Release Schedule

Sneak Preview

The 26.3.0 release will bring exciting new enhancements to elluminate, and we're giving you an early look at what's to come. This sneak preview highlights the major features in active development, aimed at improving both the intuitiveness and power of your experience. This is not a full list of all the capabilities to come. Stay tuned for more details as we finalize these updates!

Data Central

New! Visualization Types

Data Central visualizations will expand with four new chart types: Gauge, Funnel, Sankey, and Donut (Pie setting). These additional visualization options will provide more flexibility in how study data can be presented and explored, including progress toward targets, sequential processes, flows between categories, and proportional distributions.

Update! Support for Multiple Visualization Filters

Users will be able to make selections across multiple visualizations while retaining filters already applied from other charts, allowing them to progressively refine their analysis across the workspace.

New! Create Issues from Visualizations

Users will be able to create domain-, record-, and field-level issues directly from Data Central visualizations, allowing potential concerns identified during visual analysis to be captured and tracked without navigating away from the chart. Issue creation will carry relevant context from the selected visualization or data point into the issue, helping users move more seamlessly from analysis to investigation and action.

Orchestrator

New! Create Orchestrator Rules from Exception Listings

Users will be able to create Orchestrator Rules directly from existing Mapper and SCE Exception Listings, eliminating the need to recreate existing exception logic in Condition Builder or SQL. The resulting rules will use the exception listing output to automatically create issues or queries for applicable records, providing a more direct path from identifying exceptions to automating downstream review actions.

Issues

New! Issues Overview Workspace

A new Issues Overview workspace will provide a centralized, high-level view of issues across a study. New visualizations will help users understand issue distribution and status, identify concentrations across sites and subjects, and monitor overdue and upcoming issues, with the Issues panel available alongside the analyses for further investigation.

Risk Management

New! AI-Assisted Risk Suggestions

A new AI-assisted capability will be introduced in RACT to accelerate risk assessment setup using protocol-driven insights. RACT will generate suggested risks for an assessment based on the study protocol, the configured Risk Library, and risks already documented, with supporting context to help reviewers evaluate each suggestion. Reviewers will retain full authority over every outcome, accepting or dismissing suggestions as part of their existing assessment workflow. The feature will reduce the manual effort of locating and documenting risks across lengthy protocols while supporting consistency and traceability in risk assessment.

New! Risk Profile Export

A new PDF export option will be available in RACT that presents each risk on its own page, alongside a study overview and a summary of the Critical to Quality Factors assessed. This format will make it easier to review and share individual risks in a readable, standalone layout, complementing the existing register-style exports.

New! User Selection for Risk and Monitoring Owners

Risk Assessments will support a new user selection field type, enabling risk owners, monitoring owners, and other custom-defined responsibilities to be assigned to named elluminate users rather than entered as free text. This update will provide more structured and consistent ownership documentation, reflected across Risk Assessment analytics and the Study Risk Management Plan export.

New! A More Connected Risk Signal Workflow: From Raising a Signal to Tracing It Back in Time

Users will be able to raise a Risk Signal or Issue directly from the KRI Details panel, with the Category automatically populated from the associated KRI or QTL. Users will also be able to link Risk Signals directly to a Risk from the RACT assessment, connecting observed signals to the risks already being tracked.

When reviewing a signal from a previous run, the RBQM Snapshot date will become a hyperlink that takes users directly to the Overview as it appeared for that run, with the corresponding row highlighted.

In addition, KRI trend tooltips will display open and closed signal counts for each run, with links to the filtered Risk Signals records, making it easier to trace signals over time and support audit-ready root cause analysis.

New! Risk Signals Tab Under the Overview KRI Details Panel

A new Risk Signals tab will be added to the KRI Details panel, providing a consolidated view of risk signals associated with a specific KRI for a selected site or country.

The tab will display the number of open and closed signals, alerts, and issues, along with charts showing signal type, response rate, and open-to-close rate.

A hyperlink will also allow users to navigate directly to the Risk Signals grid, automatically filtered to display the corresponding risk signals.

