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 v4.2.3.
New Features/Enhancements
This release is a minor release that is defined by the addition of a new tab in the SCE dashboard and a few enhancements done in the USDM domain of the LSAC product. A few bug fixes align the product with its delivery scope.
This section below gives a list of the new features/enhancements for each module worked upon or improved.
Acronyms & Definitions
| Term | Definition |
|---|---|
| CI | Clinical Insights |
| OI | Operations Insights |
| SCE | Smart Clinical Explorer dashboard in CI insights |
| CM | Concomitant Medication |
| AE | Adverse Event |
| KPI | Key Performance Indicator |
| CDH | Clinical Data Hub |
| DaLIA | Deep Learning Intelligent Assistant |
| LSAC | Life Science Analytics Cloud |
| EDC | Electronic Data Capture |
| IDP | Identity Provider |
| USDM | Unified Study Data Model |
df1
Enhancements in Clinical Insights
COM-7256: New! Addition of Labs domain in SCE dashboard
The SCE dashboard has been enhanced with a newly added tab, namely, Labs tab. The Labs tab provides an elaborate account of subject response at every study visit (scheduled & unscheduled) for each of the subjects participating in a clinical trial. The lab widgets provide graphical as well as tabular views of data.
Enhancements in USDM Data Model
COM-6567: Enhancement! New columns have been added to existing database tables
1
The following tables in the USDM data model have been enhanced to enable the product to identify the appropriate visit schedule for subjects based on the cohort/treatment phase/any other conditional applicable based on the protocol version.
- USDM table: tva - Trial Visit per Arm
- Column: visit_schedule_code (not null)
- Column: visit_schedule_desc (not null)
- Column: protver (not null)
- Column: studyphase (not null)
- Column: compliance_flag (not null)
- USDM table: subject - Subjects
- Column: visit_schedule_code (not null)
- Column: visit_schedule_desc (not null)
- Column: protver (not null)
- Column: arm
- Column: armcd
Bug Fixes
The following issues have been fixed as part of the LSAC v4.2.3 release:
| JIRA ID | Expected Results |
|---|---|
COM-7275 | The first record of SOC data, from data source, is visible in AE Subject Count widget under AE tab in SCE dashboard. |
COM-7183 | The AE Subject Count does not show infinity in count and percentage in summary card column. |
COM-7255 | The data in AE Subject Count widget is sourced from the AE Term column and the user will be able to see data even if the data is not mapped to the Preferred Term column. |
COM-7213 | After logging into LSAC, the user can see the LSAC Home Page and there are no error messages displayed. |
COM-7042 | Screen Failure % value as seen in the summary card and Enrollment Funnel widget are now consistent. The percentage logic for other disposition events as seen in the Enrollment Funnel widget is modified. |
COM-7296 | Drilling down on the bars in Adverse Events by Body System widget, in Safety Summary dashboard - Study, displays the categorized AE count and not the value zero. |
LCDR-273 | The Add Task option is visible by clicking the More icon that appears at the top right corner of the legacy dashboard, here, Study Summary dashboard - Study. |
COM-7253 | The count for the metric Actual Site Activation (Monthly/Cumulative) is not shown, in the Site Activation and Enrollment Over Time widget, if data is not present for it. |
Known Issues
These are the following open issues as part of the LSAC v4.2.3 release:
| JIRA ID | Bug Description |
|---|---|
LSAC Analytics | |
COM-7573 | The count of ‘Serious and Unrelated’ AEs, for the category Gastrointestinal Disorders, seen on the bar chart is not consistent with the count seen in the pop up when the user clicks on the bar in the Adverse Events by Body System widget in the Safety Summary dashboard-Study. |
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