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Saama Product Updates

Saama experts provide insight and analysis for clinical trial industry professionals at every level.

Sep

2022

LSAC 4.5.1 - Maintenance Release

September 23, 2022 / Saama,

Life Science Analytics Cloud 4.5.1 Updates

LSAC 4.5.1 Maintenance Bug Fixes

New features highlights and updates can be found in previous product updates.

What Issues Have Been Fixed Across Applications in LSAC 4.5.1: 

  • Planned Country is now visible in Operations Insights Dashboards
  • Oversight Scorecard Exports are working as intended
  • Executive Summary Dashboard: Study Tab – Query by Study Widget now works as intended
  • Subject Visit Dashboard – Filter dropdowns now display in chronological order
  • Subject Visit Dashboard – Protocol Version widget now displays in sequential order and properly enlarges to show the full list of protocol versions
  • Executive Summary >> Study details and Study milestones graphs no longer contain blank rows
  • Executive Summary – PDF exports now display all widgets and complete listings (Distribution by Phase/Program/Indication were missing from some PDF exports)
  • The Executive Summary – Study Tab user interface is no longer visually distorted
  • GPP Drilldowns for listing Highlighter and Scroll bar no longer display outside the GPP Tooltip
  • GPP swimlanes for Exposure and Datetime no longer split into 2 lines on tooltip
  • Multiple Unscheduled Visits in the Ops Insights Subject Visit Tracker are now ordered chronologically
  • Exec Summary – Overview – Enrollment Rate calculations are performed correctly
  • GPP 4.5: Data are properly aligned in Graphical Patient Profile Tooltip
  • The Smart Suggestions Window in Clinical Insights now appears for all LSAC accounts
  • The “more options” button now expands correctly in the Executive Summary – Study Specific Tab
  • The milestone tooltip appears properly when users hover over the “Days Ahead” related milestone in the Executive Summary Dashboard – Study Tab
  • The Subject Visit Dashboard: Subject Visit Tracker no longer displays a download completion of more than 100%
  • Executive Summary Dashboard: Study Tab – Enrollment by Arm/Cohort columns now match when listings are downloaded as .csv
  • Lab-Listing – Screen Failure subject details now display properly
  • Executive Summary- Study Tab: The key KPI widget now displays properly
  • Executive Summary Dashboard – Study Tab: The Gantt chart tooltip is now clearly visible
  • Corrected Summary Card Data for multiple Operations Insights Dashboards
  • Oncology data in Smart Clinical Explorer now displays correctly when the ‘Subject with Partial Response’ filter is applied
  • ESD: Overview tab – Study details table : Column freeze functionality
  • Vital Signs swim-lane trend lines in Graphical Patient Profiles now render correctly
  • Data are no longer mismatched for Study Life Cycle
  • The drilldown progression from “Clinical Insights” to the “Change from Baseline SOD” now works as follows: Clinical Insights>>SCE>>Solid Tumors>>Change from Baseline SOD

Aug

2022

Product Update - LSAC 4.5

August 29, 2022 / Saama Technologies,

Life Science Analytics Cloud 4.5 Release

LSAC 4.5 Expands Operational Dashboards, Improves Data Review, and Integrated AI/ML into Medical Workflows

New features to LSAC applications are available in the latest 4 series release. Highlights include RECIST data integrations in Smart Clinical Explorer (SCE), the ability to flag single data points for review, and Medical Monitoring workflows that begin with ML recommendations. Prefer a video? Watch the LSAC 4.5 updates here.

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 4.5: 

New! A new tab, Solid Tumors, has been added to SCE

  • The addition of the Solid Tumors tab in the SCE dashboard gives insights into various components of an oncology study. The Solid Tumors tab is divided into various components that allows users to assess certain metrics and fetch relevant details. These components are:
    • Solid Tumors – Infographics – These provide a quick summary or overview on certain statistics associated with oncology, for a study/arm.
    • Solid Tumors – Disease Response Assessment – This widget provides an insight into the response of every subject to the treatment that is measured over study days. The widget displays a separate chart for each cohort of the selected study. The charts can be expanded or collapsed for viewing flexibility.
    • Solid Tumors – Change from Baseline SOD – This widget displays changes in % change from baseline SOD. It focusses on every subject’s overall best response to derive the widget chart. Percentage change from Nadir SOD is also measured.
    • Solid Tumors – Tumor Identification and Results Listing – This tabular listing tracks the progress of every subject, across all cohorts of the selected study, through the clinical journey by evaluating the test results on every visit conducted and recording the changes seen in lesions with respect to the treatment. It also lists down new lesion discovered.
    • Solid Tumors – Best Overall Response – This widget charts out the best overall response for every subject across all cohorts of the selected study. It also records the best percentage from baseline and gives the current status of the subject in the study.
    • Solid Tumors – Disease Response and Clinical Classification Listing – This tabular listing tracks the treatment response on every tumor for every subject, across study days, and projects the best overall response to the treatment. The color codes have been updated to identify the type of treatment response obtained by the subject.
    • Solid Tumors – The units of measurement will be seen in a column in the tabular listing, Tumor Identification and Results, which is part of the Solid Tumors tab in the SCE dashboard.
    • Solid Tumors – The legend names as seen in all the widget charts displayed under the Solid Tumors tab in the SCE dashboard will be consistent across the widget charts. The legend key will be consistent and in the same sequence order in all the three charts, i) Disease Response Assessment, ii) Best Overall Response, and iii) % Change from Baseline SOD and this is defined as follows:
      • Complete Response
      • Partial Response
      • Stable Disease
      • Progressive Disease
      • Not Evaluable

The Solid Tumors components (Infographics & Widgets) can be selected to be part of the filter story that can be applied across all SCE domains.

Enhancement! Two enhancements on GPP – Support for Multiple Clinical Domains and Exposure widget

There have been two enhancements done on Graphical Patient Profile (GPP). These are:

  • The GPP UX has been modified to show multiple clinical domains, such as, Vital Signs, ECG and so on.
  • The Exposure widget has been enhanced to show separate charts for each medication taken by the subject.

