ThoughtSphere Platform Release v1.17.2

We’re excited to announce version 1.17.2 of the ThoughtSphere Platform – continuing our commitment to AI-orchestrated clinical intelligence across every stage of development!

This release introduces the new BIOS Agent for ADaM and TLF automation, and expands oncology and patient-level analytics. Other updates include automated country data ingestion from InForm EDC, enhanced mapping, submission workflows, and ClinDM improvements.

Release Highlights

Agentic AI Highlights

NEW BIOS Agent:

An AI-powered statistical programming co-pilot that automates the generation of ADaM datasets and TLFs —
interpreting study documents, identifying required outputs, and producing submission-ready code.

• Protocol & SAP Interpretation – Reads uploaded protocols and Statistical Analysis Plans to
  identify required datasets and outputs.
• Submission-Ready ADaM Generation – Produces ADaM datasets aligned with CDISC standards,
  complete with executable code.
• Multi-Language TLF Code Generation – Generates Tables, Listings, and Figures with
  executable code in Python, R, or SAS.
• End-to-End Workflow Automation – Streamlines the path from protocol ingestion to
  submission-ready output without manual programming overhead.

FINE-TUNED Data Validation Plan Agent:
Enhanced Agentic DVP generation that looks across the protocol and CRF structure to build a complete DVP,
producing a more accurate, and holistic plan.

FINE-TUNED Expression Agent:
Improved rule evaluation and execution logic for more reliable generation of Python, R, and JavaScript
expressions.

NEW AI Governance Controls: Added governance and auditability controls across all AI
interactions, providing clearer oversight of agent activity across the platform, including:

• Enhanced Live and Exportable Explanability Reports for CTQ, Data Validation Plan Agent, SDTM Mapping and
  BIOS Agents.
• Prevent data loss by disallowing deletion of Klini chats in the platform

Together, these enhancements continue ThoughtSphere’s progression toward an Agent-powered data orchestration
platform – where digital coworkers handle the heavy lifting of dataset creation, validation, and reporting.

ClinSCI™

Enhanced Mapping Execution & Support for Pinnacle 21 Imports

ENHANCED P21 Worksheet Import: Added support for importing Pinnacle 21 standard worksheets (for ARM
and VLM data) – accelerating standards setup and submission readiness.

ENHANCED Mapping Execution: Improved execution of Python and expression-based mappings, along with
stronger mapping comparison and metadata handling.

ClinDM™

Centralized Validation & Streamlined Review Workflows

ENHANCED Query Creation: UI enhancement to display source data in tabular format for easier
analysis and query specification definition. Available in My Check Reviews.
EXPANDED Data Check Authoring: Data Management Lead (DML) role can now create and be reassigned
Data Checks, expanding flexibility in validation ownership.
Stabilized Core Review Workflows: Improved reliability and stability of ClinDM functionality,
ensuring consistent and predictable behavior.

ClinHUB™

Automated Ingestion & Smarter Outbound Data Flows

NEW Automated Country Data Ingestion: Country data is now automatically ingested from InForm EDC,
reducing manual setup and ensuring consistency across studies.
EXPANDED Dataset Export: Raw and transformed datasets can now be exported based on a specified date
— improving traceability for time-bound analyses.
ENHANCED Python Script Management: Enhanced UI with version control, script status visibility,
comparison functionality, and publishing capabilities.
ENHANCED Clinical Analytics Mapping: Smart Map (manual and AI based) functionality is now defaulted
to 14 predefined domains for Analytics mapping; new Study Metadata function added.
EXPANDED Platform Table Search: Logic operators such as &&, >, and similar are now
supported in the Search Row of platform tables, enabling more precise filtering across the platform.

ClinBI™

Deeper Oncology Insights & Richer Patient-Level Visualizations

NEW Objective Response Rate Chart: A new bar chart added to the Oncology analytics suite,
complementing existing waterfall, spider, and swimmer plots.
EXPANDED Comparative & Cross-Variate Analysis: Dosing data is now available across comparative and
cross-variate charts for richer multi-dimensional analysis.
ENHANCED Graphical Patient Profile: Multi-page export now grouped by domain — improving readability
and review efficiency for patient-level data.
ENHANCED Source Data View: Now supports both hierarchical and tabular layouts for more flexible
review of source data.

A More Automated, Submission-Ready Clinical Platform

Version 1.17.2 marks another major step toward fully integrated agentic clinical operations – introducing the
BIOS Agent to automate ADaM and TLF generation, deepening AI capabilities across validation and mapping, and
enriching the analytics layer with new oncology, dosing, and patient-level views.

With expanded automation across statistical programming, ingestion, and submission workflows, ThoughtSphere
continues to redefine what end-to-end clinical data intelligence can achieve.

Learn More

Existing customers: contact your Customer Success Lead or
support@thoughtsphere.com to schedule your upgrade.

New to ThoughtSphere? Request a demo at sales@thoughtsphere.com
and see how Agentic AI is transforming clinical data operations.