Purpose & Scope

Life Science Analytics Cloud (LSAC) suite of applications is the leading AI-powered clinical analytics self-serving platform from Saama that seamlessly integrates and processes 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 that sponsors and CROs can optimize study planning, enrollment, compliance, productivity, and oversight.

The purpose of this document is to provide the release notes for version 4.4 of LSAC application. The release notes review the latest enhancements/new features of the LSAC application along with addressing known defects and fixed defects. 

This document is intended to leave the business user with an understanding of the features and fixes to the LSAC application when upgrading from subsequent versions.

Release Summary

This release, LSAC v4.4, focuses on the new features/enhancements in LSAC Analytics that will aid in providing business users with unique ways to interact with their data and will also help data analysts to drive the best analytical experience for their data-driven business decisions.

For this release:

• The analytics tab, Clinical Insights has introduced a new tab in SCE dashboard along with some new listings and other key enhancements in GPP, CI dashboards. 
• There are several key enhancements in the analytics tab, Operations Insights. 
• There are new administration roles and new administration tabs introduced in LSAC Platform along with some enhancements.
• There are new suggestions in Saama DaLIA along with some new combined AE intents.
• There are new source adapters introduced in LSAC CDH (v3.2) along with some new OOB functions.

The features/enhancements are categorized for better understanding and assimilation.

Operation Insights

Enhancement! Listings – Subject Visit & Latest Subject Visit

The following new columns have been added to two listings, namely, Latest Subject Visit listing in focus area: Subject and Subject Visit listing in focus area: Site. These columns have been added to view data for multiple arms, study phases, protocols and so on. These are:

• Arm
• Protocol Version
• Baseline Visit
• Study Phase
• Compliance Tracking

The following multi-select local filters have been added to the listings to gain a more focused result.

These are: 

• Study Name
• Site Identifier
• Arm
• Study Phase
• Visit
• Baseline Visit
• Compliance Tracking

Enhancement! Dashboard – Subject Visit Compliance with Schedule – Study & Subject Count by Latest Scheduled Visit (Study/Country/Site)

New local filters have been added to the Subject Visit Compliance with Schedule dashboard – Study & Subject Count by Latest Scheduled Visit dashboard – Study/Country/Site to render data in all widgets based on selected arm. The Arm filter is non-mandatory, and its values are dependent on the study selected in the Master Study Filter (MSF). 

Enhancement! Widget – AE/SAE Trend in Safety Summary dashboard

The widget AE/SAE trend in the Safety Summary dashboard – Study has been enhanced to show the progression of Cumulative Enrollment Count over a monthly timeline, for every active enrolling month or for a period of time, until the LPO/LPLD/LPLV date is collected.

The Cumulative Enrollment Count will be seen in the tooltip (when the user hovers over a data marker) only when it is activated in the legend key for a Monthly analysis done through the Month tab in AE/SAE Trend widget.

The Cumulative Enrollment Count is inclusive of data seen in the tooltip (when the user hovers over a data marker) at any given time point in the timeline presented through the Time tab in AE/SAE Trend widget.

Enhancement! Mandatory filters with default value

To avoid loading of an empty dashboard, the local/global filters of the following dashboards have been modified to mark the mandatory filter(s) with a red asterisk and to render data, based on a system-selected value in the mandatory filter, when the dashboard is selected.  The filter value is the first selection of an alphanumerically or alphabetically sorted list of values in the mandatory filter. 

Note: The default value in the mandatory filter will be applied as per the user defined access to the LSAC application.

Operation Insights

• Site Activation dashboard (Study) - Filter - Study Name
• Enrollment Dashboard (Study) - Filter - Study Name
• Safety Summary Dashboard (Study) - Filter - Study Name
• Quality Measures Dashboard (Study) - Filter - Study Name
• Data Metrics Dashboard (Study) - Filter - Study Name
• Study Summary Dashboard (Study) - Filter - Study Name

Enhancement! Saving UI Configurations

The following UI changes carried out on widget tables & widget listings found in certain OOTB dashboards*, will be saved by the application at an account level for subsequent logins, until these changes are revisited and modified by the user with Admin access. These changes that can be performed on widget tables & listings are:

• Freeze/Un-freeze columns
• Hide/Un-Hide columns
• Sort Column Values
• Collapsed/Expanded rows (Applicable to Site Summary dashboard & Portfolio Summary dashboard)

*The widget tables & listings applicable are contained in the following dashboards: (OI) Portfolio Summary, Site Performance - Study, Site Summary - Site, Site Activation – Study, Enrollment dashboard – Study, and (CI) Smart Clinical Explorer (SCE) dashboard.