Enhancement! The Lab Charts to not show Screen Failure count

The Lab charts in the following dashboards have been updated to show subjects that have passed the screening or those who have been enrolled. The chart does not show subjects who have screen failed. If the Enrollment disposition is not available for a subject, then the Randomization disposition will be considered.

  • Lab Spaghetti Plot – Absolute Value
  • Lab Spaghetti Plot – Baseline Deviation
  • SCE dashboard – Lab Spaghetti Chart – Absolute Value
  • SCE dashboard – Lab Spaghetti Chart – Baseline Deviation
  • Lab Listing
  • Hy’s Law Dashboard
  • DILI Lab Results Over Study Day
  • Graphical Patient Profile (GPP)
  • Cohort Analysis – Average Result Trend
  • Cohort Analysis – Subject Trend Against Baseline

Enhancement! Time Logic in CI Listings

  • If the entry of time is missing in the USDM or has not been collected in the EDC, then the table field in the listings should display as blank. The absence of a time entry for a record should be seen as no value or as a blank field. The absence of date for any record in the listings should be seen as a blank field. No default date such as 01-Jan-1970 will be seen in case there is no date present for the record in the EDC. The listings implementing this change are:
    • MH Listing
    • CM Listing
    • AE Listing
    • Lab Listing

Enhancement! SCE tabs are restricted on Therapeutic Area

The Solid Tumors tab in the SCE dashboard will show only studies that have Oncology as its

therapeutic area.

Enhancement! Viewing options in Lab Spaghetti Plot – Baseline & Absolute Value & Labs tab (SCE dashboard)

The legend key, as part of the charts in LSP – Absolute Value & Baseline Deviation, now carry the option to view:

  • All Subjects – By default, the LSP chart will be seen for all subjects. Disabling the toggle key Enable All Subject will show none of the subjects.
  • Selected Subjects – When all subjects are not displayed on the chart, the user can be selective and choose only those subjects of interest from the legend key, whose lab chart the

    user wants to see.
  • All Visits – By default, the toggle key Enable All Visits is disabled and none of the visits are highlighted or marked on the chart. Enabling this toggle will allow the user to see data for all the visits on the lab chart.
  • Selected Visits – When the toggle key Enable All Visits is disabled, the user can select certain visits from the legend key and these specific visits of interest will be highlighted or will be marked on the lab chart.

Enhancement! Units for Higher & Lower Reference Range in all Lab Charts

Units will be visible or displayed for all higher and lower reference range values in all of the lab

charts given below:

  • Lab Spaghetti Plot – Baseline Deviation
  • Lab Spaghetti Plot – Absolute Value
  • SCE – Lab Spaghetti Chart – Absolute Value
  • SCE – Lab Spaghetti Chart – Change from Baseline.

Enhancement! Death logic has been updated

The calculation of the count of deaths applied to the Death summary card in the SCE dashboard has been modified to take the count from the Death table instead of the Disposition table.

New! Addition of QS domain in CQS schema

Users will be able to see the Questionnaire (QS) domain in CQS Schema under Enter Architect Mode. This can be used for creating tabular listings.

Enhancement! Withdrawal Rate Logic

The values in the two table fields: Withdrawn and Withdrawal of Consent are clubbed together to calculate Withdrawn % and Withdrawal Rate. The dashboard that is using the improvised calculation is: Smart Clinical Explorer (SCE) dashboard

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 4.5: 

New! Executive Summary Dashboard – Portfolio

A new dashboard, namely, Executive Summary dashboard – Portfolio’ has been introduced in OI that facilitates visibility of overall performance of all studies that are part of the management portfolio.

It comprises of primarily two tabs:

  1. Overview tab
  2. Study tab.

The Overview tab of the Executive Summary dashboard is powered with three main sections that help the executives gain competent insights into portfolio performance and behavior. These sections are:

  • Portfolio Summary – Drives insights into study distribution under various clinical

    perspectives.
  • Portfolio Performance – Drives insights into study performance through clinical assessment

    governing study progress.
  • Study Details Table – Drives insights into study milestones achieved and other metadata.

The Study tab has been introduced in the Executive Summary dashboard – Portfolio that renders comprehensive insights into the progress of a specific study indicative through milestones achieved, KPIs, and so on.

New! Subject Visit dashboard – Study

A new dashboard, namely, Subject Visit dashboard – Study’ has been introduced in OI that drives insights into the progress of the selected study of interest, by giving an account of every subject visit and its compliance status. An overall analysis of visits is possible by understanding the distribution of visits over participating sites and over scheduled visits, based on the stated visit compliance norms and the current protocol version being implemented.

A handy tool, the Subject Visit Tracker, provides a detailed analysis into the visit journey of every subject, from screening till the last disposition event, to include visit compliance details, such as, Missed Visits, Out-of-window visits, and On-schedule visits. Unscheduled visits are also recorded in the Subject Visit Tracker.

Enhancement! New column in Oversight Scorecard (Site View)

A new column, namely, LPLV (Last Patient Last Visit) has been added to the site-based view of Oversight Scorecard. The new column can be seen in the tooltip that appears over site name.

Enhancement! Withdrawal Rate Logic

The values in the two table fields: Withdrawn and Withdrawal of Consent are clubbed together to calculate Withdrawn % and Withdrawal Rate. Dashboards that are using the improvised calculation are:

  • Portfolio Summary dashboard – Portfolio
  • Site Summary dashboard – Site
  • Site Cross Study Performance dashboard – Site
  • Site Performance dashboard – Study
  • Enrollment Dashboard – Study
  • Oversight Scorecard

Enhancement! Subject by Treatment Arm widget has been renamed. For ease of understanding and reading, the Subject by Treatment ARM widget has been renamed to

Subject by Treatment Arm.

