulatory requirements for the creation, development and monitoring of clinical trials, and all data management processes, both in Spain and in the rest of the world.

Our team of professionals performs all the tasks required to conduct a quality clinical trial, including CRF design, database creation and validation, AE and SAE reporting and coding, as well as all the data management and entry, and the integrated coding using international dictionaries.

We offer:

• Integrated data management using the ENNOV system
• CRF design
• EDC set-up with ENNOV
• Database design and creation
• SAE reconciliation
• CDISC standards– study data packaged to CDISC-compliant standards (SDTM) and/or sponsor-specific standards
• Data export to SAS according to CDISC SDTM standards
• CRF tracking, registration and data entry (double data entry)
• Integrated medical coding (MeDRA, WHO-DD)
• Queries set-up and management.
• On-line data validation
• Off-line data validation