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 4.2.1 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

The LSAC CDH application, as part of the LSAC CDHv4.2.1 release, has been improvised through the resolution of high severity issues.

Abbreviations & Acronyms

     The list of applied acronyms and abbreviations is mentioned below:


    

TermDefinition
LSACLife Science Analytics Cloud
CDHClinical Data Hub
PDA/PDLPatient Data Analytics/Patient Data Layer
ODLOperation Data Layer
ODM
Operational Data Model
EDCElectronic Data Capture
CDL/CDMCommon Data Layer/Common Data Model
Medidata Rave
Cloud Based Clinical Data Management System
BioStat
Biology & Medical Statistical Software
DQData Quality
CTMSClinical Trial Management System
AWS
Amazon Web Services


New Features/Enhancements in LSAC Analytics

     There are no new enhancements or features as part of the LSAC CDHv4.2.1 release.

Bug Fixes

The fixed issues, as part of the LSAC CDHv4.2.1 release, are listed as follows:


Issue ID

Issue Description

Resolution

PDA-8690

              

Stream_pagestatus and stream_querydetails is missing from the rave_biostat job due to syntax error.

Resolved. The stream datasets will get loaded and will be visible in the CDH datasets/database for all projects.

PDA-8605Rave EDC job status is showing as 'Pass' when a failed authentication (wrong credentials) occurs. The content of the email is incorrect for a failed BioStat (Rave)  jobResolved. The BioStat job status has been rectified.


Known/Open Issues

The deferred issue, as part of the LSAC CDHv4.2.1 release, is listed as follows:


Issue ID

Issue Description

Status/Workaround

PDA-8725

              

When a Rave-ODM job fails, the status and notification format sent out is incorrect.

Deferred. This will be taken up in the LSAC CDHv4.5 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