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 v3.2.

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

COM-641, COM-756, COM-1423 and COM-1411: ‘Site Activation Dashboard - Study’ that provides a summary of the Site activation, Study site visit and Site progress status of the Clinical trial over time

The Study Site Activation Dashboard draws out a comprehensive analysis on site activation, to assist with identifying the areas of optimization for a healthy Study Start Up. The dashboard displays site activation behaviour over the Enrollment phase of the study, revealing the actual number of sites activated compared to plan, and projecting site activation over time or across participating countries.

The core activities of a clinical study happen at a site, and activating an optimal number of sites in less time in highly desirable for overall study access.

COM- 618, COM- 619, COM-1417: ‘Enrollment Dashboard- Study’ to analyze progress of enrollment over time as well as enrollment funnel with subject disposition reason for a study and subject completion by visit over a duration

The Study Enrollment Dashboard displays real-time enrollment information to assist in the tracking and management of patient screening and enrollment. The dashboard reveals the actual number of subjects at each step in the enrollment pipeline and actual subject completion on every visit. Achieving patient recruitment goals is critical for the successful completion of a clinical trial.

COM-830, COM-884 and COM-1604: ‘Data Metrics Dashboard- Study’ gives an overview on the progress of the study of interest according to its planned data points, to analyze details around data management like data entry rate, SDV percentage and primary endpoints around the study of interest

The Data Metrics Dashboard enables users to track, compare, and manage overall study data collection progress and analysis readiness. The primary objective of Clinical Data Management processes is to keep erroneous and missing data at a minimum, while trying to gather the maximum amount of data for analysis. High-quality data should be accurate and suitable for statistical analysis.

COM-807, COM-808 and COM-1477: ‘Safety Summary Dashboard- Study’ gives details around adverse events and serious adverse events, relatedness with body system or with IP and severity of event for the study of interest.

The ‘Safety Summary Dashboard- Study’ displays real-time Serious Adverse Events (SAE) and Adverse Events (AE) for a study, to assist with monitoring, tracking, and identifying safety signals that require attention. Early safety signal detection supports better patient protection and saves development costs. Monitoring patient safety during clinical trials is a critical component throughout the drug development lifecycle.

COM-828, COM-839, COM-1449 and COM-1096: ‘Quality Measures Dashboard- Study’ gives details around protocol deviations over a time period, Reason for PDs and other issues around the study of interest.

The Quality Measures Dashboard provides an overview around protocol deviations (PDs) and other study issues, to assist with identifying impediments and taking appropriate mitigation actions. Protocol deviation rates and average PD (site|subject|visit|crf) are calculated, categorized, and tracked over time and region to assist in identifying the major reasons for protocol deviation and regions most impacted. Additionally, tracking site-reported issues by status for the study region helps users plan corrective measures.

Note: User can search these new dashboards directly in the “Ask DaLIA” smart search box at the top of the screen. Alternatively, you can use breadcrumbs within Operations Insights to select “Study” focus, and these dashboards would be available under the “Analytics” selections.

• Enhancements in Smart Search Powered by DaLIA

COM-804: New Feature- Study Name for DaLIA Questions and Responses

DaLIA is now able to respond with a study name and/or study ID in the sentences or questions and provides an appropriate answer. Users can see the study name in the response wherever applicable.

COM-1318: New feature- Suggestive and Auto completion of DaLIA queries

Analyzing the user’s initial query, DaLIA is able to propose related queries or come up with suggestive questions, auto completion of questions, list of recommended questions and suggestive KPIs intended to enable users to easily access the new insights.

COM-1384: New feature- Like and Dislike for DaLIA response

DaLIA is able to understand synonyms of OOB milestones and provide correct output.

COM-1419: Study and Site Milestone Synonyms

                            DaLIA is able to understand synonyms of OOB milestones and provide correct output.

COM-1448: Enhancement of DaLIA output screen

                            DaLIA output screen is enhanced with following features: 

• Maintain filter hierarchy for all DaLIA queries.
• Output to be divided into 3 components:
  • Summary Card
  • Listing Card
  • Link to KPIs 
• Includes suggestive questions
• Includes Like-Dislike feature
• DaLIA responses are received in a tabular format that can be exported to a CSV file with a single click. 

