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Product Update

Product Update - LSAC 4.2

LSAC 4.2 Brings a Powerful New Means of Clinical Data Exploration to the LSAC Platform

New features to LSAC applications are available in the latest 4 series release. LSAC 4.2 delivers Smart Clinical Explorer, a powerful means of visually exploring patient data in Clinical Insights, useful new Operations Insights widgets, and powerful logical operators in DaLIA. Prefer updates in video form? Watch the 4.2 updates here.

Operations Insights

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 4.2: 

Enhanced Site Activation Dashboard – Study

  • Addition of new widget ‘Site Activation Status’ view by Study and Country
  • The ‘Site Enrollment Status’ widget is moved to the Enrollment dashboard.
  • ‘Site Activation and Enrollment Over Time’ widget is enhanced with Month & Cumulative tabs for better user experience.
  • ‘Site Activation by Country’ widget is replaced with ‘Site Activation – Listing’
    • functionality to download as CSV
    • Freeze/Unfreeze/Multi-Sort columns.
    • Related analytics is removed.
  • ‘Milestone Cycle time’ widget is enhanced with a cohort tab which includes cohort level milestones.
    • Users can select a milestone to view cycle time at the site/country/cohort level.

 

Enhanced Enrollment Dashboard – Study

  • ‘Site Enrollment Status’ widget from Site Activation Dashboard – Study is

    added here.
  • ‘Enrollment Funnel’ widget is enhanced with view by- study, site and

    country level tabs.

    • The data is visible in both graphical as well as tabular format.
    • Users will be able to select Site and country of interest.
    • Imp: dropdown is single select in graphical and multi-select in tabular form.
    • Users will be able to drill down from Study > Country > Site in Tabular view.
  • ‘Subject Withdrawal by Reasons’ is now available as an independent widget at Study, Country & Site of interest.
  • New widget ‘Subject by Treatment Arm’ is added & shows monthly

    actual count of Randomized/Enrolled subjects at Study and Site levels

    • Users will be able to see the monthly data for a particular site (Single select) from study start date to study completion or current date in case of ongoing studies.
  • ‘Total Enrollment’ widget is replaced with the new ‘Subject Status Tracker’ widget.
    • Provide details around Subject, Cohort, current subject status, consent date, Randomization and subject visits

 

Addition of Single Select Cohort Filter

  • Single select Cohort/Arm Local Filter have been added to multiple dashboards in the study focus area:
    • Enrollment Dashboard
    • Site Activation Dashboard
    • Safety Summary Dashboard
    • Quality Measures Dashboard
    • Data Metrics Dashboard

 

Addition of USDM Data Refresh Date & Time to multiple dashboards

  • USDM Data Refresh Date & Time in UTC format with colored indicators have been added to multiple dashboards (Portfolio Summary Dashboard, Site Summary Dashboard, Study Summary, Site Activation Dashboard – Study, Enrollment Dashboard – Study, Site Performance – Study, Site – Cross Study Performance, Quality Measures Dashboard- Study, Safety Summary Dashboard – Study, Data Metrics dashboard – Study)

Clinical Insights

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 4.2: 

Introducing the Smart Clinical Explorer (SCE):

  • New multi functional exploration dashboard – starting point for medical monitor

    analysis of a study
  • Adverse Events, Demographics, Disposition, Labs and Concomitant Medication

    domain data all available in one place for a study
  • “Filter story” feature stores selected filters across domains. This filter story can also

    be saved for future use.
  • Interactive Site, country, cohort filters which are linked with each other.
  • Graphical Patient Profile view shows relevant subject IDs, and can be used as subject filters; Subject IDs redirect to the GPP for the selected subject.
  • Clickable summary cards for Demographics, Adverse Events and Concomitant Medication tabs which work as interactive filters as well as infographic summaries
  • Demographics Tab:
    • Widgets for Age, Gender, Race and Disposition information
    • Disposition and Demographics Listing is added
  • Adverse event Tab:
    • Time series chart showing subjects count for AEs over time
    • Adverse Event graph shows the count of subjects for individual Adverse Events in tabular as well as chart view.
    • Adverse Event Listing also shows the CTCAE grading information.
  • Labs Tab:
    • New Lab test filter and enhanced Lab Spaghetti Plot
    • Both absolute value and baseline deviation chart is shown in the same

      widget with a subtab.
    • There is no toggle for study days and visits. The x axis shows only study days. The visits are shown as clickable legends.
    • Lab spaghetti plots can now be filtered for subjects with abnormal values.
    • Lab summary table is introduced to show the summarized information for each visit for a lab test
    • Lab listing is added to show the detailed lab information
  • Concomitant Medication Tab:
    • Concomitant Medication graph is the new widget that shows the count of subjects for individual Concomitant Medication in tabular as well as chart view.
    • Introduced Concomitant Medication Listing

