Release Schedule

Release Guide Video Series

This series demos the whole release and every release note ticket, meaning every new feature, update, and enhancement released in elluminate 25.1. It aligns with the release notes, so you can skip to the sections and issue numbers you're interested in, and includes links to related micromodules. The entire series is just under an hour in duration. To skip a video and watch another, use the playlist navigation to the right of the video.

Tip: Each video demos every update, but we also offer step-by-step interactive micomodules on select updates with each release. To access those trainings, click the links when they appear on the screen while watching the video or select from the list below.

Release Guide Training Micromodules

• Platform: Configure Clario eCOA Data Sources
• Platform: Configure SAS LSAF Data Sources
• Issues: Create and Defer Issue Notifications
• Data Central Pie and Combo Chart Visualizations: Custom Color Selection
• Protocol Deviations: Bulk Editing

Release Highlights Summary

Analytics

New! Missing or Delayed Samples Sheet in SMA. Quickly identify potential sample delays or misplacements with the new Missing or Delayed Samples sheet. Color-coded by status, this sheet highlights samples that exceed user-defined thresholds for Days At Site, In Transit, or At Lab. The data can be easily filtered across multiple dimensions and is displayed in both graphical and tabular formats for clear insights and analysis.

Updated! Enhanced Integration and Usability of Protocol Deviations sheets in CTOA. To support elluminate’s new Protocol Deviations module, the CTOA app has been enhanced to work seamlessly with studies using this new data source, while still supporting studies that rely on external sources, ensuring consistent integration and streamlined configuration across all use cases. Updates span both the Protocol Deviations – Overview and Protocol Deviation Details sheets, with a focus on improving usability, flexibility, and data analysis.

Updated! Added support for Subject-Level AESIs in CDA. CDA now supports both study-level and subject-level AESI (Adverse Events of Special Interest) criteria, allowing for more flexible and granular handling of AESI data across studies.

Updated! Redesigned the Demographics sheet in CDA. The Demographics sheet has been redesigned to improve usability, reduce redundancy, and enhance data visualization. A new unified control now lets users select Country, Site, Group Assignment, Sex, Race, or Ethnicity, with all visualizations dynamically responding to the selected variable. Chart types and layout have been refined for clearer comparisons and a more streamlined, intuitive analysis experience.

Updated! Added support for all Disposition Event Categories on the Disposition sheet in CDA. The Disposition Summary sheet has been updated to provide more flexible and transparent analysis of all disposition event categories. The chart, pivot table, and data table now dynamically update based on the selected category—ensuring no data is excluded by default.

Data Central

New! Integrated Data Review Plan (IDRP). Users can now build, manage, and execute Review Plans entirely within elluminate, starting in the new Review Plan tab in Data Central Configuration. Define Review Objectives with key attributes like Primary/Secondary Domains, Reviewer Roles, Priority, and Review Frequencies, and seamlessly link relevant review materials such as listings, visualizations, workspaces, Analytics apps, and RBQM dashboards.

Once configured, reviews can be tracked and executed in a dedicated Review Plan section within Data Central. This guided workflow ensures reviewers always know what needs attention and can access all supporting materials with a single click.

Visualize progress using dashboards and panels that break down objective completion by domain, priority, and reviewer role—with both role-specific and cross-role views available.

Use Excel import/export tools and templates for bulk setup, and rely on comprehensive audit logs for full traceability across all configuration and review actions.

Updated! New Issues Related Fields tab added to Domain Settings. A new Issue Related Fields tab has been added to Domain Settings in Listings, allowing users to configure a list of fields to be automatically associated with Issues created within each domain. These related fields are displayed in the Issue Details panel and the Related Fields column in Global Issues.

Updated! Data Central Visualizations now support custom colors for Pie and Combo Charts. Users can now assign custom colors to each segment in Pie and Combo charts, including values in Dynamic Dimensions to highlight important data, reinforce meaning, or apply brand-aligned color palettes.

elluminate Assist

Updated! elluminate Assist Expanded Capabilities. elluminate Assist now features an updated toolbar with a More icon for new chats or to view chat histories, a Pin icon to keep the window open, and a Maximize icon for full-screen viewing. The underlying model has also been enhanced to improve performance.