Enhancement! Legend key enhancement in Subject Status Tracker widget. The legend key of the Subject Status Tracker widget in the Enrollment Dashboard – Study has been

enhanced to cover all visit details highlighted in the widget.

Enhancement! KPI Table in Site Performance – Study

The table showing the highest and lowest performing sites, based on the KPI selected, has been enhanced to show the column: Enrollment Count. A new instant search facility has also been added to the table to obtain quick results.

Deep Learning & Smart Suggestions

What’s New for DaLIA in LSAC 4.5: 

  • New! Suggestion – EOT & AE & SAE
  • The aim of this suggestion is to highlight the abnormalities in count of SAE & AE and early EOT. The

    new suggestion shows the count of EOT (End of Treatment) which are due to SAE (Serious Adverse

    Events) and AE (Adverse Events). The input parameters for the same are: Non-Serious AE Count and

    Serious AE Count

    New! Suggestion – Prediction of AE based on Lab Results & Demographics

    The aim of this suggestion is to show the prediction of AE on a new subject that has enrolled and

    with a confidence score to understand better. A common Adverse Event (AE) can be predicted on a

    collection of new subjects with more or less of them having the same lab results and demographics.

    The input parameters are lab results and demographic data.

    New! Suggestion – Prediction of early EOT based on AE, Demographics

    The aim of this suggestion is to show the prediction of early EOT with a confidence score for better

    understanding. The input parameters are AE results and demographic data.

    New! Suggestion – Correlation of early EOT with new lab data

    The aim of this suggestion is to show the correlation of early EOT with new lab data derived, such as,

    VS (Vital Signs), PE, and EG. The input parameters are Labs, VS, PE, EG.

    New! Navigation to Smart Suggestions Panel from SCE dashboard

    When the SCE dashboard is loaded or selected from Analytics, the Smart Suggestions slider window

    popup will spring up to alert the user on relevant suggestions. The user may choose to close the

    slider window panel by clicking on the Cross icon at the top right corner of the panel.

    The Smart Suggestions icon, however, will still be visible at the lower right corner of the SCE

    dashboard. The user may click on this icon at any time to view the Smart Suggestions. The Smart

    Suggestions icon also shows the count of unread smart suggestions.

    The user may choose to disable the toggle that is present on the slider window popup. In this case,

    the count of new suggestions will not be seen on the Smart Suggestions icon.

    New! Factors & tools influencing Smart Suggestions

    A small introduction to Smart Suggestions and how they are being implemented can be accessed

    through the slider window panel. The user can click the Disclaimer link to open a window that gives

    more insights into the tools and factors governing Smart Suggestions.

    New! Slider Window Panel for Smart Suggestions

    The Smart Suggestions panel is enabled by default. Hence, when the user lands on the SCE

    dashboard, the slider window panel pops open to displays new suggestions. The user may choose to:

    • Disable Smart Suggestions: When the user decides to disable seeing Smart Suggestions, the

    user would need to manually open the slider window panel by clicking on the Smart

    Suggestions icon and would then need to disable the toggle. On logging again into the SCE dashboard, the Smart Suggestions slider window panel will not pop open, but the Smart Suggestions icon will still be visible, giving the opportunity to enable or disable the panel for

    new suggestions.

    • Close Smart Suggestions: When the user closes the slider window panel, if Smart

    Suggestions is enabled, then the user will not see the popup again even if the user switches

    between tabs of the SCE dashboard.

    New! Combining AE intents with AND/OR/BUT/NOT operators

    Multiple AE intents can be combined to yield results on the count of sites/subjects for a

    study/country/region in month/year.

    New! Combining Lab Results intents with AND/OR/BUT/NOT operators

    Multiple intents on lab results can be combined to yield results on the count of subjects for a lab

    result for study/country/region/site.

Clinical Data Review (CDR)

New! Creating Tasks on LSAC Listing Reports

An administrative user can now configure the task template to enable task creation on listing reports. Tasks can be viewed and associated cells of the listing that are part of the task can be highlighted. Tasks created on listings can be viewed from the listing. These existing tasks can be accessed through the Collaboration dashboard and can be made available for view and certain edit action.

Clinical Data Hub

Saama’s Clinical Data Hub (CDH) provides a pipeline for submitting & visualizing patient and operational data.

What’s New for CDH in LSAC 4.5:

New Features

Multi-tenancy supported – LSAC CDH 4.0 is now a multi-tenancy application across all its modules.

New! OTB Functions

The following OTB functions have been added as part of LSAC CDH 4.0

  • CONCAT
  • TRIM
  • ROUND
  • REPLACE
  • PROPCASE
  • COMPRESS
  • DTYPES

Enhancement! Parallel execution with Master Job

A new USDM job can be initiated and run simultaneously with the Master Job.

New! eTMF Adapter Enablement

New eTMF adapter enabled in scale to load data in CDH.

New! Scalar Adapter Support on Multi-Tenant

SCALE framework is aligned with CDH multitenant architecture and ensures smooth data flow to CDH.

Enhancement! Vendor and Custom Functions Enhanced

File adapter has been enhanced to support multiple file formats. New set of custom functions are added to handle different file formats.

May

2022

Product Update - LSAC 4.4

May 29, 2022 / Saama Technologies,

Life Science Analytics Cloud 4.4 Release

LSAC 4.4 Expands Exploratory Clinical Capabilities, Improves Safety Reporting, and Adds New Data Source Adapters

New features to LSAC applications are available in the latest 4 series release. Highlights include an expansion to Smart Clinical Explorer (SCE), support for handling trials with multiple visit schedules and adapters for Veeva and Oracle systems to speed data onboarding. Prefer a video? Watch the LSAC 4.4 updates here.