COM-1593: Column sequence to display at Study, Region, Country and Site

DaLIA output screen is enhanced to maintain hierarchy and sequence of columns to display listing at a glance to give a better experience to users.

COM-164: New Intent – Query Resolution Time

DaLIA trained to return query resolution time for study, country, and site entity.

COM-983, COM-997 and COM-998: New Intent – Top N and Bottom N Studies, Countries, and Sites for Query Status

DaLIA provides a list of top N or bottom N studies, countries, and sites based on query status counts in a listing format. The listing provides metadata such as: Study ID, Study Name, Region, Country, and Count of (Open/Answered/Closed/Cancelled) Queries, TA, Indication, and Phase of Study. 

COM-999, COM-1001, and COM-1003: New Intent - Top N or Bottom N Studies, Countries, and Site for Subject Enrollment

DaLIA provides a list of top N or bottom N studies, countries, and sites for planned enrollment count, actual enrollment count and enrollment percentage (%).

COM-905 and COM-1611: New Intent - Query Counts

DaLIA trained to return count of open, answered, and closed queries for study, country, region and site entity. The listing will also provide additional metadata such as: Study ID, Study Name, Region, Country, Count of (Open/Answered/Closed/Cancelled) Queries, TA, Indication, and Phase of Study. 

COM-907: New Intent - Query Answer Time

DaLIA trained to answer queries related questions and provide output on query answered time for study, region, country and site entities. 

COM-1000 and COM-1004: New Intent - Top N or Bottom N Studies and Sites for Milestones

DaLIA provides a list of top N or bottom N studies and sites for achieved or non-achieved milestones. The listing includes information for Study ID, Study Name, Site ID, Site Name, and Days delayed to achieve the milestone.

COM-1383: New Intent - Screen Failure, Enrollment, Withdrawal, and Randomization Fail Rates

DaLIA trained to extract screen failure, enrollment, withdrawal, and randomization failed rates for the following entities: Study, Site, Region, Country, CRA, TA, Indication, Phase, CRO/Sponsor, Investigator, and Program. 

COM-1391: New Intent – Open Query Rate

DaLIA trained to calculate open query rate for study, region, country, and site entities. 

COM-1404: New Intent – Count of Study and Site Milestones

DaLIA trained to return count of milestone events for selected study or site.

COM-1375: Updated Intent – Subject Disposition Counts

DaLIA trained to return subject disposition counts for study, region, country and site entities for the following disposition events: All Subjects, Enrolled, Withdrawn, Screened, Failed Screen, Consented, Randomized, Evaluable, Completed Treatment, Early Terminated treatment.

COM-136: Updated Intent – Planned and Actual Site Activation Counts, Time and Rate

                            DaLIA retrained to deliver on the following:

• Count of planned sites for study entity
• Count of active sites for study, region, country, investigator, and CRA entities
• Site Activation Time for Study, Country, Region
• Site Activation Rate for Study, Region, Country
• List of studies with site activation rate greater than X

COM-1378, COM-1381: Introduction of new intents and entities enabling additional insights

• RACT (Risk Assessment and Categorization Tool)

COM-1375: Updated Intent – Subject Disposition Counts

Risk Assessment and Categorization Tool (RACT) is a new LSAC product/ module that enables users to identify, categorize and measure risk in a collaborative way. The primary component is the “RACT Console” that is inspired by Transcelerate RACT Guidelines. This module will be owned and configured by the user, they will go in and easily configure risk categories/subcategories that need to be assessed, justified, measured, and tracked at the study level. The RACT Console will be versioned, exportable, and signed-off by the end user. 

COM- 941: Creating Custom RACT template

RACT Author can work closely with business stakeholders to gather all custom RACT requirements in order to configure a custom RACT template that can be used for new and existing studies. It will give the author the ability to select category or subcategory from Out of the Box list or create any custom category or subcategory.

COM- 939: Selecting between OOB RACT/Custom RACT Template

RACT console gives the ability for the Author to access the OOB and custom created RACT templates and assign a template to a new or existing study/studies.