Operational Data Repository (ODR)

New! Data Model for Operational Data (DMOD) Standard. DMOD is an eCS-built standard data model designed for Operational Data. Built upon the original ODR (Operational Data Repository) structure with significant expansions, DMOD maximizes coverage of Operational Data elements, addressing the needs of Clinical Trial Operations.

Available within the Standards module, DMOD enables efficient versioning management and allows users to create and customize their own data models, ensuring flexibility and scalability for handling clinical trial data in a structured and adaptable manner.

DMOD can be used similarly to other Standards models with any data store and can be selected in a Mapping and used within Validator.

Updated! Configuration items available for custom field Picklists. In Fields Config, elluminate Configuration items (Therapeutic Areas, Investigational Products, Programs, Phases, Study Type, Endpoints, Controls, Blindings) can be assigned to Picklists for custom fields, allowing seamless integration within ODR forms.

Updated! Customize ODR Grid Visibility for OOTB fields. The ODR grid can now be customized by enabling or disabling the visibility of top-level out-of-the-box fields within Fields Configuration.

Updated! Expanded ODR Export Capabilities. In addition to exporting data through the Exporter module, users now have the option to export the filtered grid data to Excel.

Orchestrator

Updated! Enhanced visibility for Orchestrator-generated Issues and Queries. The 'Opened By' column in Issues and Queries listings now displays the full name of the Orchestrator rule that created them. Filtering by Orchestrator rule is also now available for easier rule-based reviews.

Platform

New! Clario eCOA Clinical Trial Data API connection. Users can now import data from the Clario eCOA Clinical Trial platform, including Subject data, Subject activation and continuation, any data recorded in the Clario system, as well as valuable system information like audit logs and metadata.

New! SAS Life Science Analytics Framework (LSAF) API connection. Users can now import data stored in the SAS LSAF platform, allowing the ingestion of data files contained within repositories configured in the LSAF platform.

Risk Management (RACT & RBQM)

The risk-management suite has been rebuilt end-to-end to provide a faster, clearer, and more connected experience while staying fully aligned with ICH E6(R3).

Updated! Redesigned RACT. The RACT workflow and assessment process have been overhauled to align with modern UI standards, improving customization and enhancing adaptability for diverse industry practices.

Updated! Redesigned RBQM. The RBQM updates are designed to simplify risk monitoring, improve visibility, and enhance the overall efficiency of your quality management processes. The improved RBQM dashboards feature an enhanced interface layout, offering better visibility and a more intuitive presentation of key metrics.

New! Risk Management page. The Risk Management page is introduced to provide centralized access to all RBQM and RACT-related studies, featuring study overviews, and quick actions, such as running the RBQM Engine and starting a new assessment directly from the page.

Updated! Risk Management Configurations. All RACT configurations are now managed from one place and seamlessly shared with RBQM for improved consistency.

New! Risk Library. The Risk Library allows users to document, manage, and import risks for easier integration into risk assessments. It also comes with out-of-the-box recommended mitigations and monitoring metrics to support effective risk management strategies.

New! AI-Powered Risk Statement Generation. A new AI-powered Risk Statement generation tool has been added to RACT to help users generate risk statements ('if - due to - then' fields) more accurately and efficiently.

New! Risk Management Plans. Customized Risk Management Plans can now be generated in Excel or PDF formats to facilitate risk assessment and risk mitigation documentation.

New! RACT Reassessment Reminder. To help teams stay proactive, RACT reassessment intervals and due date reminders can be set up within the elluminate.

Statistical Computing Environment (SCE)

New! Ability to create Domain Issues. SCE users can now create and manage data Issues directly on study datasets within the Statistical Computing Environment. This new capability enables programming teams to document abnormalities and route Issues to relevant users or groups, streamlining collaboration with data management teams. Previously, Domain Issues were managed exclusively in Data Central. Now SCE users can initiate Issue workflows without switching contexts, eliminating the need for external tracking methods and improving cross-team communication. All Issues raised in SCE are logged in the Issues module for full traceability.

Download Full Release Notes

• elluminate 25.1.0 Release Notes.pdf400 KB