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 25.2. 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 micromodules 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: Export and Import ETL Configuration
• Platform: Export and Import DMT Configuration
• Platform: Export and Import Blinding Configuration

Release Highlights Summary

Analytics

Analytics includes several enhancements that improve flexibility and consistency across CDA, CTOA, SMA, and OO.

• All Apps - Hide Out-of-the-Box Base Sheets: CDA, CTOA, SMA, and OO now support hiding selected or all out-of-the-box sheets, allowing organizations to display only the sheets relevant to their users. Base sheet hiding must be done through eCS Support so Engineering can apply the configuration.
• CTOA, SMA, & OO - User-Group Sheet-Level Access Control: CTOA, SMA, and OO now support role-based sheet visibility, allowing organizations to control which sheets users can access through elluminate user-groups. Sheet-level control must be done through eCS Support so Engineering can apply the configuration.
• CTOA - Support for Study-Level Planned Enrollment: CTOA now supports study-level planned enrollment across all enrollment dashboards, ensuring values are displayed correctly whether defined at the study level or more granular levels.
• SMA - Externalized Anomaly-Detection Rules: SMA now supports externalized anomaly-detection rules, allowing organizations to define their own criteria for identifying potential issues in the Data Anomalies sheet. Custom rules must be done through eCS Support so Engineering can apply the configuration.

Data Central

Data Central and Data Central Configuration now offer expanded capabilities to support the Integrated Data Review Plan (IDRP), deepening integration across modules and strengthening alignment, collaboration, and oversight throughout the data review process.

• RACT Integration: Users can now link Review Objectives to risks from the latest finalized Risk Assessment in RACT, reinforcing prioritization and alignment with study risks.
• Approval & Versioning: A new versioning workflow introduces structured version control for Review Objectives. Approved objectives become read-only and require versioning before modification. A Version History panel allows users to compare versions side-by-side and view highlighted changes.
• Configuration Collaboration: A new Comments & Activity panel is available when configuring each version of a review objective, capturing comments and status transitions. Users can also @-mention collaborators to trigger email notifications with direct links, improving communication and follow-up.
• Bulk Editing: A new Bulk Edit grid allows users to update multiple Review Objectives at once using an editable spreadsheet-style interface. Users can copy and paste values, edit directly in cells, and validate changes before saving.
• Global Library Integration: Users can now import Review Objectives from the Global Library or promote approved Review Objectives to the Global Library for reuse across studies, improving configuration efficiency and consistency.
• Review Cycle Oversight: A new Review Cycles sheet has been added to the Review Plan Dashboard, providing cycle-level visibility into completion status across Review Objectives. Interactive charts, a comprehensive Review Cycles listing, and a new Missed status help teams track timeliness, accountability, and review performance across roles.
• Notification Integration: Reviewer Roles can now be configured to receive automated email notifications for key Review Objective events, including submissions, approvals, rejections, reminders, and missed review cycles, ensuring timely visibility and strengthening proactive review management.

These enhancements improve transparency, control, and efficiency in the data review process.

Protocol Deviations Enhancements

The Protocol Deviations Dashboard has been enhanced to provide a more consistent user experience with other panels in Data Central. New functionality includes exporting Protocol Deviation data from the dashboard, setting user domain preferences for field hiding, clicking and dragging columns to rearrange them, and exposing Protocol Deviation data for Data Central Visualization development supported by eCS representatives.

Veeva CDMS Query Connector Enhancements

The capabilities of the Veeva CDMS bi-directional query connector have been expanded in this release. Functions previously unavailable through Veeva’s API are now supported, including:

• Ingesting Event or visit-level queries through the Importer
• Displaying, creating, or acting on Event queries in Data Central
• Reopening Veeva CDMS queries that are in a closed status
• Providing improved access to source data from Query records in Data Central

Platform

Expanding Configuration Migration Capabilities

Several elluminate configurations have been enhanced to allow users to extract completed configurations from their studies or URLs and migrate them to other studies or URLs as needed. This eliminates the need to reconfigure the modules listed below:

• Orchestrator Rules (additional migration support coming shortly after release)
• Blinding Configuration
• Validator
• Dynamic Mapping Templates
• Study ETL Keys

Risk Management

Key enhancements across Risk Management Configuration, RACT, and RBQM improve alignment, usability, and traceability throughout the risk assessment and monitoring process. Highlights include:

• Improved linkage between Risks and Review Objectives with new Review Plan indicators, warnings for linked risk deletions, and tighter integration with the Integrated Data Review Plan.
• More intuitive RACT workflows, including prioritized Risk suggestions based on CTQs and redesigned Risk tracking and identification screens.
• Updated navigation in RBQM and RACT with a new left navigation panel, consistent layout, and smoother movement between related areas.
• Streamlined RBQM configuration with direct linkage to CTQs, QTLs, and KRIs from Risk Management Configuration and improved synchronization and audit traceability.
• Enhanced RBQM monitoring visibility through timestamped Snapshots and new KRI side-panel details in Sites and Countries Overview.
• Support for versioned Assessment Settings for managing multiple RACT configurations across programs and studies.

Mapping Automation (coming shortly after release)

Specification Generation

elluminate will provide accelerators for automated SDTM transformations. The process will begin with AI-powered variable matching, where source variables are automatically aligned with the most appropriate SDTM targets using SDTM Implementation Guide knowledge, natural language processing of variable metadata, and historical mapping patterns. Building on this foundation, an agentic AI approach will then evaluate each source-target pairing to determine the appropriate transformation logic. The agent will experiment with combinations from a library of standard transformation functions, validate results against the source data and expected sample SDTM outputs, and select the optimal approach, which will be returned for user evaluation.

The output will be a structured, human-readable specification that includes both the suggested variable alignments and transformation functions. By automating specification creation, elluminate will reduce manual effort, accelerate one of the most time-intensive steps in preparing clinical trial data for standardization and submission, and maintain full transparency for expert human oversight and control.

Code Generation

Once specifications are finalized, elluminate will convert structured specifications into executable Python or R code using a library of validated algorithms. Each domain operation and variable transformation will be translated to code by validated deterministic functions, ensuring consistency and reproducibility. The generated code will be fully transparent, allowing users to review, refine, and supplement programming logic as needed.

Generated mapping programs will execute directly within elluminate Compute Environment as part of an automated pipeline, triggered by data refresh and integrated with downstream workflows. Execution will produce complete logs and outputs, maintaining full traceability from specification through runtime. For the most complex derivations, generated code can be edited and extended using established programming PDLC practices, allowing programmers to augment the automation with their specialized expertise. By automating routine transformations while enabling human oversight and intervention for edge cases, elluminate will allow teams to maximize the value of their programming resources, reduce manual effort, and streamline the production of submission-ready datasets.

Download Release Notes

• elluminate 25.2.0 Release Notes.pdf400 KB