New! Archiving Un-used/Deprecated Analytics

A folder or archive storage, namely, LSAC OOTB Library, has been created to house or contain any analytics that appear deprecated. This library will be accessible only to the Saama implementation team for any future reference/configuration purposes.

New! Customized display name for dynamic filters

Admin users will be able to specify the display names for OOB filters and for any newly added custom filters through the Edit Analytics UI. This feasibility will allow the CS teams to carry out customizations without giving rise to any complications between UI display name and CQS schema name. API as well as UI changes will be required for a successful process run.

New! DAG access to Non – CQS Schema

The CQS query in non-CQS schema should automatically add the DAG-based studies as filters.

Enhancement! Subject Compliance Logic

The Subject Visit Compliance logic has been enhanced to take in ‘Expected subject visits in a future date’ in the following manner: If the expected visit date is after the current date and the Window Closed date has not yet been reached/ Projected achieved, then this visit will be marked as instead of Missed as the expected date has not been reached.

Enhancement! KPI Logic modified

The KPI logic has been modified to show the correct values of Subject Compliance KPIs in the tooltips of Oversight Scorecard (Study/Site).

JIRA IDs applicable to the above stories in OI are: COM-6987, 7035, 7002, 7003, 3348, 5383, 5137, 5519, 6575, 7930, 7931, 7932, 7004, 8104

Clinical Insights

New! Medical History (MH) tab in Smart Clinical Explorer (SCE) dashboard

The addition of the MH (Medical History) tab in the SCE dashboard gives insights into various components of a study associated with medical history. The MH tab is divided into various components that allows users to assess certain metrics and fetch relevant details. These components are:

• MH - Summary Cards: These provide a quick summary or overview on certain statistics associated with medical history, for a study/arm.
• MH - Medical History widget: This provides the count and percentage of subjects associated with each MH Coded Term for every MH Body System Term from a spool of screened subjects for a study/arm.
• MH - MH Listing - This widget listing provides the demographic details as well as the MH details of subjects associated with medical history.

The MH components (Summary Cards & Widgets) can be selected to be part of the filter story that can be applied across all SCE domains.

Enhancement! Mandatory filters with default value

To avoid loading of an empty dashboard, the local/global filters of the following dashboards have been modified to mark the mandatory filter(s) with a red asterisk and to render data, based on a system-selected value in the mandatory filter, when the dashboard is selected.  The filter value is the first selection of an alphanumerically or alphabetically sorted list of values in the mandatory filter. 

Note: The default value in the mandatory filter will be applied as per the user defined access to the LSAC application.

• Lab Spaghetti Plot – Absolute Value (PP) - Filters: i) Study Name, ii) Lab or Examination Name
• Lab Spaghetti Plot – Baseline (PP) - Filters: i) Study Name, ii) Subject Identifier
• Graphical Patient Profile (PP) - Filters: Subject Identifier
• Subject Progression (PP) - Filters: i) Study Name, ii) Site Name
• Adverse Events - Toxicity Profile (Study) – Filters: i) Study Name
• Adverse Events - Reporting Delay (Study) – Filters: i) Study Name, ii) Site Name, iii) Site Country

New! OOB Listings in Clinical Insights

The following OOB Analytics listings have been added to the CI domain. These are:

• Exposure
• Vital Signs
• Medical History
• Electrocardiogram

Enhancement! USDM changes for application feature Graphical Patient Profile (GPP)

The following USDM changes have been made to support the application feature GPP. New columns have been added to the following tables as stated below:

• tablename: ECG Test Results: Columns added - i) egtimpnt - EG Time Point, ii) egstnrlo - Reference Range Lower Limit in Standard Units, iii) egstnrhi - Reference Range Upper Limit in Standard Units.
• tablename: Exposure: Columns added - i) exacn - Action taken with Study Drug, ii) exreason - Reason for Dose Modification
• tablename: Medical History: Columns added - i) mhsev - MH Severity, ii) mhongo - MH Ongoing
• tablename: Vital Signs: Columns added - i) vstimpnt - VS Time Point, ii) vsstnrlo - Reference Range Lower Limit in Standard Units, iii) vsstnrhi - Reference Range Upper Limit in Standard Units.

JIRA IDs applicable to the above stories of CI are: COM-6639, 6746, 5701, 5702, 5703, 5704, 5705, 5706, 5711, 5713, 5715, 5716, 5381, 5588, 6826, 7283, 7488

Smart Search Powered by DaLIA

New! Suggestion – EOT & SAE

The aim of this suggestion is to highlight the abnormalities in count of SAE and early EOT. The new suggestion shows the count of EOT (End of Treatment) which are due to SAE (Serious Adverse Events). 

