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Product Update

Product Update - LSAC 4.4

LSAC 4.4 Expands Exploratory Clinical Capabilities, Improves Safety Reporting, and Adds New Data Source Adapters

New features to LSAC applications are available in the latest 4 series release. Highlights include an expansion to Smart Clinical Explorer (SCE), support for handling trials with multiple visit schedules and adapters for Veeva and Oracle systems to speed data onboarding. Prefer a video? Watch the LSAC 4.4 updates here.

Clinical Insights

Medical, Safety, and Compliance personnel can quickly review patient demographic information, lab data, adverse events, and concomitant medications to discover trends and patterns with Clinical Insights.

What’s New for Clinical Insights in LSAC 4.4: 

Expansion to Smart Clinical Explorer

Customizable Tooltip in Graphical Patient Profiles (GPP)

Introducing new listings of Vital Signs, Medical History, Electrocardiogram and Exposure

Dashboards Automatically Load with Study Data

  • Subject Progression
  • Graphical Patient Profile
  • Lab Spaghetti Plot – Absolute Value
  • Lab Spaghetti Plot – Baseline Deviation
  • Adverse Event – Toxicity Profile
  • Adverse Event – Reporting Delay

Saving Prime Table Configurations:

Users with Admin access can save/reset the configuration changes regarding column freeze/unfreeze/hide/view/sort and row collapsed/expanded mode functionality.

Functionality is applicable to listings in Smart Clinical Explorer dashboard.

Introducing new listings of Vital Signs, Medical History, Electrocardiogram and Exposure 

Operations Insights

Timely, targeted analytics in Operations Insights enable executives, study managers, and CRAs to monitor and optimize key operational metrics across a portfolio of clinical studies.

What’s New for Operations Insights in LSAC 4.4: 

Loading Dashboards by default:

  • Following dashboards will now load by default. The mandatory filters are marked with a red asterisk mark and take up the alphanumerically 1st active Study value for rendering dashboard.
    • Site Activation Dashboard- Study
    • Enrollment Dashboard- Study
    • Quality Measures Dashboard- Study
    • Safety Summary Dashboard – Study
    • Data Metrics dashboard – Study
    • Study Summary Dashboard

Saving Prime Table Configurations:

  • Users with Admin access can save/reset the configuration changes regarding column freeze/unfreeze/hide/view/sort and row collapsed/expanded mode functionality.
  • The functionality is applicable to following dashboards:
    • Portfolio Summary Dashboard
    • Site Summary Dashboard
    • Site Performance – Study Dashboard
    • Site Activation Dashboard
    • Enrollment Dashboard

Enhancement to Safety Summary Dashboard – Study

  • Cumulative Enrollment line chart is added to Month & Time tabs of AE/SAE trends widget.
  • The tabs of AE/SAE Trends widget are now enhanced with lazy loading functionality.

Enhancement to multiple OOTB & KPI Subject Visit Compliance Dashboard & Listings

  • New columns are added to Subject Visit – Listing & Latest – Subject Visit Listings to display details about baselines, protocol versions, arms etc.

    These listings are also enhanced with additional new local filters for more focused data analysis.

    Subject Count by Latest Scheduled Visit – Study and Subject Count by Latest Scheduled Visit – Study/Country/Site dashboards are enhanced with a single select Arm filter.

Deep Learning Intelligent Assistant (DaLIA)

What’s New for DaLIA in LSAC 4.4: 

  • DaLIA can now handle queries regarding multiple similar intents coupled with AND/OR/BUT/NOT for following Intent
    • Adverse Events
    • Concomitant Medication
  • DaLIA Audit Trail download functionality at account level is now available under the Audit Trail section for users with admin access. 
  • DaLIA can now respond to the additions in local filters captured through user typed DaLIA queries for Disposition Events.
  • Smart suggestions: Smart suggestions will be shown on Smart clinical explorer. These suggestions are generated based on ML algorithms. Three use cases are taken in this release
    • Combination of Adverse Events & End of Treatment
    • Combination of I/E criteria and enrollment
    • Correlation analysis for output variable [Early-EOT] to  AE/Demographics
  • Maintain read status for analyzed suggestions: Users will be able to differentiate between read suggestions and unread suggestions. 
  • Users can now enable/disable smart suggestions

Clinical Data Hub

Saama’s Clinical Data Hub (CDH) provides a pipeline for submitting & visualizing patient and operational data.

