eCaseLink EDC/DDC

eCaseLink EDC/DDC is an Electronic Data Capture platform developed by DSG, designed for use in decentralized and traditional clinical trials. It supports the collection of clinical trial data in electronic format (eCRF) for FDA submission, and is intended for study managers, CRAs, site users, clinical operations teams, and sponsors running trials of any size or complexity.

The platform is positioned as a unified solution that covers the full clinical trial lifecycle, either as a single integrated system or as modular components that can be combined with other tools. It includes additional modules for eConsent, eCOA, and RTSm, and is built to operate without requiring programming knowledge from its users.

Core EDC Features

• Guided workflow designed for ease of use across user roles
• Rapid study setup and deployment, including support for multiple third-party data integrations averaging eight weeks for system development
• Full-service and self-service options available
• Supports mobile use, including eSource and home visit data collection
• Supports remote source data verification (SDV)
• Supports complex study designs
• Delivered with project management support
• Part of a broader unified product suite including eConsent, eCOA, and RTSm

Instant Validation and Data Quality

• Proprietary field-by-field validation occurs instantly without connecting to the server or requiring client plug-ins
• Instant validation reduces the number of form resubmissions and the volume of data requiring post-submission queries
• Page-based technology allows each saved page to represent clean, validated data
• Library eCRFs can be saved and reused across studies to accelerate future trial setup

Data Integration and eSourcing

• Integrates and manages data from multiple industry sources within a single database
• Supported data sources include core and central laboratories, specialty laboratory data, IVRS, CTMS, ECG, CT scans and MRIs, topographies and radiographics, EMR, medical device output, and safety data
• Convenient dashboards for viewing and accessing integrated data

Reporting and Data Access

• More than 40 standard reports available out of the box
• Library of configurable standard reports, as well as custom and ad-hoc reporting
• On-demand data exports and full ad-hoc reporting for real-time data access and management
• Datasets on demand provided as a standard feature

User Interface and Site Acceptance

• SmartLinks technology automatically adjusts the user interface based on each user's individual workflow patterns
• Proprietary dashboard accessible from any screen, providing a snapshot of queries, saved eCRFs, and enrollment
• Interactive report library accessible at any time from within the platform
• Highly configurable and flexible to adapt to individual user workflows

Multi-Language and Global Support

• Supports Japanese, Chinese, and Western European languages
• Allows sponsors to operate a single global platform without installing separate language versions
• Data managers and clinicians can collaborate using a single centrally managed global database regardless of geographic location or language
• 24/7/365 global technical support provided for all client deployments

Protocol and Study Management

• Protocol amendments and mid-study changes can be implemented without system downtime
• Local lab management system enables data managers to manage local labs and normal lab ranges, with interactive review of laboratory data
• Dynamic software integration supported as a standard feature

Additional Modules

• Protocol Deviations: CRAs, site users (if requested), and clinical operations teams can create protocol deviations at both participant and site level; includes review and query workflows allowing clinical operations or medical monitors to request corrections and clarifications from CRAs
• CaseXPort: Generates an FDA-compliant, site-specific electronic archive PDF containing all eCRFs used in a study, bookmarked and hyperlinked with an audit trail, for submission within the eTMF to satisfy records retention requirements at each site

eCaseLink is delivered as a cloud-based platform with no client plug-ins required, and pricing is described as straightforward and cost-effective regardless of study size. The system supports both decentralized and traditional trial models and is designed to integrate with a wide range of third-party clinical data systems.