ThoughtSphere Platform 1.16.1 — Powerful New AI Agents, Smarter Insights, and Enhanced Workflows

We’re excited to announce ThoughtSphere Platform v1.16.1 — delivering even more agentic AI
capabilities, richer analytics, and added DM controls to help your teams move faster with
confidence.

Agentic AI Enhancements

• Agentic Data Mapping: In the Clinical Mapping Workbench, a new Agentic Mapping
  option lets you map SDTM data with real-time explainability and human-in-the-loop
  control.
• Agentic Data Checks: Upload your Data Validation Plan or Study Protocol, and the
  ThoughtSphere Data Check Agent reads, identifies, and codes Data Checks
  automatically — seamlessly integrated into your workflows with oversight.

Smarter Safety Analytics & Dashboards

• Pivot Tables: Create and configure pivot tables directly in BI Designer for powerful,
  flexible data analysis that supports aggregation functions & nested grouping.
• New Dashboards & Charts:
  • Lab Test by Lab Code Chart: view all lab test results and lab ranges, for an
    individual participant, sorted by visit date.
  • Lab Test Vs Dosing Chart: track lab results by visit and correlate them with
    dosing events for each participant
  • Treatment Emergent AE Charts: visualize TEAEs by preferred term,
    severity-based segmentation and prevalence — elevating your safety
    surveillance.
  • Safety Summary – TEAE by PT: A new Clinical Analytics crosstab has been
    added to analyze the occurrence of Preferred Terms, Severity, and ARM.
  • Clinical Data Report and Comparison: compare clinical data reports across
    form versions for a complete overview

Added Data Management Controls

• Enhanced Data Check Configuration: Define Form OID, Item OID, and Recipient
  Group upfront to auto-fill during query creation, saving valuable time.
• Enhanced Smart Check Oversight: New option in Study Centric Properties to add
  Smart checks at Draft status instead of Active to ensure human oversight and approval
  before monitoring begins.

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!