Release Notes

December 2025

New Features & Enhancements

Read-only Mode: When multiple users access a shared KerusCloud® project, the first user receives full access based on ownership or their Sharee Access Role. All subsequent users, including the project owner, will view a read-only version of the project. In Read-only Mode, users cannot make changes, and will only see saved updates made to the project upon navigating through the project wizard.

Restrict Analysis Defined By: Variables with only 1 level will not appear in the Defined By list of an analysis.

Restrict Analysis Covariate List: Variables with only 1 level will not appear in the list of Covariates.

Cascading deletion of Time-to-Event variables is prevented: Updates to constituent variables will no longer trigger deletion of the associated Time-to-Event variable.

Continuous RM variable type selection may be disabled: When potential applicable constituent variables do not exist, selection of Continuous RM variable type is not possible.

Miscellaneous:

Decision Criteria: UI update applied so that the Sided argument is no longer displayed for a selection of Confidence Interval output metrics (for Chi-Squared Test, Two Sample T-Test, One Sample Proportion Test, One Sample T-Test and Binomial Summary analyses), the Sided argument is assumed to be two-sided.
Decision Criteria: Confidence Interval Output metrics now assume two sided for Cochran-Mantel-Haenszel Test, Fishers Exact Test, Two Sample Proportions Test, and Summary on Continuous distributions.

Bug Fixes

NA time values are now ignored when adjusting the Time-to-Event times for an interim analysis dataset.

November 2025

Patch

Correlations: A fix has been deployed addressing an edge case detected in the KerusCloud® Correlations module. The edge case identified is restricted to projects making use of scenario-based Correlation values correlating scenario-based variables.

November 2025

Enhancements

Enhanced Combined Decision Criteria: Combined Decision Criteria has been enhanced to allow users to combine up to eight individual Decision Criteria. A new plot visualisation has also been introduced to help users explore and interpret the results of different Decision Criteria combinations more effectively. This enhanced version of Combined Decision Criteria now also supports the implementation of a fixed sequence testing method.

Miscellaneous:

Decision Criteria: For a selection of Confidence Interval output metrics, the Sided argument is now assumed to be two-sided, the affected analyses are Chi-Squared Test, Two Sample T-Test, One Sample Proportion Test, One Sample T-Test and Binomial Summary. The corresponding UI update for this change will be delivered in December 2025.

October 2025

Enhancements

Virtual Population QC Visualisations: Added the ability to download Virtual Population QC data, including table data and simulation-level data, making it easier to analyse and share results.

Miscellaneous:

Strengthened Content Security Policy to further limit external connections, enhancing protection against potential data leaks and unauthorised access.

September 2025

New Features & Enhancements

Revamped Virtual Population QC Visualisations: A new, user-friendly and scalable implementation of Virtual Population Quality Control (QC) visualisations has been introduced, offering improved usability and clarity for users.

Miscellaneous:

Improved Scenarios Navigation: When adding new scenarios, the KerusCloud® UI now automatically scrolls to and focuses on the newly created scenario.
Performance Improvements: Optimization of internal data handling within the KerusCloud® UI.

Bug Fixes

Resolved an issue where the list of scenarios was incorrectly displayed after navigating away from unsaved new scenarios in the KerusCloud® UI.
Fixed a bug where the project lock was not correctly released when leaving the Decision Criteria (DC) Simulation Level page, within the KerusCloud® UI.
Addressed an edge case affecting DC Visualisation plots related to Sample Size Re-estimation Design.

August 2025

New Features & Enhancements

Two Sample Restricted Mean Survival Time (RMST) Analysis: An extension to the recently released analysis for Time-to-Event variables, focusing on a specified subpopulation and enabling comparison of RMST between two groups. This feature is currently behind an experimental flag.

Miscellaneous:

Update to latest version of Angular framework: To maintain the robustness of KerusCloud®, taking advantage of the latest Angular optimizations, bug fixes, and security improvements.
Performance Improvements: Optimization of database, API and internal data handling within the KerusCloud® UI.

