Added REST API endpoints to support System for Cross-domain Identity Management (SCIM)-compliant integrations in elluminate. These endpoints enable external identity management platforms to manage users and predefined user groups.

Supported user actions include:

• Provision user
• Deprovision user
• Update user

Supported user group actions include:

• Retrieve groups
• Create groups
• Update group, including user assignment

This update enables organizations to manage users externally through identity management platforms and control platform access through user authentication and group-based privilege assignment.

Added support for integrations with System for Cross-domain Identity Management (SCIM)-compliant platforms for automated user provisioning and deprovisioning through external identity providers such as Azure Entra ID and Okta in elluminate.

This allows organizations to manage user access through existing identity systems, reducing manual administration and improving consistency when provisioning or deprovisioning user accounts and assigning users to predefined user groups using REST API endpoints.

Added support OAuth2 OIDC for single sign-on authentication in elluminate. This update expands SSO configuration options beyond SAML and enables integration with a broader range of external identity providers.

Users can now work with eCS Administrators and IT personnel to provide required parameters and configure OAuth2 OIDC connections between identity access management platforms and elluminate.

Updated the Add / Edit Review Objective window to include a ‘Show Relevant Only’ radio button within review material selectors, allowing users to filter Data Central Listings, Visualizations, eIQ Review Models, and Orchestrator Rules based on the selected Primary Domain, Secondary Domains, Fields, and Review Objective description. When selected, the drop-down displays the most relevant materials while allowing users to toggle back to the full list without losing selections. 

This enhancement reduces manual searching, simplifies configuration, and helps users easily identify and select the most appropriate review materials.

Data Central now retains personalized column layouts and widths in Subjects, Issues, Queries, Data Listings, and Records Review Summary panels per user and per listing, even after refreshing, navigating away, or logging back in. This reduces repetitive setup and helps maintain a consistent, workflow-specific view during data review. Saved preferences are retained even if columns are removed. 

To reset column visibility, order, and width to system defaults, select the gear icon in the panel toolbar to access Domain Settings, then click Restore Default Variable Settings.

Users can now link Review Materials directly to Review Objectives within Data Central, eliminating the need to navigate to Data Central Configuration. A new ‘Link to Review Objective’ option (clipboard with link icon) is available in Data Central Listings in the toolbar '+' menu, Visualizations, eIQ Review Models, and Orchestrator Rules in their toolbars, and Workspaces in the more (ellipsis) menu next to the Workspace dropdown, providing a consistent way to associate review materials in context. 

Selecting this option opens a window where users can search, sort, filter, and link one or more Review Objectives. Review Objectives already linked to the selected material appear pre-selected at the top of the list and cannot be unselected without navigating to Data Central Configuration. Additions follow the standard approval workflow, accepting edits for objectives in Configuring status and versioning those already approved. The window also includes a gear icon that navigates directly to the Review Plan in Data Central Configuration. 

This enhancement streamlines workflows, reduces context switching, and ensures Review Objectives are linked accurately at the point of use.

Users can now export and import a single Graphical Patient Profile (GPP) configuration as a JSON file directly from the GPP configuration view. This enables reuse and migration of profiles across studies and URLs without requiring a full Data Central configuration export. 

Each export captures the complete configuration of the active GPP and generates a timestamped file name for traceability. 

The import process validates profile names, required fields, study-specific domains, and chart configurations to ensure compatibility with the target study. Imported profiles populate supported GPP settings through the standard Data Central import workflow. Users are prompted to resolve naming conflicts and validation issues before saving. 

Export and import actions are recorded in the audit trail, providing visibility into when and which GPP configurations were exported.

Query action windows in Data Central have been standardized across supported EDC systems, including Medidata Rave, Veeva CDMS, and Inform, to provide a more consistent user experience. 

Required fields are clearly indicated, character counts display where applicable, and confirmation button labels are aligned across common query actions such as open, answer, close, cancel, requery, and reopen. These updates reduce confusion and provide a more predictable workflow when managing queries across studies.

Review Objective statuses now update in real time to reflect changes in linked review materials, ensuring statuses represent the current configuration and reviewability. Status recalculation is automatically triggered when review settings or linked materials are modified, including changes to domain and data store reviewability; enabling or disabling eIQ Review models, RBQM, and Analytics apps; deletion of Orchestrator rules or updates to action configuration; and deletion, scope, or visibility changes to listings, visualizations, and workspaces. 

This update eliminates stale statuses and provides accurate, up-to-date visibility into review readiness without requiring manual recalculation or waiting for the next scheduled review cycle.

Users can now filter and view icons for all Issue substatuses. 

Open – Reopened, Open – Pending, Closed – Snoozed (for KRI/QTL Issues), and Closed – Irresolvable are now visible and filterable in the Status column of both the Data Central and Global Issues listings, and are also included in exports.

Added the ‘Contingency Actions’ field to the Risk Control section of the Risk Assessment form in RACT to define and track contingency actions when a risk is realized despite mitigation efforts. 