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 4.4: 

Expansion to Smart Clinical Explorer

Customizable Tooltip in Graphical Patient Profiles (GPP)

Introducing new listings of Vital Signs, Medical History, Electrocardiogram and Exposure

Dashboards Automatically Load with Study Data

  • Subject Progression
  • Graphical Patient Profile
  • Lab Spaghetti Plot – Absolute Value
  • Lab Spaghetti Plot – Baseline Deviation
  • Adverse Event – Toxicity Profile
  • Adverse Event – Reporting Delay

Saving Prime Table Configurations:

Users with Admin access can save/reset the configuration changes regarding column freeze/unfreeze/hide/view/sort and row collapsed/expanded mode functionality.

Functionality is applicable to listings in Smart Clinical Explorer dashboard.

Introducing new listings of Vital Signs, Medical History, Electrocardiogram and Exposure 

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 4.4: 

Loading Dashboards by default:

  • Following dashboards will now load by default. The mandatory filters are marked with a red asterisk mark and take up the alphanumerically 1st active Study value for rendering dashboard.
    • Site Activation Dashboard- Study
    • Enrollment Dashboard- Study
    • Quality Measures Dashboard- Study
    • Safety Summary Dashboard – Study
    • Data Metrics dashboard – Study
    • Study Summary Dashboard

Saving Prime Table Configurations:

  • Users with Admin access can save/reset the configuration changes regarding column freeze/unfreeze/hide/view/sort and row collapsed/expanded mode functionality.
  • The functionality is applicable to following dashboards:
    • Portfolio Summary Dashboard
    • Site Summary Dashboard
    • Site Performance – Study Dashboard
    • Site Activation Dashboard
    • Enrollment Dashboard

Enhancement to Safety Summary Dashboard – Study

  • Cumulative Enrollment line chart is added to Month & Time tabs of AE/SAE trends widget.
  • The tabs of AE/SAE Trends widget are now enhanced with lazy loading functionality.

Enhancement to multiple OOTB & KPI Subject Visit Compliance Dashboard & Listings

  • New columns are added to Subject Visit – Listing & Latest – Subject Visit Listings to display details about baselines, protocol versions, arms etc.

    These listings are also enhanced with additional new local filters for more focused data analysis.

    Subject Count by Latest Scheduled Visit – Study and Subject Count by Latest Scheduled Visit – Study/Country/Site dashboards are enhanced with a single select Arm filter.

Deep Learning Intelligent Assistant (DaLIA)

What’s New for DaLIA in LSAC 4.4: 

  • DaLIA can now handle queries regarding multiple similar intents coupled with AND/OR/BUT/NOT for following Intent
    • Adverse Events
    • Concomitant Medication
  • DaLIA Audit Trail download functionality at account level is now available under the Audit Trail section for users with admin access. 
  • DaLIA can now respond to the additions in local filters captured through user typed DaLIA queries for Disposition Events.
  • Smart suggestions: Smart suggestions will be shown on Smart clinical explorer. These suggestions are generated based on ML algorithms. Three use cases are taken in this release
    • Combination of Adverse Events & End of Treatment
    • Combination of I/E criteria and enrollment
    • Correlation analysis for output variable [Early-EOT] to  AE/Demographics
  • Maintain read status for analyzed suggestions: Users will be able to differentiate between read suggestions and unread suggestions. 
  • Users can now enable/disable smart suggestions

Clinical Data Hub

Saama’s Clinical Data Hub (CDH) provides a pipeline for submitting & visualizing patient and operational data.

What’s New for CDH in LSAC 4.4: New Features

  • Operations File browser has been introduced.
  • Actigraph Connector has been introduced as an API-based source adapter.
  • Adapters have been created and integrated into the CDH application to connect to PPD CTMS source system.
  • Stream Page Report has been introduced.
  • Operations (vendor) data can be extracted from the ODL layer.
  • Operations (vendor) data can be extracted from the CDM layer.
  • Operations (vendor) data can be extracted from the USDM layer.
  • Custom KPI dependency – Job.
  • Basic functions such as UPPER case, LOWER case, SUBSTR and others should be supported at row level operations to make development easier.
  • Keep/Drop/re-name variables should be supported at row Operations, which will reduce the load by removing un-necessary variables to transport into column level.
  • There is Adaptive Clinical Adapter support for API-based EDC and CTMS source inputs.
  • Oracle Inform EDC Adapter is now supported.
  • The Veeva Adapter supported for API-based EDC and CTMS source inputs.
  • Smartsheet adapter is supported as a source adapter in Medical Review History to support Dynamic Line Listing in LSAC
  • RAVE study alias enhancement.
  • The Data Browser now supports file downloads that contain records based on filter criteria applied.
  • Drop Zone pull job supports files of more than 1000
  • System supports the use of top layer domain to lower layer while doing the mapping.
  • Hierarchy values now support special char such as ‘,’.
  • Users can now apply filtering criteria on empty datasets.

Enhancements

  • Metadata export file name edited for clarity.
  • A custom KPI layer is now supported in Operations Data Browser
  • SFTP-S3 connection switch
  • GSDM structure can be updated with default columns
  • Delimited text files now support different delimiters
  • Two PDL on the Data browser
  • DLL history table shall be accessible from Data browser
  • Patient Extract job -PDL/Pre-conf/Conf update
  • Notification template has been updated to capture account details

LSAC Platform

Cross Platform Changes Primarily for Administrators:

  • A new account details tab in User Management Settings allows Account Admin users to add/edit any account level attributes such as MFA Settings, IP Settings and so on, directly from the UI. This tab also facilitates in connecting users with user groups and with other related information.
  • Admin users will be able to search users with the help of a search bar provided in the Users tab in the User Management app. Entering a specific email address in the search bar will pull up a single record in the table.
  • LSAC User Account status can be changed to Active/Inactive by a super admin user. Whenever account status is changed, an email will be sent out to all the super admin users informing them about the change in the user’s account status.
  • The existing LSAC account admin role has been renamed to User Admin in the LSAC platform.
    • The permissions for this role remain as-is. User Admins will be able to perform CRUD operations on the three tabs (Users, User Management, and Personas).
  • When setting up a new password the ‘New Password’ box will assess user inputs and will display check marks for all password conditions if they are met (ie. capital letters, special characters)
    • The Save & Next/Submit button will be enabled only when the new password meets all the necessary requirements.
  • A loader/spinner will be seen when the user clicks on the Submit button to switch to another LSAC account. The spinner indicates that backend processing is fetching the requested data.
  • A new utility will support migration of LSAC Analytics NEST Databases from Data Centers (DC) to Amazon Web Services (AWS)
    • The primary inputs for this activity are the source customer account details and the target customer account details. Since this is a database-level activity, it is important to note the time it takes to restore the target tables as they would be locked during this migration.
    • A backup of the target NEST DB is made before carrying out this activity.

