Life Science Analytics Cloud (LSAC) is the leading AI-powered clinical analytics platform from Saama that seamlessly integrates clinical trial data, delivering more actionable insights for faster decision making. Saama’s proven suite of cloud-based applications in LSAC offer powerful data aggregation, monitoring, analytics, and collaboration capabilities, so sponsors and CROs can optimize study planning, enrollment, compliance, productivity, and oversight.

This document contains important information on new features and updates for LSAC v3.3.

This section gives a list of new features and/or updates for each module worked upon or improvised.

COM-1050: Breadcrumb should be displayed when the user navigates to a dashboard using search and drill down. 

When a user navigates from one report or dashboard to another, using drill-down or search, the appropriate new breadcrumb will be displayed through the Focus and Analytics dropdown values.

COM- 1566: LSAC 3.0 – Custom Configuration List – Product Release Request

Maintain custom configuration lists for smoother release upgrade process. 

COM-2030: Enhancement in ‘Site Activation Dashboard –Study’ 

The ‘Site Enrollment Status’ widget will enable the Study Manager to see the list of Top 5 and Bottom 5 performing sites by status, including zero enrolling sites. It will also give insights for Active sites which are actively enrolling and the list of sites which are active but have zero enrollment. 

COM-2031: Export PDF functionality on Portfolio Summary & Site Summary Dashboard

The export PDF functionality allows the user to export a dashboard in PDF format to the local drive. This facilitates the file to be used for offline review, sharing, presentations and for collaboration. This feature has been implemented for the Portfolio Summary dashboard and Site Summary dashboard for this release. 

COM-2032: Decimal values enabled on Planning Data

Decimal values (up to 2 decimal places) are accepted while entering study planning information such as Study Planned Recruitment Count and so on, for recruiting subjects per site, when these can be average numbers per month. The following variables can take decimal values:

• Study Planned Recruitment  - recruitmentcount
• Site planned enrollment - enrollmentcount
• County planned recruitment - recruitmentcount
• Site planned statistic - statval
• Study planned Statistic - statval

COM-2067: Enhancements in ‘Safety Summary dashboard – Study’

The list of enhancements in the ‘Safety Summary dashboard – Study’ is as follows:

• Cumulative SAE/AE Event Overtime: Renamed the widget to AE/SAE Trend and introduced a View By: Month toggle to see AE/SAE relatedness to the IP (Investigational Product).
• New widget introduced – AE Term by Frequency that gives the count of occurrences of every AE term.
• Segregation of AE terms, in Adverse Events by Body System widget, has been done in the following manner:
  • Non-Serious Related Adverse Events
  • Non-Serious Non-Related Adverse Events
  • Serious Related Adverse Events
  • Serious Non-Related Adverse Events 

• Enhancements in Smart Search Powered by DaLIA*

COM-2109: DaLIA configuration with Master Study filter    

DaLIA configuration and the Master Study filter are in agreement now.

• As a user, you can use the master study filter to limit which study/studies can be viewed throughout the application and the same is carried forward into the DaLIA output.
• The master study filter is also driven by the users of the Data Access Group where users can be given access to all of the studies or to a subset of the studies and DaLIA will be aware of the defined access for each user/user group.
• DaLIA’s current auto completion feature will limit the output data based on user access defined and as per the study selected under the Master Study Filter.

COM-2065: Code Refactoring for DaLIA

The following performance improvements have been done:

• Improved model accuracy for intent identification.
• Improved entity identification and a more robust feature with high accuracy.
• Able to identify entity outliers on the basis of account entities provided.
• Dynamic handling of the data view of query in query formation work.

COM-2116: DaLIA – Grammatical and Formatting Changes

 The grammatical & formatting changes are as follows:

• Study ID, Site ID, Study Name, and Subject ID are in Uppercase in the DaLIA output summary/response action.
• Country Name, Site Name, Region Name and all other entities are in Title case.
• Suggestive questions are in Sentence case.
• Milestone dates in numerals take the format of: DD/MM/YYYY. For instance, 18/05/2016.
• Based on client-specific formatting inputs, study names may appear in Uppercase in the search bar/output summary.

COM-2055: DaLIA – Frequently Asked Questions

Top 5 Frequently Asked Questions will be maintained and displayed in the DaLIA search bar for every client account. A user can use these FAQs directly to view the output or modify these questions as per the query requirements.

Also as and when the user is typing any question in the DaLIA search bar, only those FAQs will be displayed in the search bar that match the keywords entered by the user in the query.  

COM-2063: Auto Completion of Questions

The user can now use the up and down arrow keys from the keyboard to shift through the suggestive questions in the DaLIA dropdown. The highlighted/selected question will then appear in the DaLIA search bar. Users can view the response to that question by pressing Enter or choose to modify the query that appears in the DaLIA search bar.

COM-2115: DaLIA output change – TOP N/BOTTOM N Questions

The Note section, which appears just below the output response title, is modified for specific              queries, namely, Top N/Bottom N studies/sites/countries to indicate which column has been used for grouping results. This would reduce any ambiguity for the user. 

COM-1837: DaLIA output/response maintains context for suggestive questions, namely, (Would you also like to see?) for Top N/Bottom N intents.

“Would you also like to see?” questions are modified for Top N/Bottom N intents and categories, i.e. queries and dispositions. These modified suggested questions give deeper insights to the user and increase engagement for DaLIA.

COM-980, COM-2049, COM-2059, COM-2335: Introduction of new intents and entities enabling additional insights

*Note: DaLIA’s responses or answers-to-queries are determined by the data present in the USDM (Unified   Standard Data Model) and by the underlying data that is processed to draw out the various OOB KPI analytics. DaLIA is not trained to respond to any query based on custom configurations or to any query based on the OOB KPI Studio reports; response to such a query will be inaccurate or null.

• RACT (Risk Assessment and Categorization Tool)

COM-1842: Duplicating and saving existing Custom RACT (Risk Assessment and Categorization Tool)

• Users are able to save a RACT template at any point of time (without submitting it) and are able to re-purpose an existing custom template by tweaking it to meet requirements and then by saving it as a new RACT template. 
• Users can also view or duplicate any existing RACT template, within the account, and the user with Super Admin access will be able to delete any existing templates. 

COM- 2050: RACT: KPI for each risk category

Related KPIs defined for each enabled risk category, within the risk scorecard, enables users to assess the performance of each of the identified risk categories through related dashboards, reports and KPIs specified in the related KPIs section within the RACT console.

COM- 1099: Link Monitor to Risk Subcategory

• Users are able to link one or more OOB Monitors to a risk subcategory through drop-down selection initiated in the risk subcategory console.
• The selected monitors will be linked to the enabled risk category and the users can navigate to these monitors by hovering over the risk category, on the Risk Card, and then selecting the monitor. 

COM- 2122: RACT Console Formatting Updates

RACT console and its components have been formatted to fix visual and grammatical issues. 

The following bugs have been fixed for LSAC release 3.3:

There are no new open issues.

Customers can submit issues via our support portal (Support.saama.com) or calling the support line (866) 619-9995 during normal business hours. For any other query customers can contact us on the email address: support@saama.com