It is also included across Risk Management workflows for consistent visibility and use:

• Included in the Study Risk Management Plan, the export of a finalized Risk Assessment in RACT
• Available in Risk Management Configuration > Assessment Settings, under the Form tab in the Risk Control section
• Available in Risk Management Configuration > Risk Libraries, in the Add / Edit Risk form

When a risk is selected from the Risk Library, any defined Contingency Actions automatically populate in the Risk Assessment form to support consistent risk response planning documentation.

Added an optional review and approval workflow for RACT Assessments to improve collaboration, transparency, and control throughout the assessment lifecycle. Users can be assigned as Participants, Owners, Reviewers, and Approvers, with role-specific permissions. Owners can submit assessments for review, withdraw submissions, and finalize assessments, while Reviewers and Approvers can complete reviews or request revisions at their respective stages. Email notifications and workflow indicators provide visibility as assessments progress through each stage. 

Added the ‘Comments & Activities’ board to support collaboration during review. Users can add and track comments at the risk and assessment level for unfinalized assessments, including @mentions to involve other elluminate users. The board captures comment activity, status updates, and workflow actions, which are retained with finalized assessments to support traceability. 

Added the ‘Documentation’ button to open the Documentation window, providing a structured approach for maintaining version details, protocol changes, and change history. 

These updates improve the ability to configure, review, and finalize assessments while supporting governance, audit readiness, and efficient risk assessment management across studies.

Added the Profiles tab in RBQM with Sites and Countries subtabs to provide a centralized view of site- and country-level performance. The tab content highlights key KRI drivers and related actions, including risk observations and issues, to improve visibility into study operations.

These profiles enable users to identify underperforming sites and countries, supporting targeted monitoring, follow-up actions, and audit planning for proactive risk management.

Added the ability to update the level of a risk signal in RBQM. Users can edit or promote a risk signal record and select the 'Change Level' button to open the Change Level window, where the scope can be adjusted between subject, site, country, and study levels to reflect the impact of the underlying issue.

This enhancement supports dynamic risk management by allowing teams to escalate localized concerns or refine broader signals as patterns evolve, while maintaining traceability and context.

Added Risk Signals actions in RBQM to enable study teams to identify, manage, and escalate potential risks before they become confirmed issues.

Key actions include:

• Create and categorize signals: Capture emerging concerns at the study, country, or site level.
• Answer and comment: Support structured communication and cross-functional collaboration.
• Edit and reassign: Update ownership, priority, and due dates to maintain accountability.
• Close and snooze: Close records that are answered and no longer relevant, or snooze records for later review.
• Reopen signals: Reopen closed records when additional investigation is needed.
• Combine signals: Consolidate related records with the same root cause to reduce duplication.
• Promote to issue: Escalate confirmed problems into formal issue tracking.

Added the new Risk Signal creation feature in RBQM to enable proactive capture and documentation of potential risks. Risk signals can be created at the study, country, or site level, allowing teams to accurately reflect the scope of a concern and address emerging risks early.

This enhancement helps study teams document observations, collaborate on risk evaluation, and manage potential issues before they escalate into confirmed problems.

The new Risk Signals page in RBQM provides a centralized and structured view of risk signal summary data and analytics for alerts, risk signals, and RBQM issues within a study. This enhancement improves visibility, traceability, and collaboration by combining analytics with detailed record management.

Key capabilities include:

• Risk Signals table: Displays alerts, signals, and RBQM issues in a centralized table with sortable and filterable attributes such as status, priority, assignee, and due date, enabling quick identification of items requiring attention.
• Details panel: Provides a contextual side panel with additional record details, including history, linked child records, and status changes.
• Comments section: Captures discussions, responses, and actions for each record, supporting transparency and maintaining an audit-ready history of risk management activities.

Added support for assigning risk signals and enabling collaboration with non-licensed users in RBQM workflows, including CRAs, site monitors, and external partners. These users can be included in alerts, risk signals, and issues, allowing broader participation in risk management activities without requiring a full platform license.

This enhancement strengthens cross-functional communication by ensuring all relevant stakeholders can review, respond to, and address risk-related observations. It also supports alignment with ICH E6(R3) guidance by improving documentation, traceability, and timely risk mitigation across study teams.

Introduced the Risk Signals workflow in RBQM to improve how risks are tracked, communicated, and managed. This enhancement strengthens the end-to-end lifecycle of risk detection, collaboration, and escalation.

Key capabilities include:

• Export functionality: Enabled export of risk signals and alerts to Excel to support offline review, reporting, and stakeholder discussions.
• Email notifications: Added automated and optional email notifications to inform assignees and relevant stakeholders when signals are updated, escalated, or become overdue.
• RBQM engine alignment: Updated RBQM engine-generated issues to be categorized as alerts, ensuring a consistent workflow of Alert (potential risk derived from QTL/KRI threshold breaches) to Signal (managed risk) to Issue (confirmed problem).

Added a Risk Signals card to the Risk Management home page and a dedicated Risk Signals tab in RBQM to provide access to the Risk Signals page and improve visibility of risk signals.

The Risk Signals card displays aggregated counts and statuses of risk signals and RBQM issues, providing a high-level snapshot of risk activity. The Risk Signals tab provides a centralized workspace to access risk signals, alerts, and RBQM issues in one place, supporting consistent risk management workflows.