New! Suggestion – I/E Criteria and Enrollment

The aim of this suggestion is to show the count of subjects who have not met the screening criteria but still got randomized. 

New! Suggestion – Parameters impacting EOT

The aim of this suggestion is to show the correlation between the input and output parameters. The input parameters indicate the cause, that is, AE, Exposure Drug, Demographics. The output parameters indicate the effect, that is, Early EOT.

New! Ability to disable/enable DaLIA suggestions

The user will be able to disable/enable DaLIA suggestions. When disabled, the count of suggestions will not be visible, and the icon will be greyed out but will still be visible.

In the event, when there are no suggestions to show, the DaLIA suggestion icon should be visible to the user and clicking on it should show the message, “No Smart Suggestion detected based on current data”.

A cross icon shown at the bottom right corner of the suggestion box allows the user to minimize or collapse the DaLIA suggestion window.

By default, the DaLIA suggestions window will be active and visible in the Smart Clinical Explorer dashboard.

New! Read/Un-Read DaLIA Suggestions        

An analyzed or read suggestion will be shown in a different color and the user will be able to differentiate between an un-read suggestion and a read suggestion by looking at the color of the suggestion.

The count of suggestions that appears on the DaLIA suggestion window indicates the count of un-read suggestions.

The log in session will not impact the analyzed or read suggestions.

New! Renaming of DaLIA suggestions

The DaLIA suggestions popup has been renamed to Smart Suggestions.

New! DaLIA Log Reports

An LSAC admin user will be able to see the list of queries that have been typed by users with ‘Basic’ access to the system. A log of all queries will be stored, irrespective of whether the query had a response or not and will be visible to all users with admin access. All query logs will appear in the DaLIA Audit Trail Report. The data log generated can be downloaded as a CSV file.

JIRA IDs applicable to the above stories in DaLIA are: COM-6727, 6769, 7202, 7056, 7162, 7164, 7172, 7191, 7203, 7206

LSAC Platform

Enhancement! Change of name of existing application tab - User Management

The existing application tab User Management that is accessible from under Administration module, from the platform left navigation bar, has been renamed to Account Management.

New! New tab – Account Details in Account Management

An advanced admin user, that is a user with an Account Admin role, will be able to access the new tab, namely, Account Details in Account Management (formerly known as User Management). This will allow the admin (having necessary permissions) 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.

Users with the Account Admin role will be able to see a new tab Account Details in the User Management module and will be able to make changes to some account level attributes. 

The Account Admin users can make the changes to:

• Display Name
• MFA Settings
• IP CIDR Settings
• Terms and Conditions

New! New Role – LSAC Admin 

A new role, LSAC Admin, has been introduced that will give a user, with Super Admin permissions, access to all LSAC applications, LSAC accounts and some of its configurations. The LSAC admin role will be for Saama internal users only.

The All Accounts tab will be visible only to the LSAC Admin user account, where all accounts will be managed from a centralized place. The following operations can be performed by an LSAC admin through the All Accounts tab:

• View/Edit all LSAC accounts from a single place.
• View all LSAC Accounts related metadata from a single screen such as Account Name, Created On, Account Admin information and so on.
• Add a new LSAC Account
• Turn the flag as Active/Inactive for any LSAC account.

Enhancement! Migration of LSAC Accounts

All of the LSAC accounts and their attributes will be migrated to the Key Cloak server (the LSAC authentication server) and will be rendered from the KC server to the Account Management module UI in the LSAC application.

New! Visibility of All LSAC Accounts

The LSAC Admin account, held by a Saama internal admin user, will be the only account that will have access to the All Accounts tab. LSAC accounts can be viewed/modified and new LSAC accounts can be added from the All Accounts tab.

New! Search Users

An admin user will be able to search users with the help of a search bar provided in the Users tab in Account Management (formerly known as User Management). The search bar is sensitive and responds to every character input and delivers all results that match the user input. Entering a specific email address in the search bar will pull up a single record in the table.

New! User Account status email

The LSAC User Account status can be changed to Active/Inactive by a super admin user. Whenever the account status is changed, an email will be sent out to all the super admin users informing them about the change in the user account status.

When the status of an LSAC user account changes to Inactive, then all user attributes mapping of the existing user will be deleted for the updated LSAC account.

