EDC

CIMS Global's Electronic Data Capture (EDC) solution delivers a comprehensive suite of clinical data management capabilities designed for life sciences organizations running clinical trials. The platform covers the full spectrum of data management activities, including eCRF design and build, study setup, edit check creation, query management, unscheduled form additions, and source document verification (SDV). Natively integrated with the CIMS eClinical Suite, the EDC provides end-to-end software support across the entire clinical trial lifecycle.

CIMS EDC is built for clinical data managers, investigators, and site staff who require an intuitive, flexible, and regulatory-compliant system to capture, monitor, and report trial data efficiently. Its device-optimized interface and deep integration capabilities make it suitable for both simple and complex multi-center studies.

Key Features

• Quick Builds: Clinical databases and edit checks can be constructed rapidly using an efficient, streamlined workflow, reducing setup time and accelerating study start-up.
• Intuitive User Interface: Status bars with unique two-dimensional features enable easy drill-down to individual data points. The built-in query management system handles query release and resolution with a comprehensive audit trail. The interface is fully optimized for use on any device.
• Risk-Based Monitoring: The system can be configured to support either 100% Source Data Verification (SDV) or risk-based monitoring, with monitoring intensity determined by a predefined risk score tailored to study requirements.
• Flexibility and Integration: CIMS EDC integrates natively with other CIMS products, including RTMS, eSafety, Encoder, and DDM™, enabling comprehensive study support and streamlining data collection, integrity, and traceability across the eClinical Suite.
• Custom Reporting: The platform provides a range of customizable reports, including progress reports by center or investigator, query status reports, adverse event (AE) reports, individual subject profiles, and population-based data displays.
• Built-In SDTM Mapper: CIMS EDC includes a unique, built-in SDTM mapper that maps and generates SDTM databases complete with annotated CRFs and define files, simplifying regulatory submission preparation.

Query Management Capabilities

• Comprehensive query release and resolution workflows are managed directly within the EDC interface.
• A full audit trail is maintained for all query activity, supporting data integrity and regulatory compliance.
• Unscheduled forms can be added flexibly throughout the study, accommodating real-world clinical trial complexity.

Source Document Verification

• Efficient SDV tools are built into the platform to support site monitoring activities.
• Configurable monitoring approaches allow sponsors and CROs to apply either full SDV or targeted risk-based monitoring strategies based on study-specific risk scores.

CIMS EDC is part of the broader CIMS eClinical Suite, providing seamless interoperability with complementary modules for safety, randomization, coding, and data management. This native integration supports a unified, traceable data environment across all stages of a clinical trial.