Life Science Analytics Cloud (LSAC) is the leading AI-powered clinical analytics platform from Saama that seamlessly integrates clinical trial data, delivering more actionable insights for faster decision making. Saama’s proven suite of cloud-based applications in LSAC offer powerful data aggregation, monitoring, analytics, and collaboration capabilities, so sponsors and CROs can optimize study planning, enrollment, compliance, productivity, and oversight.

This document contains important information on new features and updates for LSAC v3.1.

This section gives a list of new features and/or updates for each module worked upon or improvised.

COM-140, COM-141, COM-142, COM-143: Financial Summary Dashboard that provides a                             summary of the financial performance of the Clinical trial over time

The Financial Summary Dashboard has been added to provide a summary of the financial performance of the trial over time. It gives a summary view around Budget for the study, Actual Expenditure till date and Forecasted expenditure for the future. For a Clinical Study, Spend Progress can be viewed over monthly, quarterly and yearly basis; and can be further analyzed over a desired period of time, for specific countries and sites involved in the study. Financial summary dashboard also enables a view on cost drivers across categories (fixed site costs and per subject variable costs) and also offers a granular drill down view around different events or activities (sub-category) showing the budget, actual spend, difference between actual and budgeted spend, and forecasted expenditure.

COM- 145, COM-147 and COM-148: Spend Analysis Dashboard to analyze spend progress over time as well as financial performance at a site-level for a given duration

The Spend Analysis Dashboard has been added to show the trend in expenditure for different categories like Site Standard Cost and Patient Cost. ‘Spend by site’ view enables spend comparison across selected sites showing budget and actual spend incurred on that site; with actual expenditure divided across Site Standard Cost and Patient Cost.

COM- 130, COM-131: Spend Details Dashboard to list all the expenses incurred on site- level

The Spend details dashboard has been enhanced to list site-level expenses, drilled down to the transaction level for a given duration. This is a list view which gives detailed information around spending like cost category, spend description, spend date, payment date, payee name and payment status.

COM-255, COM-268 and COM-269:   Site Summary Dashboard to get insights at site-level performance             

The Site Summary dashboard has been enhanced for probing into site-level analytics for a given Clinical study and for presenting on how the site of interest is performing on key site-level metrics.  It also shows how the site is performing with respect to related country average for each of the defined key metrics.

• Smart Search Powered by DaLIA

COM-545: Get more with Study Listings         

While querying on study listings, DaLIA response, has been enhanced, to show additional study details like Study Name, Therapeutic Area, Indication, Phase, Study Start Date, and Study End Date.

COM-856: Suggestive searches offered by DaLIA

Analyzing the user’s initial query, DaLIA has been enhanced to propose related queries or come up with suggested searches that will help the user to quickly ease his/her way into new insights and developments.

COM-962: Export tabular data in CSV format

DaLIA responses received in a tabular form can now be exported to a CSV file through a single click.

COM-123, COM-856, COM-996: Check Enrollment Performance

                            New intents have been added, to check enrollment performance on parameters listed below:

• Count of subjects enrolled that match the search criteria (for a study or country or site)
• Get date when subject enrollment was achieved with respect to the search criteria selected (for a study or country or site)
• Count of studies or countries or sites that match the searched enrollment criteria 
• List of studies or countries or sites that match the searched enrollment criteria

COM-281: Check Subject Screening Performance

                            New intents have been added, to check subject screening performance on parameters listed below:

• Count of subjects screened that match the search criteria (for a study or country or site)
• Get date when subject screening was completed with respect to the search criteria selected (for a study or country or site)
• Count of studies or countries or sites that match the searched subject screening criteria
• List of studies or countries or sites that match the searched subject screening criteria

COM-282, COM-823: Check status of Milestone for a study or site

This intent has been added, to give the status of milestone for a study or site along with some relevant details. A user can also search status for a study or site. For instance, status of study will give status for Last Subject Last Visit, % Sites Activated, Last Dose to Last Subject, Last Subject In, and Ongoing.

COM-576: Check Milestone Performance

This intent has been added to give the date when a specific milestone was achieved or approved at a study-level and site-level which in turn will help the user to draw comparisons across various sites on milestones achieved, for one or more studies.

COM-620: Veeva CTMS Adapter Update

Veeva CTMS Adapter has been enhanced to effectively consume Picklists and List of Values associated with it and store in database.

COM-848: New Veeva eTMF Adapter Update

Enhancements in new Veeva eTMF Adapter implementation have been done to resolve the issue of missing incremental data loads for a few workflows as a result of task_last_modified_date__v field being used as a HighWaterMark for incremental load.

COM-659, COM-663: USDM Data Model expanded to support insights around Study Financials 

In order to support the new Operations Insights around Study Financials, 2 new data tables have been introduced in USDM Data Model: siteexpendituredata (Expense Details per Site), siteexpendituresummary (Summary of Expenses on a Site).

COM-675: Expanded AE Table in USDM  

AE Table in USDM is expanded to include additional column for AE Outcome.

COM-483: USDM Data Model expanded to support multiple subject visits

In order to support multiple subject visit schedules for a study, 4 new data tables have been introduced in USDM Data Model: TVA (Trial Visits per Arm), SE (Subject Elements), TA (Trial Arms) and TE (Trial Elements). 

There are no bug fixes.

There are no new open issues.

Customers can submit issues via our support portal (Support.saama.com) or calling the support line (866) 619-9995 during normal business hours. For any other query customers can contact us on the email address: support@saama.com