EDC

Clincase EDC is an electronic data capture and clinical data management solution designed for use in Phase I–IV clinical trials. It is used by pharmaceutical and biotech companies, CROs, research centers, and university hospitals across Europe, the United States, and Asia. The platform has been deployed in over 400 studies and has documented data for more than 100,000 subjects.

Clincase supports the full range of clinical trial data management activities, from eCRF design and data collection through to monitoring, reporting, and data extraction. It is built to meet regulatory requirements including ICH GCP, HIPAA, FDA 21 CFR Part 11, EMA, NMPA, and PMDA standards.

Core EDC and Data Collection Features

• Flexible eCRF design with a drag-and-drop form builder and a scripting language for advanced configuration
• Integrated ePRO questionnaires for patient-reported outcome data collection within the same system
• Real-time calculations and field dependencies handled automatically
• Automatic data saving when leaving a field, removing the need for manual saves
• Edit Checks feature for simplified query management
• Support for mapping various trial types and page structures
• Forms can be organized to build an intuitive eCRF structure

Workflow and User Role Guidance

• Role-based guided workflow directs users to their next required action
• Investigators are guided to sign data, resolve queries, or complete missing data entries
• Monitors are directed to perform source data verification (SDV) or selective/targeted SDV
• Data managers are guided to review data, close queries, and visualize key data for the clinical team
• Flags, comments, and queries support collaborative study workflows

Electronic Signatures and Audit Trail

• Electronic signatures compliant with FDA 21 CFR Part 11
• Signature fields can be defined at different levels in the study metadata, with associated roles and meanings
• Password authentication required for any signature changes
• Complete audit trail tracking all data modifications and user actions at various levels

Monitoring and Risk-Based Management

• Real-time data and SDV flagging workflows to support risk-based monitoring (RBM)
• Online data preview and chart visualization of key metrics
• Over 50 standard reports available out of the box
• Data visualization tools for reporting and analysis

Configuration and Study Amendments

• Configurable to support individual study requirements, including electronic signatures, data export formats, and task and workflow assignments to user groups
• Protocol amendments and eCRF changes can be implemented in a controlled manner without significant time delays
• Accessible from multiple devices and locations via internet connection

Integrated Modules and Additional Capabilities

• Optional ePRO solution integrated with EDC
• eLearning module for user training
• AE/SAE notifications
• IWRS and supply management
• PDF creation of complete eCRF copies including audit trail, queries, and workflow flags
• User management with flexible control over visibility and access
• Data export in configurable formats

Clincase EDC is a web-based platform accessible across devices and locations. It is designed to integrate its modules natively with the EDC system, avoiding the need for separate data import or export between components. The platform is positioned for use by organizations of varying sizes conducting regulated clinical research globally.