ThoughtSphere 1.15 Release Notes

We are thrilled to announce the latest enhancements to the ThoughtSphere Platform in version 1.15! This release delivers powerful new capabilities across the platform to further empower clinical data teams with efficiency, flexibility, and intelligent automation.

Key Updates in v1.15:

AI/ML Innovations

• LLM-Driven Controlled Terminology Mapping: Auto-resolution of raw values to CDISC controlled terminology code lists is now enhanced with Large Language Models, significantly reducing manual effort and improving accuracy.
• New AI Agent: Meet Klini, the platform’s conversational AI agent! Klini (beta version) is now available to answer clinical and operational questions from the study team, delivering insights quickly and enhancing the end-user experience.

Clinical & Operational Analytic Enhancements

• Improved Subject-Level Comparative Analysis: The subject-level review experience has been enhanced with new comparative analysis features, providing deeper insights into the patient’s journey.
• New SLA/KPI Query Reports: SLA and KPI query reporting capabilities have been expanded to include metrics for discrepancy aging, EDC query aging, and EDC query closure SLA performance.
• New Query Timeliness Dashboards: Query timeliness dashboards now include additional metrics, such as discrepancy-to-query creation lag time and All Query Dashboard views, to enhance operational oversight.

Data Management Upgrades

• New AE Duplicate Exception Listing: An out-of-the-box standard listing has been introduced to help identify duplicate Adverse Events at the subject level, eliminating the need for a study-specific listing.
• New Reconciliation Review Status: A new “On Hold” status has been introduced for reconciliation reviews, enabling better workflow management and prioritization of tasks.
• CTQ Parameter Display: Critical-to-Quality (CTQ) parameters are now prominently displayed across Data Management views, giving end-users a targeted dimension to prioritize reviews and focus on errors that matter.

Mapping Enhancements

• R Programming Available: Users can now use R Language to support the clinical data mapping process and configure data checks. This allows users to pick their preferred programming language and seamlessly implement mapping specifications and perform advanced data checks using R.
• Expanded SDTM Target Model Versions: The platform now supports mapping to multiple target model versions, including SDTM 1.4, 1.7, and 2.0, providing greater flexibility and compatibility for diverse mapping requirements across an organization.
• New Study-Level Target Data Model Configuration: Study-level target model configuration has been introduced, allowing users to tailor target models to align with specific protocol needs, ensuring more accurate and compliant workflows.
• Enhanced SDTM Define Package Generation: The process of generating Define.xml packages has been streamlined, improving efficiency and ensuring submission readiness.
• New SDTM Dataset Ingestion: Users can now ingest SDTM datasets, including Trial domains, and bypass the data mapping steps in the platform to streamline down-stream reviews and Define.xml package generation.

TLF Enhancements

• New Library of Tables, Listings, and Figures (TLF): A robust library of pre-seeded TLF shells is now available, enabling rapid TLF generation and consistency across studies.
• New Smart TLF Generator: SmartTLF functionality automates data mapping and the creation of TLFs directly from the library, virtually eliminating manual effort and accelerating timelines.

Want to Learn More?

To all our existing customers, let’s talk about the next steps to updating your platform version so you can capitalize on all the new features and capabilities! Please reach out directly to your customer support lead or contact us at support@thoughtsphere.com.

To non-existing customers that want to learn more about our latest release and see a product demo, reach out to our sales team at sales@thoughtsphere.com. We look forward to connecting with you!