Bug Fixes

Auto-sizing metric dropdown selections for Decision Criteria Definition.
Hwang-Shih-DeCani Algorithm report generation failure.

July 2025

New Features & Enhancements

One Sample Restricted Mean Survival Time Analysis: Addition of a new analysis for Time-to-Event variables, for either the population or a specified subpopulation of interest. This feature is currently behind an experimental flag.

Miscellaneous:

Replace PrimeNG with Angular Material: PrimeNG components are being replaced with Angular Material for better long-term compatibility and support with Angular core updates.
Performance Improvements: Optimization of database, API and internal data handling within the KerusCloud® UI.
Specific Logic for Multiplicity DCs has been statistically validated and is now considered stable.

Bug Fixes

Lower Limit for Significant Digits has been corrected to 1. Previously, users could enter a value of 0.

June 2025

New Features & Enhancements

Specific Logic for Multiplicity Decision Criteria: A new logic type has been added for Multiplicity Decision Criteria allowing users to query the result of a specific p-value based single Decision Criteria. This is with an experimental flag, see below.

Experimental Flag: Demarking internally validated features, awaiting final statistical validation.

Miscellaneous:

Project data retrieval performance improvements. The latest security patches have been applied.

Bug Fixes

Miscellaneous fixes handling edge-cases resulting from extreme project configurations:

Fisher Exact Test successfully returns Upper and Lower Confidence Interval metrics.
Advanced Options are successfully applied to all layer based variables.

April 2025

New Features & Enhancements

Instance Size Choice: Three speed options are available to run each task based on the instance size used: “Eco”, “Normal” and “Fast”. Allowing the user flexibility when running tasks versus using credits based on need.

March 2025

New Features & Enhancements

Refreshed Decision Criteria Visualisations: The Decision Criteria Visualisations section of the application has undergone a significant refresh. Users can now create, filter, save, view and download multiple heatmaps and set project-level heatmap settings for optimised customisation and flexibility.

Event-driven Interim Analyses: Addition of new Interim Time Type, “Number of Events”, to facilitate Event-driven Interim Analyses.

Summary Analysis: The “Summary” analysis type is now available for Time-to-Event variables, replacing the “Summary (Kaplan-Meier)” analysis type. The following metrics have been added for this analysis type: “Number of Events at Given Study Time”, “Study Time to Given Number of Events”, “Number Censored at Given Study Time” and “Study Time to Given Number Censored”.

Miscellaneous:

The latest security patches have been applied.

Bug Fixes

Distribution-based variable parameter names are consistently displayed, and the choice of distribution type will be distinct for each variable parameter.
Variable parameters now reset when the variable type is changed.
Miscellaneous fixes handling edge-cases resulting from extreme project configurations.

February 2025

New Features & Enhancements

Sample Size Reestimations: Added a new type of maximum limit for Sample Size Reestimation Adaptive Designs: Absolute Value.

Summary Analysis: Two new “Summary” analysis output metrics for Recruitment variables: “Number Recruited at Given Study Time” and “Study Time to Given Number Recruited”.

Help Button: Improved granularity when using the help button to navigate the user guide.

Bug Fixes

Prevent the user from being able to save a single Decision Criteria with no left hand side component.
Recruitment Period ranges are now displayed when inputting the Recruitment Rate variable parameters.

January 2025

New Features

Added Estimands on Time-to-Event variables with the following strategies: No Change, Variable Treated as Event, Variable Treated as Censor
Added comparison of two variables in an Estimand condition
Added option to change application theme, choosing between default, dark, dark blue, tritanopia, protanopia, deuteranopia
Added number of applied advanced options to review wizard page
Added Estimand indicator to variable wizard review page
Added settings page to allow user to change the application theme
Added breadcrumb navigation to top-bar
Added tooltip to display a project description whenever the text is truncated on either the dashboard or project list
Updated contact support link
Improve Subgroup Semantics to distinguish between target and reference subgroup when creating a DC and generating a report

