Release Notes

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”.

Misc: 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

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.

Misc

• 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.

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.