Apr

2022

Product Update - LSAC 4.3

April 15, 2022 / Saama Technologies,

Life Science Analytics Cloud 4.3 Release

LSAC 4.3 Improves Custom Reporting Capabilities in KPI Studio

New features to LSAC applications are available in the latest 4 series release. LSAC 4.3 delivers performance improvements and new features for Saama’s custom report and dashboard builder, KPI Studio. Highlights include the canvas mode, which allows users to change the order and appearance of charts and listings in their KPI Studio dashboards, as well as performance improvements, a presentation mode, and improved cross-tab filtering capabilities.

KPI Studio

Customizable reports and an intuitive dashboard builder in KPI Studio provide clinical and operations teams unparalleled ability to visualize their data.

What’s New for KPI Studio in LSAC 4.3: 

KPI Studio Dashboard Builder

  • Canvas Dashboards – design creative dashboards on a flexible free-form canvas. The canvas supports multiple types of content objects (reports, filters, interactive buttons, images, text, shapes, icons) along with custom coded widgets to incorporate any functionality directly onto the dashboard.
  • Blueprint Widgets – Collaborate on dashboard design securely within KPI Studio.
  • Quick Charts – Charts widgets, present within Blueprint, can be further configured to create charts directly onto the dashboard without going through the steps in KPI Studio report builder.
  • Enhancement Dashboard Access – access permissions can now be modified without entering the Edit mode
  • Object Menu – additional operations can be performed on dashboard objects while in Edit mode
  • Report Branching – add multiple charts to a dashboard without running multiple SQL scripts
  • Undo and Redo Dashboard Actions – buttons for undo/redo make it easy to correct mistakes
  • Dashboard Filter Options – if a filter is added to a static container, users can:
    • Auto-run filters to visualize changes without needing to hit apply
    • Automatically adjust the height of the filter widget
  • Full Screen Mode – Published dashboards can be seen in full screen mode for better visibility.
  • Associated Reports – Reports can be added as links (one link = one report) to dashboards and presentations without being displayed in full to offer further drill-down capabilities.
  • Report Column Sort – Report columns can be sorted in Ascending or Descending order in Draft or Published Dashboards
  • Action Events – Push and pull data (to and from enterprise apps), custom workflows, internal or external events can be triggered with an Action Buttons. These buttons can be added to existing reports and dashboards as well.
  • Image Manager Supports Multiple Formats – JPG’s, PNG’s, TIFF’s… choose your favorite
  • Improved Visibility for Canvas Widgets – The drag-and-drop process of placing a widget onto the dashboard provides better visibility of the placement of the widget on the canvas.
  • Horizontal Filter Widget – a fresh addition to dashboards and presentations. This can only be added in a canvas layout.
  • Improved Performance – dashboard loading times have been considerably reduced with this release.

 

KPI Studio Report Builder

  • Sparkline Array Analytic – column data can be transformed into an array of aggregated values and yield a continuous sparkline to better capture the behavior of the metric over a period of time.
  • Action Button – create an action button that is linked to a URL. The column in which the button is created can fetch the returned data from the URL.
  • Edit Charts in Dashboard Design – Charts can be edited directly in dashboard design mode.
  • Image Link Formatter – display images in reports, instead of image URLs. Great for presentations!
  • Totals and Sub Totals Formatting Options – The aggregated totals, such as section totals, sub totals, grand totals, that are computed to provide the user with a higher understanding of data in a more detailed report, can be styled in color, font type, font size, alignment and so on, to draw immediate attention. The position of the subtotals, totals can be displayed at the start or end of the report table.
  • Column Header Formatting – Individual column headers, in a report, can be styled to change the background, fonts, alignment and formatting of the text through multiple options.
  • Basic and Advanced Sub Queries – The Basic and Advanced sub query function has been enhanced to accommodate joins on fields that are not part of the final report but are part of the same view that the report is based upon.
  • Top/Bottom N Rank – The Top/Bottom N Rank function returns the top N or the bottom N values or ranks of the selected field in a report. The options ‘Non-threshold values’ and ‘Display Type’ provide a better understanding of the function.
  • Percentage of Segment Function – A new advanced function, Percentage of Segment Function, has been added that calculates the percentage of a subtotal for a dimension segment on selected metric in report tables.
  • Days between Date with Offset Function – A new advanced function, Days between Date with Offset Function, has been added that returns the number of days between two selected date fields in report tables.
  • Growth Truncate – Growth Truncate, has been added to calculate and display the truncated growth between two metric fields as a percentage.
  • Accumulative Percentage Against Column –  Accumulative Percentage Against Column, has been added to calculate and display the percentage of running total of field against the running total of other fields.
  • Percentage Against Accumulative Column – Percentage Against Accumulative Column, has been added to calculate and display the percentage of a selected field against running totals of other fields.
  • Difference Truncate – A new advanced function, Difference Truncate, has been added to calculate and display the truncated difference of two metric fields.

