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 v3.5.

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

COM-2593: Enhancement in ‘Safety Summary Dashboard – Study’ – Enable Study Site View option to the AE/SAE Trend widget. 

Examine the count of adverse events/serious adverse events in every active site in all participating countries of a selected study. Sites are listed in ascending order of performance relevant to the KPI, so that the user can get a quick reference of every site’s performance with respect to frequency and occurrence of adverse events. 

COM- 3167: Enhancement in ‘Site Activation Dashboard – Study’ – Enable ‘Milestone Cycle Time’ for all startup/conduct milestones across all participating countries.

Assess the milestone cycle time for all participating countries of a selected study, thus enabling better monitoring and measurement of various milestones across countries. The legends of milestones are configurable as to what the user finds applicable.

COM-2182: Enhancement in ‘Enrollment Dashboard - Study’: New category - Subject Disposition added to the Enrollment Funnel. 

Addition of a new Subject Disposition i.e. In Screening, Ongoing, Follow up, Lost to follow up in the Enrollment Funnel enables the user to track trial progression.

COM-3168: Enhancement in the ‘Site Activation – Listing’ 

Addition of two new columns, namely, Planned Site Activation Date and Site Status enable users to see the current status of the site.

COM-3390: New Report: Data Refresh

The Data Refresh – Listing analytics report allows the users to know the most recent data refresh time.

COM-3358: Revamped ‘Portfolio Summary Dashboard ’ 

The new ‘Portfolio Summary Dashboard’ provides the ability to drilldown to the Treatment Arm/Cohort for all applicable KPI. Additional flexibility is offered to group data by Study/Therapeutic Area/Sponsor/Phase/CRO/Status and functionality to show/hide metrics, freeze column and reorder KPI for improved user experience.

COM-3359: Revamped ‘Site Summary Dashboard ’

A comprehensive view of individual study site performance along with comparability against study and country mean is presented for every active and enrolling site. Additionally, the functionality to show/hide metrics, freeze column and reorder KPI for improved user experience. 

COM-2525: Export-to-PDF feature enabled for below key dashboards to provide portability and collaboration.

The Export to PDF feature has been implemented on the following dashboards. Queried/Resultant data can be exported in a PDF format for better accessibility.

• Portfolio Summary Dashboard - Study
• Study Summary Dashboard - Study
• Site Activation Dashboard - Study
• Enrollment Dashboard - Study
• Safety Summary Dashboard - Study
• Quality Measures Dashboard - Study
• Data Metrics Dashboard - Study
• Site Summary Dashboard - Site

COM-3618: Harmonizing KPI logics/derivation across all dashboards and on all result-oriented widgets.

KPI derivations for some of the key metrics have been standardized to make them consistent across all dashboards and result-oriented widgets. 

The Subject Progression dashboard charts the sequence of events for every subject as part of the clinical trial - like, Disposition changes, dosing information, any AE/CM events, and so on.

COM-3103: New monitoring dashboard ‘AE Reporting Delay dashboard – Patient Profile’ 

The AE Reporting Delay dashboard captures the time delay between the occurrence and reportage of adverse events, for multiple subjects of a specific active site. Discrepancies like a missing start date are highlighted to improve overall data compliance and quality.

COM-3106: Enhancements in ‘Graphical Patient Profile dashboard – Patient Profile’

The GPP dashboard has been enhanced to give details on the four components that give a comprehensive view of a subject’s health, subject details and a subject’s exposure to dosing, AEs and CMs. The user can also drill down for more insights like CM listing, AE listing for a subject. These four components seen for every subject are listed below:

• Demographic Summary
• Subject's exposure to dosing
• Lab results
• Sequence of AEs and CMs over a period of time

Each widget within the GPP is now enabled with asynchronous + partial load techniques for improved performance.

COM-3158: New monitoring dashboard ‘Lab Spaghetti Plot – Absolute Value – Patient Profile’ 

The Lab Spaghetti Plot – Absolute Value dashboard charts lab observations/values for a specific lab test/category for multiple subjects across multiple sites, and visits. The changes in lab test values are recorded and its trajectory is unique for every subject allowing medical and safety monitors to identify outliers/noise as well as safety risk.

Lab analytics table lets you drill down deeper into the lab results for the specific subject.

COM-3163: Addition of ‘Lab Spaghetti Plot – Baseline Deviation dashboard – Patient Profile’ examines the deviation of the lab test results from the baseline.

The Lab Spaghetti Plot – Baseline Deviation dashboard records lab test values of multiple subjects from multiple sites, across several visits. Examine the percentile deviation of the lab test and observe the inliers and outliers. The study average for a specific lab test can also be seen in the graph.

COM-2606: New monitoring dashboard ‘Adverse Events – Toxicity Profile - Study’

The ‘Adverse Events – Toxicity Profile’ dashboard provides patient-level counts of every unique adverse event that is categorized by SOC and AE TERM across treatment arms. The user can drill down to fetch more AE details on each of the subjects associated with every adverse event.

COM-3215: The list of Analytics has been updated under the Clinical Insights section to reflect all the dashboards and reports that fall under their respective Focus.

COM-2915: Server response time has been considerably reduced when querying on the Graphical Patient Profile dashboard thus enhancing performance.

GPP is able to handle large amounts of data within EX or other tables for which it queries.

• Enhancements in Smart Search Powered by DaLIA*

COM-2781: Enhancement on DaLIA output: When the resultant (output data), of a DaLIA query, exceeds 25000 records, the user can download the result for better viewing and accessibility.

Instead of viewing the output data, where records exceed 25000 in number, the user will be able to download the result as a CSV file for better viewing, accessibility and portability. 

COM-2481, COM-3096, COM-3097, COM-2060, COM-3151, COM-3143: 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.

• Enhancements in the USDM Data Model

COM-3698: The USDM Data Model has been expanded with the addition of 4 new data tables to support AE, Oncology, and Tumor assessments and for Data Refresh report. Column updates have been made to existing tables to support site-level and country-level results. 

The USDM Data Model has been expanded to include the following new tables to support AE, Oncology, and Tumor assessments and for Data Refresh report. These tables are as follows:

• tr - Tumor/Lesion Results
• tu - Tumor/Lesion Identification
• rs - Disease Response and Clin Classification
• countrymilestone - Country Milestones
• source_system_refresh_time - Source System Refresh Time

New columns have been added to the following existing tables to support site-level and country-level queries. These tables with their respective column additions are as follows:

• site - Sites: One ew Column - siteplannedactivationdate
• ae - Adverse Events: Three new columns - aerptdt, preferredterm, aesi
• dm - Demographics: Three new columns - studyname, sitename, sitecountry
• sv - Subject Visits: Five new columns - studyname, sitename, siteregion, sitecountry, sitecountrycode
• ex- Exposure: Five new columns - studyname, sitename, sitecountry, drugrsp, drugrspcd, 
• lb- Lab Data: Five new columns - studyname, sitename, siteregion, sitecountry, sitecountrycode
• sitemilestone - Site Milestones: Four new columns - milestoneid, milestonelabel_src, milestonelabel_long, milestonecat
• siteissue - Site Issues: One new column - maskingtype

The following bugs have been fixed for LSAC release 3.5:

The Open (Known) issues are listed below:

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