Enhancement! Rename Existing Role Account Admin to User Admin

In lieu of the new feature, namely, Account Management, the existing LSAC account admin role has been renamed to User Admin in the LSAC platform. The permissions for this role remain as-is, that is, the user with the User Admin role will be able to perform CRUD operations on the three tabs, namely, Users, User Groups, and Personas.

Enhancement! New Password Create/Update process

In the scenario of setting up a new password, such as, 

• When a new user is setting up his/her password for the first time
• When an SSO user is changed to a non-SSO user

the New Password box will be sensitive to assess user inputs and will be able to verify if the new password characters are aligned with Saama’s password policy. Every necessary password requirement/condition will be check marked as the user types the new password and this will be indicated through a tooltip that will be visible to the user. 

The Save & Next button or the Submit button will be enabled only when the new password meets all the necessary requirements/conditions. 

New! LSAC Account Switch process indicator

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 being done by the application to fetch the requested data.

New! Utility to migrate LSAC Analytics NEST DB from DC to AWS

A provision has been made to migrate LSAC Analytics NEST DB from Data Center (DC) to 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. 

Before carrying out this activity, a backup of the target NEST DB is taken. 

JIRA IDs applicable for the above stories in LSAC Platform: LSPT-1414, 1734, 1735, 1737, 1804, 1808, 1809, 1555, 1562, 1726, 1736, 1745, 1776, 1822, 1828, 1829, 1830

KPI Studio

Enhancement! Subject Visit - Listing

The Subject Visit – listing has been enhanced with additional fields and filters to accommodate clinical trials where the treatment period repeats in cycles/phases/periods. The following attributes have been added to the listing, as new columns and as new local filters:

• Arm
• Protocol Version
• Study Phase
• Baseline Visit
• Compliance Tracking

Users can add or remove any column from the listing, as required.

Enhancement! Dashboards - Visit Compliance & Subject Visit Compliance 

The dashboards - Subject Visit Compliance & Visit Compliance have been enhanced with additional fields and filters to accommodate clinical trials where the treatment period repeats in cycles/phases/periods. The following attributes have been added to the listing, as new columns and as new local filters:

• Arm 
• Protocol Version

The filters, Arm and Protocol Version, are dependent on the values in the Study filter.

Users will be able to add or remove any local dashboard filter except the Study filter. All the widgets, listed below, that are part of the Subject Visit Compliance dashboard will render data based on the value selection in the dashboard filters. These are:

• Visit Compliance Summary Card
• On-Schedule Visits Over Time widget (Bar Chart)
• Compliance with Schedule by Visit (Stack Chart)
• Subjects by Latest Scheduled Visit

The dashboard can be drilled down to navigate to Subject Visit – listing and to Latest Subject Visit – listing. The PLO tables have been updated to generate visit schedule and to calculate metrics based on the values from the column baselinevisit instead of visitdy from TVA table.

Enhancement! Latest Subject Visit - Listing

The Subject Visit – listing has been enhanced with additional fields and filters to accommodate clinical trials where the treatment period repeats in cycles/phases/periods. The following attributes have been added to the listing, as new columns and as new local filters:

• Arm
• Protocol Version
• Study Phase
• Baseline Visit
• Compliance Tracking

Users can add or remove any column from the listing, as required.

JIRA IDs applicable for the above stories in LSAC KPI Studio: COM-7038, COM-7108, COM-7110, COM-7036

Clinical Data Hub (CDH v3.2)

Enhancements

• Updated the metadata export filename to metadata_<dataset>_version_datetime format.
• Custom KPI layer is now supported in Operations Data Browser.
• User will be able to switch the connection from S3 to SFTP for the vendor.
• GSDM structure can be updated with default columns.
• Delimited text file now supports different delimiters.
• Users will see a single PDL layer if there is one EDC source configured in the application.
• DLL History table shall be accessible from Data Browser.
• User will be able to provide the parameters for the PDL/Pre-Conformance/Conformance extract job.
• Notification template has been updated to capture account details.

New Features

• Operation 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 stream.
• 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.
• 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.
• A single Drop Zone pull job supports more than 1000 files.
• System supports the use of top layer domain to lower layer while doing the mapping. 
• Hierarchy values now support special char such as ‘,’. 
• There is the ability to apply the filter criteria when the dataset is empty.

JIRA IDs applicable for the above stories in CDH (Clinical Data Hub): PDA-7685, PDA-7683, PDA-7670, PDA-7665, PDA-7664, PDA-7661, PDA-7660, PDA-7646, PDA-7321, PDA-7657, PDA-7658, PDA-7185, PDA-7183, PDA-7182, PDA-7179, PDA-7178, PDA-6983, PDA-6920, PDA-7648, PDA-7125