 

KPI Studio Filters

  • Dashboard Filter Reset Control – Application of this property will reset the entire dashboard to its original state irrespective of linked/unlinked filters. It will reset all filters and other dashboard interactions, including drill functions applied by the user.
  • Dashboard Filter Configuration – Dynamic filter values will automatically select the first filter value of a dimension field if the default filter value is not available
  • Improved Cached Filters – Two options have been added to provide more flexibility in viewing data in Cached filters. These are:
    • Ignore Report Filters when loading Cached values
    • Restrict SQL context to Filter Columns only
  • Improved Dashboard Properties Pane – The addition of the Left Filters toggle key to the Dashboard Properties pane allows the user to show/hide additional filter options, such as Hide Reset link, Auto Run filter, and so on, on the left side of the screen for easy accessibility and application.
  • Global Filters – can be fixed in place and are always visible as the user scrolls through dashboard charts.

 

KPI Studio Charts

  • Chart Gridlines – Chart gridlines can be applied, through the Background tab, from a varied set of options, such as Numeric Axes/Horizontal Axis/ Vertical Axis/All Axes/None.
  • Accumulation Function – The accumulation percentage or the running total value of a total line in a chart, can be seen with the help of a secondary axis and thus draw out a Pareto-like analysis on the chart.
  • Category Trimming – Trimming values on bar and column charts can be applied when too many values in a selected dimension field make it difficult to read the chart and using this toggle key would help to trim or cut out values from the chart.
  • Logarithmic Option for Numeric Axes – Using the Logarithmic option resolves a visualization issue that occurs when a few data points are much larger than most of the data points in a dataset and thus prevents the data display from being skewed.
  • Formatting options for Multi Pie Charts – Multi Pie charts can be sorted through a varied set of sorting options and the labels can be styled through various formatting options such as font formatting and so on.
  • Axes in smaller charts – Axes titles can be chosen to be displayed for smaller charts through the Show/Hide Axis Title toggle present for both the horizontal and vertical axis.
  • Variance function – Simple Percentage – The variance function, Simple Percentage, displays the difference between two fields, in a chart or table. The variance can be displayed as a calculated value or as a percentage difference.
  • More functions on Charts – More functions, such as Accumulation, Average, and Trend have been enabled on non-auto Area, Bar, and Column Charts.
  • Waterfall Chart – Waterfall charts have been enhanced to support dynamic inputs on Start column, to configure column titles for both the start and end columns and to also support custom colors.

 

KPI Studio -Dashboards & Reports

  • Hide Report Name – By default, the report name will be hidden on both static and canvas dashboards. The toggle key Hide Report Name allows the user to either show or hide the report name. If the report name is shown, then it will be placed directly above the report and cannot be formatted.
  • Keyboard shortcut key – A keyboard shortcut, namely, Crtl+A, has been supported that allows the user to select all widgets on a draft canvas in one go.

 

KPI Studio – Export

  • PDF Export – A PDF export on a dashboard is made possible through the Export PDF option and this has removed the need to specify an external base URL. A varied set of options can be explored for a more refined PDF output.

 

KPI Studio Views

  • View Builder Access – The View Builder has been enhanced with a new navigation menu, providing streamlined data preparation experience for field setting properties, performance, security, and automation configuration.
  • Restricted access to View columns – This features allows specific columns to be shown/hidden to specific users.

 

KPI Studio Presentations

  • Presentation Module – KPI Studio Present is a fully integrated presentation module designed for data-led communications. This module contains functionality similar to the dashboard canvas. A presentation slide supports multiple types of content, images, text, shapes, code widgets, filters, action buttons and so on.
  • Exit button – An exit button has been added to exit from KPI Present full screen mode.

 

KPI Studio – Miscellaneous

  • Code Widgets – This feature enables the user to add code widgets, like Associated Reports, Videos into presentations and into canvas dashboards.

Mar

2022

Product Update - LSAC 4.2

March 14, 2022 / Saama Technologies,

Life Science Analytics Cloud 4.2 Release

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.

Jan

2022

Product Release - Clinical Data Hub 3.0

January 24, 2022 / Saama Technologies,

Clinical Data Hub (CDH) 3.0 Release

Clinical Data Hub 3.0 

Clinical Data Hub (CDH) 3.0 is a production version release of the data pipeline of patient and operations data. New features for this release center around custom KPI processing and support for custom KPI transformations.

CDH 3.0 also brings updates to Global Setup and improvements to Data Mapping processes.

What’s New for CDH 3.0:

New Features

  • Enable custom KPI processing and support for custom KPI transformations
  • Added Data Browser capability for Operations Data.
  • Enabled Biostatistics data pulls via Rave API for the dataset where coding is performed.

Improvements to Global Setup

  • Cross schema mapping enabled for the CDM and USDM layer.
  • Enable Study wise job submission for CDM and USDM layer.
  • Enable Import/export the custom function on the Global admin-Transformation.

Improvements to Data Ingestion and Cleaning

  • Support of Excel, Parquet, ORC and Avro file format processing.
  • Support Metadata changes for the operations pipeline data flow.

CDH Pipeline

Use Smart Applications (SAM, SDQ, and SPACE) to quickly transform patient and operational data for use in LSAC Packaged Apps (Operations Insights, Clinical Insights, RBQM & KPI Studio)

Oct

2021

Product Update - LSAC 4.1

October 17, 2021 / Saama Technologies,

Life Science Analytics Cloud 4.1 Release

LSAC 4.1 Enhances Operations & Clinical Dashboards and Enhances DaLIA Functionality

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.

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 4.1: 

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:
    • Active
    • Enrollment Open
    • Active – No Longer Recruiting

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 4.1: 

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
    • Screened
  • 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

Platform Changes

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.

These Include:

  • 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.

Aug

2021

Product Release - Clinical Data Hub 2.0

August 30, 2021 / Saama Technologies,

Clinical Data Hub (CDH) 2.0 Release

Clinical Data Hub 2.0 

Clinical Data Hub (CDH) 2.0 is a production version release of the data pipeline of patient and operations data. This release delivers a self-serve UX for patient and operations data ingestion, quality checks, transformation and extraction.

CDH and the global, study, and metadata management modules can be accessed in LSAC 4.0 for select administrative users.

