S-EDC

S-Clinica's S-EDC is a user-friendly, web-based solution that integrates all aspects of remote data collection, data management, patient monitoring and ongoing analysis within one robust system.

S-EDC, the S-Clinica electronic data capture (EDC) 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 randomisation 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

e-CRF 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 check 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
• Improve 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 FDA21 CFR part 11 compliant.

Key benefits

Easy 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.