COM- 930: Risk Category Console

                            This console will display all Risk Subcategories associated with a Category, which allows the user to:

• Enable/Disable any risk subcategory
• Edit Risk Question for Discussion
• Edit Risk Sub Consideration
• Provide Risk Impact and Probability Score
• Select Risk Detectability
• Provide Risk Weightage
• Add Functional Plan Impacted
• Add Mitigation Action Plans

COM-969: Risk Mitigation Console

Users will have an ability to select Mitigation Action from the Mitigation Library associated with each subcategory or can add a new mitigation action for a subcategory.

COM-967: Audit and Traceability

                            RACT users will have the ability to track all updates and modifications on RACT in terms of:

• Object Type
• Action By
• Operation
• Timestamp
• Target

COM-1246: Signoff RACT

RACT Author needs to enable a RACT for a given study and assign a task to the appropriate stakeholder to get RACT approved and signed off. Stakeholders will have the ability to either reject or approve the RACT.

COM-966, COM-1682: Export RACT as a document, RACT console export

                            RACT can be exported at a console level or individual RACT assessment level.

• At console level RACT for all studies can be exported in excel format which will provide comparison of Risk scores and Mitigation Actions between all studies.
• Assessed RACT can be exported at any point of time in an excel format from Risk category console, which will give details of Risk score, functional plan, mitigation action, risk weightage at each category and subcategory level.

COM-1484: Access Enablement within Architect mode

A user of the RBQM Module can have View or Edit access to Oversight Scorecard and/or RACT Console. These access permissions can be managed from within the User Management feature of LSAC. Here view or edit level access for Oversight Scorecard and/or RACT Console can be modified by the User Administrator. 

COM-1485: RBM module name change to RBQM

LSAC RBM module/ solution is now rebranded as LSAC RBQM.

• Enhanced Data Review Tracking

COM-837: Create Data Review Set with Review Roles

Enables a Reviewer to create a Data Review Set, assign review roles and track progress of data review by function. A Data Review Set can contain one or more dynamic line listings. Multiple Review Roles can be assigned for a Data Review Set.

COM-833: Data Selection Options while generating Review File for download

Reviewers can filter and select records based on Study, Site, Subjects, Data update range. Additional Data Selection options based on record review status are also available. These are:  

• Unreviewed by me
• Unreviewed by my Review Role
• All Records

COM-834: Review file to have additional columns for each review role

Review file contains columns Current Team, Mark Current Review, and Add Review Comments to enables reviewers to mark a specific row as reviewed. 

Columns Last Reviewed Flag, Last Reviewed Date, Last Reviewed By, and Last Reviewed Comments display past review status for a row. For a data row, all past reviews can be seen for a specific date range. Hence as part of the review process a Review team can see the review comments entered by another Review Role, enabling enhanced collaboration. 

COM-835: Importing and processing Reviewed Data

A User can import their reviewed set via the Import Review button on the landing page as and when one completes new reviews. For a valid import file, after processing the upload file, the system displays a Confirmation message in terms of valid review records. In case of invalid file system displays a needful error message. 

COM-836: New Data Review Summary Report: Summary of Reviewed Data by Review Roles

Enables a role such as ‘Study Manager’ to keep track of the review status for Data Review Sets across Study and across Review Roles so as to assess readiness for database lock.

COM-1086: Console to show Data Review File Upload/Download Transactions

A Reviewer can check the download and upload history for a Data Review Set, for better coordination across Review Teams.

• Enhancements in the USDM Data Model

COM-1436: USDM Data Model expanded to support the ‘Site Activation-Study’ dashboard for country level chart

A new table “std_sitecountrycode” is added in USDM model to support the Site Activation dashboard in Study focus for country level chart.

COM-1072: USDM Data Model expanded to support the ‘Enrollment-Study’ dashboard for country level chart

A new table- “countryplannedrecruitment” is added in USDM model to support the Enrollment dashboard in Study focus for country level chart.

COM-1443: USDM Data Model expanded to USDM CM, and MH Tables updates

Additional CM, and MH fields were added to the CM and MH Table. It was currently required to capture additional source data that is required for custom reports.

COM-902: USDM Data Model expanded to support enhancements in Smart Search powered by DaLIA

Column study name is added to all the tables used by DaLIA to support DaLIA search on Study Name.

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