What’s New for CDH 2.0:

Global Setup and Security Control:

  • Self Serve UX for configuration of source system, Study onboarding and Data Quality Rule setup
  • Self Serve UX for reference data upload
  • Study level access control

Data Ingestion and Cleaning:

  • Out-of-box adapters for Medidata Rave, IBM CD and Medrio
  • Out-of-box adapters for delimited text file, sas7bdat and xpt format data ingestion
  • Ability to process blinded and real data in patient pipeline
  • Data Quality Dashboard
  • Approval workflow for metadata and maps

Transformation and Traceability:

  • Transformation UX for Patient data transformation
  • Approval workflow for transformation rules (map)
  • Ability to perform transformation on operation data to USDM model
  • Traceability report

Data provision and Notification:

  • Data browser or view of Patient data at each layer
  • API to extract patient data from any layers
  • Self Serve UX for Job management
  • Notification on job failure, metadata update, approval request

CDH Pipeline

Use Smart Applications (SAM, SDQ, and SPACE) to quickly transform patient and operational data for use in LSAC Packaged Apps (Operations Insights, Clinical Insights, RBQM & KPI Studio)

Jul

2021

Product Update - LSAC 3.7

July 31, 2021 / Saama Technologies,

Life Science Analytics Cloud 3.7 Release

LSAC 3.7 Improves Ops & Clinical Dashboards, Expands USDM and Enhances UX

The largest expansion to LSAC in some months, LSAC 3.7 delivers major improvements to popular Operational Dashboards, expands USDM for oncology datasets, and brings incremental improvements to UX and a single Clinical Insights dashboard. Want updates in video form? Watch the 3.7 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 3.7: 

Site Summary Dashboard: Addition of new KPI: Site Start-up Time

  • Understand the time taken to get a site activated
  • View planned vs. actual activation times for sites; compare site activation to mean times studies and countries.

Enrollment Dashboard – Study: Widget Enrollment Funnel

New subject disposition events added:

  • Treatment Initiated
  • Treatment not Initiated
  • Discontinued before Treatment
  • Discontinued after Treatment
  • Follow up Agreed
  • Follow up not agreed
  • Withdrawal of consent
  • Screened*

Quality Measures Dashboard – Study Enhancement

  • Ability to filter PDs by ‘Major’ and/or ‘Minor’ categories at the study level
  • Ability to get insights into protocol deviations against subject enrollment numbers and site activations count

Site Activation Dashboard – Study Enhancement

Widget – Site Activation Over Time

  • Users will be able to look at site activation & enrollment metrics together
  • Determine if enrollment is increasing/decreasing because of newly activated sites activated OR if older sites are contributing to enrollment

Widget – Study Site Progress Status: View by Startup Funnel (New)

  • Addition of study startup milestones

Portfolio Summary Dashboard 

  • Design Improvements

Site – Cross Study Performance

  • Site Specific Performance – Site dashboard renamed to Site – Cross Study Performance
  • New look and feel of entire dashboard aligned to other site dashboards
  • Ability to view site-specific performance across studies conducted in the site of interest under user’s portfolio for various KPI’s

User Experience with respect to Data Unavailability

Users will be able to see all active site names (by default) depending on study and country filters

Created bucket for Site status (USDM enhancement – Site table); currently implemented in Site Summary Dashboard and Cross Study Performance Dashboard

  • Active: All active sites
  • Closed: Closed/Archived/Terminated Sites
  • Inactive: All other status of sites like on-hold, proposed, cancelled, candidate, initiating, not participating, etc.

USDM Model expansion

  • Additional data points to ingest more information related to AE and Oncology Tumor Assessments (RECIST data)
  • Addition of ‘Visit’ column in TVA table in USDM as primary key.
  • Addition of table : CohortMilestone | CohortPlannedRecruitment |Death

 

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 3.7: 

Lab Spaghetti-Absolute Value Dashboard: Enhancements

  • Ability to select multiple lab tests for multiple subjects.
  • Ability to choose the X axis to be as Study Days or Visit Schedule
  • Ability to zoom the specific chart area of interest across the Y and X axis.
  • View baseline visits represented as hollow icons to easily distinguish them from all other visits.
  • Performance Improvement – Dashboard widgets will load asynchronously to provide you faster insights!

Jul

2021

Product Update - LSAC 3.6

July 2, 2021 / Saama Technologies,

Life Science Analytics Cloud 3.6 Release

LSAC 3.6 Improves Task Management Across all LSAC Applications

Fresh on the heels of the impactful LSAC 3.5 release, LSAC 3.6 delivers improvements that make task management in Operations Insights, Clinical Insights, and RBQM more configurable at an organizational level.

Task Management

Track, prioritize, and delegate tasks across LSAC applications (Operations Insights, Clinical Insights, KPI Studio, and RBQM) in LSAC itself with the task management module.

What’s New for Task Management in LSAC 3.6: 

LSAC tasks will now be configurable through a template where your account administrator will have the flexibility to request additional fields in the Task Details section. These fields will appear when an LSAC user creates any task in a specific analytics context.
There will be three types of Task attributes:
  • Core Attributes: Mandatory fields like task type, description, status, assignee, etc.
  • Extended Attributes: Custom standalone fields to be added to the task panel, it will support text or date format inputs.
  • Clinical Attributes: Fields from the database such as Study, Country, Site, Subject, Form etc.

Jun

2021

Product Update - LSAC 3.5

June 13, 2021 / Saama Technologies,

Life Science Analytics Cloud 3.5 Release

LSAC 3.5 Improves Patient Safety Analytics & High-Priority Operational Reports

We are excited to announce the next release of Saama’s Life Science Analytics Cloud. We’ll detail new features and enhancements to Operations Insights, Clinical Insights, and DaLIA.

Clinical Insights

Analytics that complement our popular Graphical Patient Profiles and improvements to GPP itself make LSAC 3.5 one of the most impactful Saama releases to date for medical and safety monitors.