 

Enhanced Lab Spaghetti Dashboard:

  • The lab spaghetti plot is enhanced for both absolute value and baseline deviation chart.
  • There is no toggle for study days and visits. The x axis shows only study days. The visits are shown as clickable legends.

 

Addition of USDM Data Refresh Date & Time to multiple dashboards in Clinical Insights

  • USDM Data Refresh Date & Time in UTC format with colored indicators have been added to multiple dashboards, including Smart Clinical Explorer, Subject Progression, Graphical Patient Profiles, Lab Spaghetti Plot, and Adverse Event – Toxicity Profile

 

Clinical Data Review and Collaboration workflow:

  • Task Enhancements across all dashboards:
    • The task pane will be overlaid on the dashboard and users will be able to create tasks without the dashboard getting resized.
    • Tasks will be created with unique task ID and Auto generated task title based on the context the task is created
    • Introducing a mini task console which will remember all the selected attributes while creating the first task on the dashboard during a logged in session and minimizing the time taken to create any subsequent task.
    • Any task created will remember the filter context and will launch the same

      context when it is revisited
    • Now each task created on Operational insight, clinical insight or RBQM will capture a screenshot of the task to provide you the information of point in time data, you will have the option to keep the screenshot, remove it or recapture it.
  • Additional Task functionality on Smart Clinical Explorer (SCE):
    • In SCE, users can create tasks by right clicking on any data point
    • Task list will be available with each widget to show what tasks are created with respect to the widget and study selected.

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 4.2:

DaLIA can now handle queries regarding multiple similar intents coupled with AND/OR/BUT/NOT for following Intents

  • Protocol Deviations at Study/Country/Site.
  • Site Issues at Study/Country/Site.
  • Query Resolution at Study/Country/Site.
  • Disposition Events (Enrolled & Screened) at Study/Country/Site.

DaLIA suggestions: Introducing DaLIA suggestions in the Smart Clinical Explorer built on the newly developed AI/ML framework for Clinical Insights. As part of the 1st release, we are introducing one use case – ML model generated suggestions based on Age, Seriousness of AE and Adverse Event.

Platform Changes

LSAC 4.2 represents the second release on our new cloud architecture. Several changes have been implemented to develop LSAC as a unified platform.

These Include:

  • Flagging users who use Single Sign On (SSO) in User Management:
    • Account administrators can mark users as SSO (Single Sign-on): <On or Off> directly from the User Management UI, or manage bulk user permission updates via excel upload.
  • Remember Me functionality in LSAC Login page:
    • LSAC can remember the login id at the time of login/ session expiry if the checkbox is selected during login
  • For regulatory compliance, every LSAC user will be informed of Saama’s cookie policy; a popup box will prompt the user to read and accept the policy at the time of login.
  • An extra security mechanism has been introduced at the time of LSAC login. Users must input a One-Time Password (OTP), distinct from their username and password to enter the LSAC application.
    • Every user will receive their OTP in their email when they attempt to log in
    • When an account opts for turning on MFA, every existing user will be prompted via email to complete the OTP activation process in order to login in LSAC.
    • The MFA (OTP) mechanism is not applicable for SSO users
  • Streamlined User Activation flow:
    • The user experience for new users activating their accounts requires fewer steps for faster activation and onboarding
    • A consolidated email workflow for “Update your LSAC Account” has been created for any updates made to an existing user account
    • The LSAC Collaboration dashboard (known informally as the task management dashboard) is enhanced with improved task widgets and filters highlighting priority, overdue and favorite tasks
    • Furthermore, the LSAC Collaboration dashboard now serves as an “inbox” for users to manage their workload across LSAC apps, and each task launches the corresponding application with the correct contextual details users require to complete their task.

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