S-EDC

S-EDC, the S-Clinica EDC (Electronic Data Capture) and Data Management system, has been developed accounting for two key success factors:

• Ease of use
• Powerful user assistance via automated processes

S-EDC integrates within one system all aspects of remote data capture, data management and communication between study participants.

S-EDC, central randomization and drug supply management services are offered on a fully integrated platform with a single interface.

Using this system, our highly qualified data managers offer a full range of data management services in all study phases.

Key features:

• eCRF designed for comfortable data entry by investigative site personnel
  • Intuitive data capture
  • Dynamic screens and interactive pages
  • Easy navigation
  • Auto-save
  • A range check doesn’t block filling in pages, doesn’t slow down nor prevent data entry
    
• Web-based system
  • No installation needed
  • Accessible from any computer
    
• Easy and prompt data clean up
  • Intelligent query management system
    • Real-time automated generation of queries from simple range checks to complex cross-page consistency checks
    • Answering: in CRF pages or in Query Window
    • Real-time automated resolution of redundant queries; a corrected value eliminates all related queries
• Improved system of manual queries or notes
• Emitted by CRA or Data Manager
• Can be attached to any item (center, patient, visit, page, data)
• Specific management of SDV related queries
  
• Full integration with S-IVRS (the S-Clinica IVRS/IWS)
• Data integration links (central lab, central readers)
• Study management tools
  • Study tailored downloadable reports
  • Reminders, announcements and alerts
  • On-line study documents
• Data transfer in accordance with client standards
• 24/7 Help desk
• GCP and FDA 21 CFR part 11 compliant

Key benefits:

• Easy of use
  • Easy navigation
  • Intuitive data capture
  • Investigative site minded
• Powerful user assistance through automated processes
  • Suppresses repetitive and depressive work
  • Cost and time efficient
• No installation needed