Overview

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 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 v4.1.

New Features/Enhancements

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

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• Enhancements in Clinical Insights

    COM-4802: New X-axis parameter – Study Days for widgets

The addition of the X-axis parameter, namely, Study Days, to widgets represents subject data in correlation to relative study days. The chart starts from the first dosing date of the subjects selected. The Study Days parameter has been implemented in the following dashboards: 

• For Lab Spaghetti Plot – Baseline Deviation - Study Days are plotted according to Lab Days.
• For Safety Summary – Study Days are plotted as 0, 30, 60, 90 and so on, in the interval of 30 study days. 
• For Subject Progression and Subject Event Log, the relative study days calculation is as follows:

• Relative Study Days for AE = AE Date – Subject Start Date
• Relative Study Days for CM = CM Date – Subject Start Date
• Relative Study Days for Dosing = Dosing Date – Subject Start Date
• Relative Study Days for Disposition = Disposition Date – Subject Start Date

COM-4136: GPP Enhancements 2.0

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The Graphical Patient Profile dashboard has been enhanced to include the following:

• AE Severity Grading Over Time

The horizontal bar will depict AE severity over time through color-coded labels and indicators that have been specified in the configurable GPP template.

• Configurable Subject Metadata

Metadata visibility in GPP can be customized from the Data tab in the GPP template, except for the following infographics that would always be present whenever the dashboard is rendered. These are, i) Study Name, ii) Study ID, iii) Site Name, iv) Site ID, and v) Subject ID

By default, GPP metadata comprising of all the infographics will be visible when subject data is rendered. These are, i) Study Name, ii) Study ID, iii) Site Name, iv) Site ID, v) Subject ID, vi) Therapeutic Area, vii) Medical Indication, viii) Phase, ix) Gender, x) Age, xi) Date of First Dose, xii) Date of Last Dose, xiii) Discontinuation Date, xiv) Discontinuation Reason, xv) Cause of Death, xvi) Date of Death

Additionally, as an admin user, you can also select the following infographics to be made visible, if required. These are i) Subject Info Query, and ii) Subject Info Query Labels

If data is not available for any infographic, then ‘’–--‘’ will be displayed.

• Addition of ‘Discontinuation Details’ in GPP Metadata

Two new withdrawn details, namely, Cause of Death and Date of Death, will be visible in the metadata/summary card section of GPP. These two metadata elements will only be seen if the discontinuation cause is Death.

• 5-point interval for Y-axis

Subject Exposure data can be distributed into intervals of 5, for better data consumption. The admin user can enable this setting in the Options tab of the GPP template.

• Addition of the Date Range filter

The addition of the dashboard-level date range filter allows the user to view widget data, based on the time period specified in the date range filter. By default, the time period selection rendered on the date range filter is from the start date of the subject’s lab result to the end date of the subject’s lab result or the current date (whichever is earlier).

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COM-4840: Change of source table to capture Drug Response

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Drug Response data as seen on the Subject Progression dashboard will be captured from the source table, namely, RS table – Disease Response and Clin Classification table and not from the EX table as was done earlier.

COM-5098: Subject Data plotted against Lab Assessment Date

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Subject data markers will be plotted at actual lab assessment dates, irrespective of visit date, in the dashboards Lab Spaghetti Plot – Baseline Deviation and Lab Spaghetti Plot – Absolute Value. A lab assessment date can fall between 2 consecutive subject visits and the corresponding logic for the calculation is as follows:

Lab Assessment Date = Visit Number for Visit 1 + [(Lab assessment date – previous visit date)/total number of days between previous and next visit]

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• Enhancements in Operations Insights

COM-4803:  Redesigned – Site Performance dashboard

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The Site Performance dashboard – Study has been redesigned with additional filters and a more effective and user-friendly UI that aids in better data consumption. KPI performance is gauged through the charts, with one chart for one KPI. The 10 most highest/lowest performing sites, based on the KPI selected can be viewed in tabular form. These enhancements are listed below:

• Global filter selection can most easily render data on this dashboard without the need to select dashboard-level filters. 
• Newly added dashboard level filters, namely, Country, and Study Name enable the user to see a more focused analysis.  
• Additional site performance parameter, namely, %SDV Completion has been added to draw out analysis on the same.