Enhancements

Updated iconography throughout application
Updated font style throughout application
Updated display of inputs throughout application
Updated display of date selector throughout application
Updated display of buttons throughout application
Updated display of wizard pages throughout application
Updated display of tables throughout application
Updated display of recent activities on dashboard
Updated scaling of interface on smaller screens
Updated display of sidebar
Updated display of dashboard notification and recent activity scrollbars
Updated summary value display on dashboard when no data is present
Updated display of empty tables and images
Updated project detail summary display on project board
Updated display of project output section on project board
Updated display of project shares on project board
Updated edit project button on project board
Updated credit ledger button on project board
Updated login page background and structure
Updated background overlay when dialogs are open
Added border to dropdown items
Added hover effect on project board stages
Updated font size throughout application
Updated keyboard only usability throughout application
Updated clickable area on sidebar links
Updated default application colours to provide a higher contrast
Updated mouse display on disabled elements such as buttons or inputs
Added application themes to support users with colour blindness
Added focus outline to inputs
Added screen reader improvements to inputs and images

Bug Fixes

Fixed issue between password change and MFA process
Fixed MFA status being incorrectly reflected on profile
Fixed issue with search bar returning incorrect results on analysis wizard
Fixed table content wrapping
Fixed QC rendering
Fixed Estimand replacement strategies input validation
Fixed display issue with MFA button on profile page
Fixed issue where password reset error message would not display
Fixed issue where last modified date would not display correctly
Fixed issue where self-dependent correlation could be created

2024

December 2024

New Features

Recruitment: Patient Recruitment has been holistically implemented within KerusCloud® allowing user to:

Add/Edit/Delete a Recruitment Variable.
Add/Edit/Delete up to 10 Recruitment Sites.
Add/Edit/Delete up to 10 Recruitment Periods within a Site.
Add/Edit/Delete Recruitment Scenarios.
Add/Edit/Delete Site Caps.
Ability to use a Recruitment Variable in an Analysis.
Addition of Recruitment in Project Report.
Bespoke Recruitment quality control metrics on Virtual Population QC.
Percent Recruited and Number Recruited now available as options in Adaptive Designs.

Metadata in Virtual Population Download:

Metadata file included in the Virtual Population data Download.
Project Details included in metadata
Variable information included in metadata
Recruitment information included in metadata

Enhancements

Estimands

Estimand Conditions evaluated and applied taking variable timepoints into consideration.
Estimand Replacement strategies evaluated and applied taking variable timepoints into consideration.

Documentation: Access to the documentation within KerusCloud® has been improved allowing a user to resize the sidebar to improve accessibility. Improved structure of documentation website for use in accessibility tools.

Miscellaneous

Increasing upper limit of sample size to 20000
Enabling interim time type selection on Adaptive Designs
Enabling covariate term values when creating a DC or adaptive design
Enabling MMRM Time as Numeric

January 2024

New Features & Enhancements

Single Sign-On: Access to KerusCloud® will now be using your Windows Logon credentials. This reduces the number of passwords a user must manage and ensures user organisations can manage the application using their own security policies.

User-interface Updates: The user interface has been updated to the latest version which improves the functionality for accessibility tools, such as screen readers. This update also improves the performance of the application reducing loading times. In addition, this ensures the latest security measures have been adopted.

2023

October 2023

New Features & Enhancements

Layer Based Irreversible Events: Irreversible events can now be defined by up to 3 other variables, enhancing the flexibility and utility of the irreversible events.

Embedded Help and Documentation: To provide a more seamless and user-friendly experience, we are introducing embedded help and documentation links, making it easier for you to access essential information and guidance directly within the application.

Introduction of Spinner on Save: We have added a spinner to the save process, providing visual feedback to ensure you are aware of the status of your actions.

Snack-bar Message Updates: Snack-bar messages have been updated to be more informative and user-friendly, helping you stay informed about important events and changes within the software.

Improved Validation: Validation on data entry has been enhanced to maintain the flexibility of potential data whilst ensuring the robustness and accuracy of simulated data.