New features to LSAC applications are available in the latest 4 series release. LSAC 4.1 delivers improvements to GPP and Subject Progression Dashboard in Clinical Insights, redesigns and enhancements to six Operations Insights dashboards, and new intents and query responses in DaLIA. Want updates in video form? Watch the 4.1 updates here.
Timely, targeted analytics in Operations Insights enable executives, study managers, and CRAs to monitor and optimize key operational metrics across a portfolio of clinical studies.
What’s New for Operations Insights in LSAC 4.1:
Redesign: Site Performance (Study Level) Dashboard
- A new look and feel for the entire dashboard matches other updated Operations Insights dashboards.
- Users will be able to see different KPIs as separate tabs.
- Graphical depictions of KPIs make it easy to evaluate the performance of a particular KPI for all sites.
- Users will be able to sort data by country of interest; summary card information will update accordingly based on user-selected study and country.
- Sites are sorted by KPI performance.
- Graphical and tabular views of KPI performance present information densely, and allow for deep dives into data.
- Users will be able to download the dashboard as a PDF and tabular site data (complete) as a CSV.
Enrollment Count/Enrollment Rate Calculation Changes
- Enrollment Rate calculation will stop/freeze when LPLD is achieved
- Information related to enrollment lock date will be available on tooltip
- Logic changes have been made to the following dashboards or widgets:
- Portfolio Summary (Focus: Portfolio) (KPI: Enrollment Rate)
- Study Summary Dashboard (Focus: Study) (Widget: Site Activation and Enrollment Over Time)
- Site Activation Dashboard (Focus: Study)(Widget: Site Activation and Enrollment Over Time)
- Quality Measures Dashboard (Focus: Study) (Widget: Protocol Deviations, View by Month and Year)
- Site Summary (Focus: Site) (KPI Enrollment Rate)
- Site – Cross Study Performance (Focus: Site) (KPI Enrollment Rate)
- Site Performance – Study (Focus: Study)
- Subject Enrollment Rate – Study/Country/Site
- LPLD and LPLV milestone details (new columns) added in Enrollment Rate Listings and in Oversight Scorecard.
Added attributes ‘Site FPFV’, ‘Site Status’ and ‘PI email Id’ to all dashboards where site details information is provided
- Oversight Scorecard – Scorecard Site: Site details on tooltip after hovering over Site ID-Name
- Oversight Scorecard – Listing View: Add new columns for Site FPFV and Site Status after Site Name column
- Cross Study Performance: FPFV, Status, and PI Email added under Site details (Flip tile) at KPI info tile
- Site Summary: Information in Site details as a dropdown from site Id
- Site – Listing: Addition of a new column for PI email
Site Summary Dashboard Enhancements
- Dashboards will be interactive to users with Lazy Loading.
- Users will be able to use the Global Filter to select study of interest.
- Selecting the local study filter is no longer mandatory.
- Tooltips for all the KPIs are added at Site/Country/Study levels.
- Added local filters for Country & Site.
Site – Cross Study Performance Dashboard Enhancement
- UX change with respect to Data Unavailability – the KPIs with no data to render will be grayed out.
Site Activation Dashboard Enhancement
- Users will be able to configure site status in Site Startup Funnel widget as required.
- Three new statuses have been added to the list of site statuses:
- Enrollment Open
- Active – No Longer Recruiting
Medical, Safety, and Compliance personnel can quickly review patient demographic information, lab data, adverse events, and concomitant medications to discover trends and patterns with Clinical Insights.
What’s New for Clinical Insights in LSAC 4.1:
New view by option for ‘Study days’ has been added to the following dashboards:
- Lab Spaghetti – Baseline
- Subject Event Log
- Subject Progression Dashboard
- Safety Summary Dashboard
Subject Progression Dashboard Enhancements
- New: Drug response display for subjects
- Added dosing end date on tool tip
- Added reason for withdrawal on tooltip where subject has withdrawn
Graphical Patient Profile Dashboard Enhancements
- AE swim lanes will now show the AE severity change overtime
- Users will be able to add a date range for viewing GPP data
- Users will be able to see withdrawal reason details in the GPP dashboard (Death Details)
- New UI feature: users can pinch and zoom to the chart area of interest
- The ‘Exposure’ swim lane has a customizable y-axis
- Customizable infographics display subject information of interest
DaLIA (Deep Learning Intelligent Assistant)
LSAC Smart Search is powered by Saama’s proprietary Deep Learning Intelligent Assistant (DaLIA). DaLIA’s been training hard since she was introduced almost a year ago and has strong new functionalities that provide better insights to plain text trial questions.
What’s New for DaLIA in LSAC 4.1:
- DaLIA now outputs charts for certain adverse event queries
- A Stacked column chart with trend line will show the trend of Adverse events over time (example video here)
- A Pie chart/donut chart will show the composition of various categories of Adverse events.
- A new tabular output format allows users to freeze rows/columns at their discretion, and large tables have search bars in individual column headers for improved filtering (for example, users can search for a specific site name when looking at AE’s by cohort in a DaLIA table).
- Therapeutic Area, Indication, Program, and Site Name search options have been added to all DaLIA intents.
- DaLIA now supports queries on the subject dispositions added in LSAC 3.7
- Follow up agreed
- Follow up not agreed
- Treatment initiated
- Treatment not initiated
- Discontinued before treatment
- Discontinued after treatment
- Withdrawal of consent
- New subject-level intents have been added to DaLIA:
- Adverse Events
- Concomitant Medications
- Lab Results
- This also includes generic study/region/country/site modifiers for the above intents
LSAC 4.1 represents the first release on our new unified cloud architecture, and as such there are some small changes that bring common elements of previously-separate applications together.
- A revamped login screen with marketing-enabled configurations. Users will be able to see the LSAC latest news, product updates and events and access them directly from the login screen (performance may differ for SSO users).
- Application Admins will now have the ability to delete an app from App registration module and unpublish an app from the LSAC Marketplace using a User Interface.