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 proven 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 v3.7.
This section gives a list of new features and/or updates for each module worked upon or improvised.
Enhancements in Operations Insights
COM-4234: Addition of new KPI in Site Summary dashboard - Study
The addition of new KPI, Site Activation Time, gives the actual and planned activation time at site-level as well as the mean site activation time at a country-level and study-level. This helps to better assess site performance for a study.
COM-4226: Addition of new subject disposition metric in the Enrollment Funnel
The following subject disposition metrics have been added to the Enrollment Funnel widget in the ‘Enrollment dashboard – Study’ that helps the user to analyze and assess the enrollment behavior more closely. These are:
- Treatment Initiated
- Treatment Not Initiated
- Discontinued Before Treatment
- Discontinued After Treatment
- Follow up Agreed
- Follow up Not Agreed
- Withdrawal of Consent
COM-3966: Addition of a new dashboard filter in ‘Quality Measures dashboard – Study’
The addition of a new dashboard filter, namely, Protocol Deviation Severity, allows the user to sieve and retrieve data based on Major or Minor protocol deviations across all PD metrics in the dashboard.
COM-3883: ‘View By’ Month and Year enhancement in the Protocol Deviation widget in ‘Quality Measures dashboard – Study’.
Enhancement in Protocol Deviation widget for Year and Month, give an overview of major and/or minor protocol deviation count, trend over time period. The users will be able to correlate the increase in protocol deviations with the number of sites activated and the number of subject enrolled, over a period of time.
COM-4115: Addition of a new site-milestone funnel in ‘Site Activation dashboard – Study’
The addition of a new site-milestone funnel draws attention to all milestones that traverse the site activation process. These site-milestones are as follows:
- Sites Planned
- Sites Contacted
- Sites CDA Sent
- Sites CDA Received
- Sites EFQ Sent
- Sites EFQ Received
- Sites Proposed for Pre Study Visit
- Sites completed Pre Study Visit
- Sites completed Site Initiation Visit
- Sites Selected
- Sites On Hold
- Sites Cancelled
- Sites Closed
- Sites Archived
COM-4177: Site-level data is segregated into Active and Inactive buckets so that data retrieval is meaningful.
The multi-select site-level filter has been segregated into different buckets (Active, InActive and Closed) to present data on the basis of the site status selected. Users will be presented with data from all Active sites, by default*. Users can select the other buckets as needed. These buckets are described below:
- Active: All active sites
- Closed: Closed/Terminated/Archived sites
- Inactive: On Hold/Proposed/Cancelled/Candidate/Initiating/Not Participating sites
If a site is greyed out then no data is present on that site.
Scope of this feature: Site Summary dashboard and Cross Study Performance dashboard
*The 'Site Summary dashboard - Study' selects both the Active as well as the Closed site status buckets, by default.
COM-4179: Enhanced widget – Site Activation and Enrollment Over Time
The Site Activation and Enrollment Over Time widget has been enhanced to include line and bar charts to assess site activation and enrollment progress for a study across all sites. The coupling of site activation and enrollment behavior in a single widget encourages deep analysis into the various factors affecting activation and enrollment progress on a monthly/time period basis.
COM-4123: Redesigned dashboard – Cross Study Performance - Site
The dashboard ‘Site Specific Performance – Site’ has been redesigned and renamed to ‘Cross Study Performance – Site’. An active site can be assessed on the basis of data retrieved from several KPI metrics that are accessible through the Metrics Name dropdown.
COM-4457: Design Improvement – Portfolio Summary dashboard
The Program/Study/Phase column has been renamed to Group. Cohort level information, for recruitment, will be fetched from the ‘cohortplannedrecruitment’ USDM table. The tooltips (denoted by i symbol) has been added to some columns. The tooltip shows the logic/calculation driving the various KPI metrics. These KPI columns are as follows:
- Enrollment Rate (subject per site month)
- Enrolled: Actual/Planned to Date
Enhancements in Clinical Insights
COM-4131: Enhancements in Lab Spaghetti Plot – Absolute Value – Patient Profile
The Lab Spaghetti Plot – Absolute Value – Patient Profile has been enhanced to support multiple lab tests. Each lab test presents itself as a separate widget where the user can see the lab test results for multiple subjects. Some highlights of this functionality are:
- Users can view data based on Study Days or Visit Schedule
- Users can zoom in to look closely at the graph data
- Baseline visits are represented as hollow symbols, to distinguish them from the rest of the visits.
Enhancements in the USDM Data Model
COM-4589: Addition of column name ‘visitid’ in the USDM table, namely, tva – Trial Visits per Arm
The column name visitid has been added into the USDM table, namely, tva – Trial Visits per Arm and has been marked as a primary key column, along with the other primary key columns, namely, studyid and armcd.
COM-4309: Addition of four new USDM tables to take in AE and Oncology Tumor Assessments at site-level and country-level.
The USDM Data Model has been expanded to include the following new tables to support AE, Oncology, and Tumor assessments at site-level and country-level. These tables are:
- studyproduct - Study Product
- studycountry - Study Country
- std_sitecountrycode - Standardized Table for Countries and its Country Code
- cohortplannedrecruitment - Cohort Level Planned Metrics
- cohortmilestones - Cohort Level Milestones
- death - Death Domain
New columns have been added to the following existing tables to support site-level and country-level queries. These tables with their respective column additions are as follows:
- study - Studies: One ew Column - sub_ta
- subject - Subjects: One new column - protver
- dv - Protocol Deviations: One new column - dvcls
- ae - Adverse Events: One new column - aeepreli
- dm - Demographics: One new column - brthdtc_iso
- lb - Lab Data: One new column - timpnt
- sitemilestone - SiteMilestones: Two new columns - iskeymilestone, endmilestonecycletime
- countrymilestone - Country Milestones: Two new columns - iskeymilestone, endmilestonecycletime
- tv - Study Visit Schedule: One new column - isbaselinevisit
- tva - Trial Visits Per Arm: Two new columns - visitid, visitnum
The following bug has been fixed for LSAC release v3.7:
Milestone names that contain zero/null data are not shown in the Milestone Cycle Time Graph widget in the Site Activation dashboard – Study.
There are no known issues for this release.
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: email@example.com