Product Update - 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.