What’s New for Clinical Insights in LSAC 3.5: 

  • The Subject Event Log dashboard captures key observations – like dosing, AE details and CMs – recorded through clinical visits for a specific subject over time.
  • The Subject Progression dashboard charts the sequence of events such as disposition changes, dosing information, any AE/CM events in a browsable ‘patient story’ format
    • Subject Progression is very useful for deciding which Graphical Patient Profile to Investigate
  • The AE Reporting Delay dashboard captures discrepancies and delay between the occurrence and reporting of adverse event for multiple subjects at a specific active site.
  • The Lab Spaghetti Plot – Absolute Value dashboard charts lab values for lab tests for multiple subjects across sites, and visits. This allows medical and safety monitors to filter out outliers and noise and hone in on meaningful safety signals.
  • The Lab Spaghetti Plot – Baseline Deviation dashboard – examines the deviation of patient lab test results from the baseline (and is visually and functionally very similar to the Absolute Value Spaghetti Plot).
  • The Adverse Events – Toxicity Profile dashboard provides counts of every unique adverse event across treatment arms,
  • The GPP dashboard has greatly improved performance (swim lanes individually as opposed to all at once) and has been enhanced to give additional details on
    • Demographic summary
    • Subject’s exposure to dosing
    • Lab results
    • Sequence of AE’s and CM’s over a period of time

Operations Insights 

With this release, we have focused on specific, high-priority analytics which improve your ability to get to the insights you need quickly and with minimum fuss

What’s New for Operations Insights in LSAC 3.5:

  • An improved Safety Summary Dashboard, so you can directly perform site level analysis of adverse event trends
  • The Site Activation Dashboard now tracks milestone cycle times across countries for startup and study conduct
  • A new report which shows you the time of the latest data refresh from various source systems
  • A significant visual makeover for the Portfolio Summary Dashboard, which now
    • Reports treatment arm and cohort level insights
    • Groups studies by various categories such as TA or Study phase
  • The Site Summary dashboard now reports site performance against the country average, and also sports improvements to view configurability and ease of use (you can drag and drop column headers to more quickly compare results among different sites).
  • Finally, 8 dashboards now have the Export to PDF feature enabled (snapshotting) so that you can directly port graphics into presentations.

Smart Search Powered by DaLIA

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 she doesn’t want to be outmatched by her cousin Smart Data Quality), so we encourage you to ask her some trial-related questions to see what she’s made of.

What’s New for DaLIA in LSAC 3.5:

Dalia is trained on 15 new and more precise timeframe-based intents, including:

  • Site activation, subject disposition, visits, lab results, site issue management, and site milestones

Feb

2021

Product Update - LSAC 3.4

February 25, 2021 / Sean Svejda,

Life Science Analytics Cloud 3.4 Release

LSAC 3.4 Brings Improvements to Operational Dashboards and Risk Detection

We are excited to announce the next release of Saama’s Life Science Analytics Cloud. We’ll detail new features and enhancements to Operations Insights, DaLIA, and RACT.

Operations Insights

The Operations Insights application provides timely, targeted analytics to enable executives, study managers, and CRAs to monitor and optimize key operational metrics across a portfolio of clinical studies for functional areas such as enrollment, subject compliance, and site productivity. 

What’s New for Operations Insights in LSAC 3.4:

Enhanced Site Activation Dashboard:

  • Ability to Track Activation Progress of individual Study Site(s)
  • Ability to display Mean Cycle times for study start-up milestones Cross-Site 

Enhanced Enrollment Dashboard:

  • Ability to track Screen Failure reasons
  • Disabled Study completion by Visit Widget from the dashboard
  • Ability to track Enrollment Progress of each Study Sites

Enhanced Quality Measures  Dashboard:

  • Ability to track Protocol Deviations reported by each Study Sites for direct exposure to each study site performance w.r.t to protocol deviation.
  • Enable Count of Sites for each Country in existing Site Issue widget

Enhanced Data Metrics Dashboard:

  • Ability to track Data Quality matrix for each Study Sites

Freeze Column and Header in Listing reports for improved user experience when scrolling to the right.

Smart Search Powered by DaLIA

LSAC Smart Search is powered by Saama’s proprietary Deep Learning Intelligent Assistant (DaLIA). DaLIA is trained to understand and answer questions, in English, in the clinical development domain.

What’s New for DaLIA in LSAC 3.4:

Dalia is trained on the following intents 

  • Concomitant Medication 
  • Protocol Deviation 
  • AE Frequency (% of subjects) by AE term, relatedness, and severity.

Longitudinal Search query (time-based search option)

  • Count of AE/SAE reported in the last 30 days?
  • Count/ Rate of Protocol Deviation in last 15 days or between the particular time period/date range

DaLIA Smart search bar enhanced to include:

  • Studyid / Study name enabled in Auto suggestions for study entity questions
  • Intuitive sequencing of Auto-fill suggestions 
  • Entity Auto-suggestion considers MSF (Master study filter)

RACT (Risk Assessment and Categorization Tool) Enhancements

In case you need a refresher, LSAC’s RACT (introduced in the 3.2 release) allows you to easily facilitate risk planning, assessment, and mitigation in a collaborative manner.

What’s New for RBQM in LSAC 3.4: 

  • Enhanced Audit Trail functionality to include timestamp and action performed.
  • Ability to Save and continue later with RACT assessment and Template configuration 
  • Ability to view previous versioning of RACT template to allow the user to revisit and compare changes to templates

Bug Fixes

  • Harmonize business logic for Protocol Deviation Count across dashboards, Dalia Output, and List Report
  • COM-2695: After selecting the last AE on the bar, details are not visible while hovering over it. Need to show AE details inside the KPI.
  • CS-5531: Data Metrics Dashboard – on the Data Point Collection Bar chart ‘Data Point Completion %’ total count is more than 100

Saama can put you on the fast track to clinical trial process innovation.