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COM-4801: Enrollment Rate calculation stops when LPLD is achieved 

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The enrollment rate measured over a period of time, will stop being calculated, when the milestone LPLD (Last Patient Last Dose) is achieved. If the LPLD is not available, then the LPLV milestone will be considered at the site and study level. The details of the milestones, LPLD or LPLV, in the tooltip of the following widgets will be a good indication to know when the enrollment rate calculation has stopped. These are:

• Enrollment Rate KPI – Portfolio Summary dashboard - Portfolio
• Site Activation and Enrollment Over Time – Study Summary Dashboard – Study
• Site Activation and Enrollment Over Time – Site Activation dashboard – Study
• Protocol Deviations, View By: Month & Year – Quality Measures dashboard – Study
• Enrollment Rate KPI – Site Summary dashboard – Site
• Enrollment Rate KPI – Cross Study Performance dashboard – Site
• Enrollment Rate – Site Performance dashboard – Study
• Subject Enrollment Rate – Study/Country/Site

COM-4781, COM-4738: Newly added attributes – Site Status, Site FPFV, and PI Email

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The attributes, namely, Site Status, FPFV (First Patient First Visit), and PI Email have been added to the following dashboards and listing:

• Oversight Scorecard – Site Status, Site FPFV, and PI Email details can be seen in tooltips on hovering over the Site ID/Name and over the oversight scorecard. New added columns, namely, Site Status, Site FPFV, and PI Email are visible in the tabular view of the oversight scorecard.
• Cross Study Performance – Site Status, Site FPFV, and PI Email are visible when the user clicks Site Details to flip the tile. 
• Site Summary – Site Status, Site FPFV, and PI Email are visible when the Site ID is expanded.
• Listing – Site – Newly added column, namely, PI Email has been added.

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COM-4820: Active Global filter in Site Summary dashboard

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Data can be rendered on the Site Summary dashboard – Study, through study selection made in the Global filter that appears in the Top Navigation Bar without selecting any parameter values in the dashboard-level filters.

COM-4792: Enhanced UX with respect to Data Unavailability

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Based on data availability, site names/ID and KPI name will be greyed to indicate that no data is present, on these specific sites or for these specific KPIs, for analysis. The dashboard, Cross Study Performance, displays the message below the filters as follows:

For grayed out KPI, no data available to display in dashboard

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COM-4814: Widget – ‘Study Site Progress Status’ is now configurable 

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The funnel widget, namely, Study Site Progress Status in Site Activation dashboard – Study, is configurable from source so as to show only those milestones that are applicable. The applied milestones are arranged in the sequence in which they would occur on an active site.

Additionally, three new site statuses have been added and these would be visible in alphabetical order in the funnel widget. These are:

• Active
• Enrollment Open
• Active – No Longer Recruiting

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COM-4982: Lazy Data Loading in Portfolio Summary dashboard

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Lazy loading of data has been implemented on the Portfolio Summary dashboard – Study that allows data to be rendered in smaller chunks to enable a quick data response.

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COM-4993: Correction on AE Category labels

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AE Category labels that are perceived as a combination have been corrected to be read as follows:

• Serious & Related
• Serious & Not Related
• Not Serious & Related
• Not Serious & Not Related

The dashboards & KPIs that reflect the new AE Category labels are, i) Safety Summary dashboard – Study, ii) AE Rate per Subject Days KPI at study, country, and site level.

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COM-4914: Newly added filters in Site Summary dashboard

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New dashboard level filters, namely Country and Site, have been added to the Site Summary dashboard – Study to enable a more focused rendering of data for better analysis. The filters appear in hierarchy order where the prior filter selection dictates the values seen in the filter that appears next. These filters are:

• Country – Multi-select, non-mandatory filter
•  Site – Multi-select, non-mandatory filter