What’s New for CDH in LSAC 4.4: New Features

  • Operations File browser has been introduced.
  • Actigraph Connector has been introduced as an API-based source adapter.
  • Adapters have been created and integrated into the CDH application to connect to PPD CTMS source system.
  • Stream Page Report has been introduced.
  • Operations (vendor) data can be extracted from the ODL layer.
  • Operations (vendor) data can be extracted from the CDM layer.
  • Operations (vendor) data can be extracted from the USDM layer.
  • Custom KPI dependency – Job.
  • Basic functions such as UPPER case, LOWER case, SUBSTR and others should be supported at row level operations to make development easier.
  • Keep/Drop/re-name variables should be supported at row Operations, which will reduce the load by removing un-necessary variables to transport into column level.
  • There is Adaptive Clinical Adapter support for API-based EDC and CTMS source inputs.
  • Oracle Inform EDC Adapter is now supported.
  • The Veeva Adapter supported for API-based EDC and CTMS source inputs.
  • Smartsheet adapter is supported as a source adapter in Medical Review History to support Dynamic Line Listing in LSAC
  • RAVE study alias enhancement.
  • The Data Browser now supports file downloads that contain records based on filter criteria applied.
  • Drop Zone pull job supports files of more than 1000
  • System supports the use of top layer domain to lower layer while doing the mapping.
  • Hierarchy values now support special char such as ‘,’.
  • Users can now apply filtering criteria on empty datasets.


  • Metadata export file name edited for clarity.
  • A custom KPI layer is now supported in Operations Data Browser
  • SFTP-S3 connection switch
  • GSDM structure can be updated with default columns
  • Delimited text files now support different delimiters
  • Two PDL on the Data browser
  • DLL history table shall be accessible from Data browser
  • Patient Extract job -PDL/Pre-conf/Conf update
  • Notification template has been updated to capture account details

LSAC Platform

Cross Platform Changes Primarily for Administrators:

  • A new account details tab in User Management Settings allows Account Admin users to add/edit any account level attributes such as MFA Settings, IP Settings and so on, directly from the UI. This tab also facilitates in connecting users with user groups and with other related information.
  • Admin users will be able to search users with the help of a search bar provided in the Users tab in the User Management app. Entering a specific email address in the search bar will pull up a single record in the table.
  • LSAC User Account status can be changed to Active/Inactive by a super admin user. Whenever account status is changed, an email will be sent out to all the super admin users informing them about the change in the user’s account status.
  • The existing LSAC account admin role has been renamed to User Admin in the LSAC platform.
    • The permissions for this role remain as-is. User Admins will be able to perform CRUD operations on the three tabs (Users, User Management, and Personas).
  • When setting up a new password the ‘New Password’ box will assess user inputs and will display check marks for all password conditions if they are met (ie. capital letters, special characters)
    • The Save & Next/Submit button will be enabled only when the new password meets all the necessary requirements.
  • A loader/spinner will be seen when the user clicks on the Submit button to switch to another LSAC account. The spinner indicates that backend processing is fetching the requested data.
  • A new utility will support migration of LSAC Analytics NEST Databases from Data Centers (DC) to Amazon Web Services (AWS)
    • The primary inputs for this activity are the source customer account details and the target customer account details. Since this is a database-level activity, it is important to note the time it takes to restore the target tables as they would be locked during this migration.
    • A backup of the target NEST DB is made before carrying out this activity.

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