S-EDC

S-EDC, developed by S-Clinica, is an Electronic Data Capture (EDC) solution specifically designed for clinical trials. According to the vendor, this platform is suitable for pharmaceutical companies, biotechnology firms, and contract research organizations (CROs) of all sizes. It is widely used by clinical research professionals, data managers, clinical operations managers, biostatisticians, and professionals in the pharmaceutical and biotechnology industries for efficiently capturing, managing, and monitoring clinical trial data.

Key Features

Clinical Data Capture: According to the vendor, S-EDC offers a robust and user-friendly platform for electronically capturing clinical trial data. It supports various methods of data entry, including web-based forms, electronic case report forms (eCRFs), and mobile devices, allowing for efficient data collection, management, and monitoring throughout the trial.

Data Validation and Quality Control: The vendor claims that S-EDC provides comprehensive data validation features to ensure the accuracy and integrity of the collected data. It allows users to create custom edit checks and validation rules, enabling real-time data validation during data entry to prevent errors and inconsistencies. The system also supports data reconciliation and discrepancy management to identify and resolve any data discrepancies.

Electronic Signatures and Audit Trail: According to the vendor, S-EDC enables electronic signatures for data entry, review, and approval, ensuring compliance with regulatory requirements for electronic records and signatures. The system maintains a detailed audit trail of all data changes, capturing user actions, timestamps, and the reasons for the changes, ensuring data traceability and accountability.

Data Export and Reporting: The vendor states that S-EDC allows for easy data export in various formats, including CSV, Excel, and PDF. It offers customizable reporting capabilities, enabling users to generate ad hoc reports and custom queries. The system supports data visualization tools and dashboards for real-time data analysis and monitoring. Additionally, it facilitates data integration with other systems and databases for further analysis and reporting.

User Management and Permissions: According to the vendor, S-EDC provides robust user management features, allowing administrators to create and manage user accounts. It supports role-based access control, ensuring that users have appropriate permissions based on their roles and responsibilities. The system also allows for the customization of user interfaces and data entry forms based on user preferences. Furthermore, it provides user training and support resources to ensure efficient system utilization.

Data Security and Compliance: The vendor emphasizes that S-EDC prioritizes data security and compliance with industry standards and regulations. The system utilizes secure data transmission protocols and encryption to protect sensitive data. It ensures compliance with regulations such as HIPAA, GDPR, and 21 CFR Part 11. Regular security audits and assessments are conducted to maintain the highest level of data security.

Integration and Interoperability: According to the vendor, S-EDC supports seamless integration with other clinical trial systems, such as electronic health records (EHRs) and laboratory information management systems (LIMS). It enables data exchange through standardized formats and APIs, ensuring interoperability with external systems. The system also facilitates data import from external sources, such as electronic data capture (EDC) systems and electronic source data (eSource) systems, allowing for comprehensive data analysis and reporting.