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 4.5.1 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 v4.5.1 is a patch-fix release that states the resolution status for the high-priority bugs reported post the LSAC v4.5 release.

Abbreviations & Acronyms

     The list of applied acronyms and abbreviations is mentioned below:


    

TermDefinition
LSACLife Science Analytics Cloud
CDHClinical Data Hub
CIClinical Insights
OIOperations Insights
DaLIADeep Learning Intelligent Assistant
PDA/PDLPatient Data Analytics/Patient Data Layer
OOBOut of the Box
SSOSingle Sign On
MSFMaster Study Filter
KCLSAC Key Cloak Server, that is, the Authentication Server that stores user information
ODLOperation Data Layer
EDCElectronic Data Capture
CDL/CDMCommon Data Layer/Common Data Model
DQData Quality
CTMSClinical Trial Management System
PPPatient Profile Focus area in application
USDMUnified Study Data Model


New Features/Enhancements in LSAC Application

There are no new enhancements as part of the LSAC v4.5.1 release.


    Bug Fixes

1

The bug fixes, as part of the LSAC v4.5.1 release, are listed as follows:


Issue ID

Issue Description

Resolution

COM-9724

Hy’s Law Dashboard is not reflecting data for any of the studies

Resolved. Working as expected

COM-9636

The Planned Country count is not visible in the Site Activation & Enrollment widget in Study tab in Executive Summary Dashboard.

Resolved. The widget is showing planned and actual country counts.

COM-9615

The new column LPLV in Oversight Scorecard is showing incorrect values and other values are not aligned under the correct column.

Resolved.

COM-9610

The Query by Study widget in Study tab of the Executive Summary dashboard is showing inconsistent counts and some of the summary cards are misspelt.

Resolved. The data from Query by Study widget is matched with data from the Aging table on the right. The summary cards are spelt correctly – Open and Aging.

COM-9608

The filter values in search boxes of Arm, Country, and Site are not in chronological order.

Resolved. 

COM-9607

The Protocol Version summary card in Study tab of the Executive Summary dashboard does not enlarge and the list of protocol versions used are not displayed in most-recent order of use.

Resolved.

COM-9599

The Study Details and Study Milestones widget tables in Study tab of the Executive Summary dashboard show blank fields at the end.

The widget tables, namely, Study Details and Study Milestones do not show blank values. This issue is resolved.

COM-9597

The PDF export of the Executive Summary dashboard had missing widgets.

This issue has been resolved to include the widgets, namely, 

  1. Distribution by Phase
  2. Distribution by Program/Compound
  3. Distribution by Indication

COM-9594

The data appeared distorted in the widgets in the Study tab of the Executive Summary dashboard.

This UI issue is resolved.

COM-9583

The scroll bar included in the tooltip of the widgets in GPP is displayed outside the tooltip.

This UI issue is resolved.

COM-9580

The date and time data displayed in the tooltip of the Exposure widget in the GPP dashboard is not aligned and takes up 2 rows.

This UI issue is resolved.

COM-9577

The multiple unscheduled visits are not aligned with the previous visit date and are showing past visit dates.

Resolved.

COM-9576

The Enrollment Rate widget in the Executive Summary dashboard is showing every individual enrollment rate without any categorization.

Resolved. This issue is resolved to show enrollment rate indicative of the rate and the category into which it falls.

COM-9617

The data in the tooltips in the various widgets of GPP is not aligned with its corresponding label.

This UI issue has been resolved.

COM-9574

The Smart Suggestions box is not popping up for all the client accounts when the SCE dashboard is loaded.

Resolved.

COM-9572

The Primary Endpoint widget data in the Executive Summary dashboard is not able to handle large data.

This UI issue is resolved to show text in continuation when the user clicks on More.

COM-9569

The tooltip data is not visible for the Days Ahead KPI in the Study Milestones widget in the Study tab of the Executive Summary dashboard.

Resolved. Issue has been resolved to show missing data.

COM-9565

The indicative percentage for a complete load of data should be 100% and not more than 100% in the Subject Visit Tracker widget of the Subject Visit dashboard.

This issue is resolved to show 100% when the complete data is loaded in the Subject Visit Tracker widget.

COM-9563

The data is not aligned to the corresponding columns in the Enrollment by Arm/Cohort widget of the Executive Summary dashboard.

This UI issue has been resolved.

COM-9561

Subject data corresponding to screen failure is being displayed across lab charts in Patient Profile dashboard.

This issue has been resolved to not include data of subjects with screen failure in lab charts.

COM-9560

The Key KPIs widget in the Executive Summary dashboard is not displaying data.

The data is being displayed in the Key KPIs widget as expected.

COM-9559

There is no data tooltip displayed when the user hovers over the bar in the Gantt chart in the Study Milestones widget in the Study tab of the Executive Summary dashboard.

Resolved.

COM-9555, COM-9553

Incorrect data is being displayed in the summary cards - Subjects with Partial Response & Subjects with Progressive Disease in the Patient Profile dashboard.

Correct data is being displayed in both widgets.

COM-9552

The Freeze columns functionality is not working correctly in the Study Details widget of the Executive Summary dashboard.

The Freeze Columns functionality is working as expected and all the columns marked Freeze appear in the leftmost part of the widget table.

COM-9618

There are multiple line charts depicting Vital Signs data for a subject in the GPP dashboard.

A single line in the Vital Signs widget is indicative of vital signs data for a subject.

COM-9623

Data mismatch in the Distribution by Study Life Cycle widget of the Executive Summary dashboard.

Resolved.

COM-9520

The graph line in the Changes from Baseline SOD widget in the Solid Tumors tab of the SCE dashboard does not follow the assessment number.

Resolved.


Known/Open Issues

There are no open/deferred issues as part of the LSAC v4.5.1 release.

Technical Support

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