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 v3.4.

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

COM-2029: Enhanced Enrollment Dashboard – Examine the count of Screen Failure due to Reason segregated on I/E Criteria. 

Assess the count of subjects that failed Screen Failure due to I/E criteria to drive a correlation between I/E criteria and Screen Failure.

COM- 2091: Ability to freeze columns and rows in Listings

Freeze Column and Header Row in Listing reports for improved user experience when scrolling down and to the right. For any Listing in Clinical Insights, ‘freeze’ the top row (header) and first few relevant columns, i.e. Study Name, Study ID, for a better viewing experience.

COM-2454: Addition of ‘View By: Site’ to all the four widgets in ‘Data Metrics dashboard – Study’ brings focus to assessing site performance for a specific visit.

Users will be able to track site-wise data metrics for the following widgets: 

• Data Points Completion
• Avg Time b/w Data Collection and Entry in Days
• %SDV Completion
• %Primary Endpoint Completion

COM-2455: Addition of ‘View By: Site’ to the Total Enrollment widget in Enrollment dashboard – Study brings focus to site performance with respect to Enrollment.

Users will be able to assess enrollment behavior on every participating site in Total Enrollment widget. The participating sites for a specific study are sorted in ascending order of performance, relevant to the KPI, so that users can get a quick reference of every site’s performance with respect to enrollment.  

COM-2536: The widgets, namely, a) Protocol Deviations Over Time, and b) Count of Protocol Deviations have been replaced by a new widget Protocol Deviation. 

Addition of ‘View By: Site’ to the Protocol Deviation widget in Quality Dashboard – Study brings focus to site performance with respect to Protocol Deviation. 

Furthermore, ‘Site Count’ tooltip has been added for every country and can be seen on hover under ‘View By: Status’ 

The widgets, namely, a) Protocol Deviations Over Time, and b) Count of Protocol Deviations have been replaced by a new widget, namely, Protocol Deviation that contains the analytics from the previous two widgets.

Users will be able to view the count of protocol deviations for every participating site and will thus be able to assess site performance with respect to Protocol Deviations. The participating sites for a specific study are sorted in ascending order of performance, relevant to the KPI. 

Introduction of Site Count on hover under View By: Status in the Reported Site Issues widget.

COM-2548: Subject Completion by Visit widget has been removed from the ‘Enrollment dashboard – Study’ 

Subject Completion by Visit widget has been removed from the ‘Enrollment dashboard – Study’. 

COM-2605: Introduction of a new widget, namely, Study Site Progress Status in Site Activation dashboard – Study. 

A new widget, namely, Study Site Progress Status has been introduced in ‘Site Activation dashboard – Study’ that gives a monthly as well as the cumulative assessment of site behavior. The View By: Month gives a count of all sites categorized into status, for a specific month. The View By: Cumulative gives a cumulative count at any point in time, that is, a sum total of sites in different statuses up till the marked point in time. The Count of sites will be sorted into categories, based on the backend data. As an instance, count of sites can be placed into the following categories, as i) Active ii) Archived iii) Cancelled iv) Candidate v) Closed vi) Initiating vii) Not Available viii) On Hold ix) Proposed x) Terminated

COM-2604: Introduction of a new widget, namely, Milestone Cycle Time in Site Activation dashboard – Study.

A new widget, namely, Milestone Cycle Time has been introduced in ‘Site Activation dashboard – Study’ that enables the user to see the mean cycle time taken for the various milestones in different   phases, in terms of study days, across sites in the Study Start Up phase. This allows the user to better track the overall study activation performance on a country-level for all participating sites. 

The widget displays the average cycle time in Study days for the milestones that have been taken into account in the Start Up phase. Some baseline milestones are as such:

• Submission to Approval
• Approval to Activation
• Activation to FPFV
• FPFV to FP Enrolle

• Enhancements in Smart Search Powered by DaLIA*

COM-2583: Sequence of Auto-Fill suggestions provided by DaLIA   

The auto-fill suggestion and sequencing are proposed in the DaLIA search bar when the user enters the entity in the DaLIA search bar.

COM-2584: Study Name and Study ID appear in the auto suggestion provided in the DaLIA search bar

Users will be able to see both the study ID and the study name in the auto suggestion box when a study entity is entered into the DaLIA search bar.

COM-2611: Auto-fill suggestion is governed by the MSF (Master Study Filter)

The auto-fill suggestions provided in the DaLIA search box, when a user enters an entity, are restricted or governed by entity values already present in the MSF (Master Study Filter) that appears in the left search panel of the screen. 

COM-2175, COM-2066, COM-2114, COM-2506: 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-2484: Enhancement of Audit Trail        

The audit trail functionality has been revised to include the following data:

COM-2485: Ability to save an unfinished RACT template and RACT Assessment console

Users will have the ability to save the RACT template or the progress on RACT assessment at any point in time by closing the RACT console by clicking on the ‘X’ mark. All progress is saved and the console can be revisited to work on the assessment.

COM-2486: Access to multiple Risk Assessment versions

Users can have access to previously published versions of RACT template for a study. This facilitates comparison between multiple RACT templates and enables the user to see RACT behavior over time.

COM-2542: RACT Signoff functionality enhancements

RACT Signoff has been enhanced to include the following scenarios:

• Action on RACT approval can be performed only once by each user.
• Only the RACT Author will be able to assign RACT to users to seek their approval.

The following bugs have been fixed for LSAC release 3.4:

Known issue noted as part of the LSAC 3.4 release is as follows:

• The Export-to-PDF functionality fails if the dashboard is set as a Home Page. The Export-to-PDF functionality works as expected if the specific dashboard is navigated to, from the Operation Insights tab. 

• Please note that we are currently working on this known issue and you will be notified once it is working as expected.

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