Data Central

Data Central, part of the elluminate Clinical Data Cloud, is an integrated clinical data management and review platform designed for data managers, medical monitors, clinical scientists, and clinical operations teams across biotech, pharma, and CRO organizations. Now powered by agentic AI, Data Central brings together all trial data from any source into a single, centralized system — eliminating the need to navigate multiple disparate tools, spreadsheets, and listings to manage and review study data.

By centralizing data review and management workflows, Data Central enables teams to produce high-quality databases more efficiently, resolve queries faster, and maintain greater visibility into study progress. The platform is system agnostic, capable of ingesting and aggregating data from any source regardless of file type or system, and can be initially configured within a matter of days.

AI-Enabled Data Review with eIQ Review

• Seamlessly integrated with Data Central, eIQ Review provides AI-enabled review capabilities for data managers and reviewers
• Automatically prioritizes urgent issues and flags anomalies to improve data quality and reduce manual effort
• Increases the speed of review and supports data integrity in a more efficient, scalable way

Integrated Data Review and Query Management

• Raise and process EDC queries directly within Data Central using intelligent prioritization
• Review CRF data, listings, exception reports, and patient profiles in one unified environment
• Quickly identify data changed since the last review by role, enabling targeted re-review
• Data managers and medical reviewers collaborate within the same system to resolve queries and data issues without switching between platforms
• Once reviewed, data does not reappear unless it has been changed or new data has been added, streamlining the review process

Actionable AI Analytics for Improved Data Quality

• Analytics facilitate targeted data reviews based on roles and automatically highlight areas needing attention, such as long-outstanding queries
• Drill down to source data and raise issues directly from within visualizations
• Create and access customizable graphical patient profiles including single and ongoing events, lab data, and more
• Embedded AI agents help users understand and explore data more efficiently
• Centralizing analytics eliminates the need to create and distribute multiple data exports, reducing the risk of introducing errors

Role-Based Review for Effective Data Management

• Provides a single role-based clinical data management system for integrated data review across the study team
• Offers a holistic view of study data, query, and issue statuses for earlier insight into potential problem areas
• Review data and listings according to individual role within the platform
• Track records reviewed by role and records updated since the last review
• Monitor and track issues by due date, assignee, site, subject, data domain, and more with AI-driven risk prioritization

Patient Profiles and Listing Capabilities

• Graphical and Excel-based patient profiles are immediately available following initial configuration
• Users can create custom graphical patient profiles for personal use or to share with team members
• Access robust pre-programmed listings, patient profiles, and visualizations within the system
• Listings can be configured to require review from a particular user, role, or number of users
• Comments and queries are visible to all relevant users, preventing duplicate efforts

Deployment and Configuration

• Initial configuration can be completed within a matter of days; features such as graphical patient profiles or exception listings may take a few additional weeks to populate
• Data refreshes are fully configurable, and users can export data on an ad hoc basis depending on system permissions
• Benefits both insourced and outsourced models, supporting more efficient resource management and greater oversight of CRO or third-party activities

Data Central is fully compliant with 21 CFR Part 11 and ensures data privacy and security in accordance with global regulatory requirements. Audit trail reports can be accessed within the system or exported for inclusion in trial master files or other documentation. The platform integrates with other elluminate modules including eIQ Review, Risk-Based Quality Management, and Clinical Analytics, providing a comprehensive, connected environment for modern clinical data operations.