Update! Refreshed RACT Appearance

RACT will receive a refreshed appearance, spanning the assessment view and the Analytics dashboards. The update will introduce a lighter, more scannable layout and bring consistency across the Risk Management experience.

Update! Version Comparison Aligned with the Study Risk Management Plan

The Version Comparison report in RACT will be updated to reflect the same fields, structure, and terminology used in the Study Risk Management Plan report. This alignment will ensure that on-screen comparisons of assessment versions match what is delivered in exported reports, making it easier to review changes between versions with confidence.

Update! Version-Specific Change History for Reassessments

Version History in Risk Assessments will be redesigned so that each reassessment carries its own record of the description of and reason for the change, preserved alongside the version it describes. Documentation from prior versions will be carried forward and protected from edits, and the full history will be included in the Study Risk Management Plan exports, supporting traceability for compliance and review.

Update! Risk Signals Overview Dashboard

Users will be able to view open vs. closed signals by Level or KRI, track Average Signal Response Rate or Open-to-Close Rate trends over time, and use shared Category, Type, and Level filters to update all dashboard charts at once.

Update! Custom KRI Root Cause Analysis

Custom KRI supporting graphs will automatically filter to the site or country being investigated, giving central monitors more relevant context for root cause analysis. Users will be able to add and switch between multiple visualizations and adjust charts on the fly to explore the data from different perspectives.

Update! Retirement of RBQM Legacy Screens

The legacy KRI, Site Details, and Country Details pages will be retired, and their associated navigation links will be updated. This will streamline the RBQM experience by providing users with one clear place for each monitoring task and eliminating duplicate or outdated workflows.

SCE

New! Copy from eDrive to SCE

Users will be able to copy files from eDrive directly into an SCE folder, using a new action in the Browser toolbar or in a folder’s context menu in the Browser or Editor. After choosing a source (a study or Global), users will be able to browse its dated imports, search for files by name, and select the files to copy. Blinded files will remain visible but will only be selectable by users with the Blinded Data View privilege, and copied blinded files will remain access-restricted. Destination folders will respect each user’s existing SCE permissions, and name collisions will be resolved automatically. After the copy, SCE will confirm the result, open the destination folder, and record the operation in the audit log.

New! Copy from Data Store to SCE

Users will be able to copy datasets from a study’s data stores into an SCE folder without leaving SCE. Users will be able to browse the data stores they have access to, select individual datasets or whole data stores, and choose an output format of .sas7bdat (default), .csv, or .xlsx. Blinding will be handled automatically based on the user’s privileges. Users without the Blinded Data View privilege will receive masked values and no decision will be required. Users with the privilege will be able to choose between copying unblinded data, which will remain access-restricted, or copying masked data that anyone can access.

New! Native Dataset Viewer for SAS7BDAT and XPT Files

Users will be able to open SAS7BDAT and XPT files stored in the SCE file system and view their full contents in a grid within SCE, without launching SAS Studio just to inspect a dataset. The viewer will support sorting, jumping to any page, and a metadata view of column details. A row-number column will make it easier to match a record flagged in QC output, such as a PROC COMPARE observation number, to the data. The file Properties panel will also show row and column counts and additional reader-provided attributes, such as dataset and column labels.

New! Safer Shiny Development in RStudio

Shiny app developers will be able to run and test apps in RStudio with live access to the SCE file system and Data Store, without publishing first. Access will use the developer’s own elluminate credentials, so the same role, study-level, and blinding rules will apply as for a published app. Publishing and deployment will move exclusively to SCE, and RStudio’s publish and deploy options will be removed and blocked server-side.

New! Delete Development Apps from the Applications Grid

Apps Hub Developers and Publishers will be able to delete apps in Development status from the Applications grid, allowing them to remove drafts, tests, and abandoned apps. A confirmation dialog will identify the app and warn that the action cannot be undone. When a Published version exists, it will not be affected, and Revert will become available on it so development can resume from the published baseline. Deletions will be recorded in the audit trail.