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 4.3.1 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 CDH v4.3.1 release, has been enhanced to populate 'stream_querydetails' data in the RAW PDL layer from the source EDC (which is RAVE).
Abbreviations & Acronyms
The list of applied acronyms and abbreviations is mentioned below:
| Term | Definition |
|---|---|
| LSAC | Life Science Analytics Cloud |
| CDH | Clinical Data Hub |
| PDA/PDL | Patient Data Analytics/Patient Data Layer |
| ODL | Operation Data Layer |
| ODM | Operational Data Model |
| EDC | Electronic Data Capture |
| CDL/CDM | Common Data Layer/Common Data Model |
| Medidata Rave | Cloud Based Clinical Data Management System |
| BioStat | Biology & Medical Statistical Software |
| DQ | Data Quality |
| CTMS | Clinical Trial Management System |
| AWS | Amazon Web Services |
New Features/Enhancements in LSAC Analytics
There are no new enhancements as part of the LSAC CDH v4.3.1 release.
Fixed Issues
The following issues have been fixed as part of the LSAC CDH v4.3.1 release.
Issue ID | Issue Description | Resolution |
PDA-8793 | Rave_biostat adapter needs to read and write the source data as it is, into the stream_querydetails dataset without dropping any patient record. This check is applicable to all clinical and operational datasets. | The Rave_biostat adapter is working as expected for stream_querydetails table. The table is populated with the EDC data without any data mismatch. Biostat adapter in CDH is also verified for other datasets and data load is working as expected. Reports are also verified. |
PDA-8867 | The Rave_biostat adapter was not pulling other biostat clinical datasets for studies that have space (‘ ‘) in the Study Alias field. This is a rare scenario but it was impacting one study in the CDH portfolio. | This issue was identified and planned as a patch fix and is resolved with this release. The Rave_biostat adapter data pull is working as expected; irrespective of the naming convention followed in the Study Alias field. |
Known/Open Issues
There are no known (deferred) issues as part of the LSAC CDH v4.3.1 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