New features to LSAC applications are available in the latest 4 series release. Highlights include country level metrics in the Executive Summary Dashboard (Operations Insights), improved configurability in Graphical Patient Profiles (Clinical Insights), and improved ML recommendations in Smart Clinical Explorer (Clinical Insights). Prefer a video? Watch the LSAC 4.6 updates here.
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 4.6:
Smart Clinical Explorer (SCE):
- Tool-tip configurability has improved across Smart Clinical Explorer tabs (particularly in the ‘Patient Story’ widget in the demographics tab)
- Tab retention: Smart clinical explorer tabs and filters will be retained if users navigate away from SCE and back again. This is very useful for switching between Graphical Patient Profiles and Smart Clinical Explorer.
- In the ‘Solid Tumors’ Tab in Smart Clinical Explorer, the Change from baseline Size of Diameters (SoD) chart now includes a drill-through table so reviewers can evaluate changes in tumor size without leaving the ‘Solid Tumors’ Tab
Graphical Patient Profiles (GPP):
- A clearer user interface with nested dropdown arrows makes it easier to evaluate which lab test/ECG swim-lane is currently active.
- A configurable tool-tip for the ConMed/AE section allows a wider range of severities to be represented when hovering over individual data points.
- Cause and date of death boxes now appear in patient summary cards at the top of GPP.
Subject Progression Dashboard:
- Last dosage date now appears as a component in patient swim lanes
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 4.6:
Executive Summary Dashboard:
- A new ‘Country’ Tab in the Executive Summary Dashboard contains the same widgets as the ‘Summary’ and ‘Study’ Tabs. This new tab is ideal for regional or country managers, and enables quick filtering of data for a single country. The table at the bottom of the SCE tab offers a quick drilldown into site level information for each site from the selected country.
- PDF alignment issues have been resolved when exporting the executive summary dashboard tabs in PDF form.
- Supplemental tables in Enrollment Dashboard give more context to enrollment graphics. One new and one refined table are visible at the top of the dashboard.
Quality Measures Dashboard:
- A filterable ‘Protocol Deviations – Listing’ table at the bottom of the Quality Measures Dashboard provides deeper insights into protocol deviations compared to the graphical data. This table can be easily filtered by country, study, site, visit number, etc. and generally has the same functionalities as other Operations Insights listings. The inclusion of this table should save users the hassle of switching between graphs and tables.
Site Activation Dashboard:
- Refined summary cards at the top of the dashboard.
- A new country activation details widget automatically filters the site activation listing at the bottom of the dashboard. This should reduce the time users spend filtering and re-filtering to compare different level data.
- The ‘Study Site Progress Status’ widget has been updated with a table, which users can quickly toggle on. Users can see the completed, planned, or projected dates of site milestones.
- The milestone cycle time widget has received a time-scale toggle for days, weeks, and months
- Neat packaging of all dashboard features as a PDF export.
Deep Learning & Smart Suggestions
What’s New in LSAC 4.6:
- New AI suggestions include:
- Correlation of Early subject End of Treatment, Medical Histories, ConMeds and AEs.
- Counts of subjects with certain AE-CM-MH combinations.
- Counts of subjects with certain Serious AE-CM combinations.
- Icons for confidence score display the predicted accuracy of an AI/ML prediction.
- Easily provide your feedback with a quick thumbs up/down or enter a longer text response or question.
- The ‘Apply as story’ button should make it clear that you can click the suggestion to load Smart Clinical explorer with the suggested filters.