ThoughtSphere Platform Release v1.17

We’re excited to announce version 1.17 of the ThoughtSphere Platform — advancing our mission to make clinical development faster, smarter, and more connected.
This release expands Agentic AI capabilities across several modules, enhances data governance and automation, and delivers a more intuitive user experience from ingestion to insight.

Release Highlights ClinHUB™ Smarter Data Ingestion & Integration

• Expanded Flat File & API Support: Broader delimiter options and new REST/Veeva API endpoint setup streamline multi-source ingestion.
• Auto-IDD for Inform ODM: Automatically imports metadata and clinical data, reducing manual setup time.
• File Metadata Validation: Built-in validation ensures clean, auditable imports.
• Flexible Data Exports: Streaming retrieval, timestamped outputs, and auto-synced column updates improve traceability and scalability.

ClinBI™ Faster Insights with Enhanced Dashboards

• Comprehensive Clinical Data Dashboard: All mapping types, including custom ones, now display for a comprehensive cross-study view.
• Early SAE Signal Detection: New out-of-the-box QTL logic provides monthly SAE monitoring with lower detection thresholds for proactive oversight.

ClinSCI™ AI-Powered Programming & Standards Governance

• Agentic AI Expression Builder: Generate Python, R, or JavaScript expressions from natural-language prompts.
• Agentic Trial Domain Extraction: AI reads uploaded protocols and automatically extracts trial domain metadata.
• Enhanced Controlled Terminology & ADaM Integration: Manage multiple CDISC CT versions, auto-resolve terminology, and configure ADaM datasets directly within the study model.
• TLF Designer Upgrades: Added approval workflows, view version snapshots, and multi-level table headers with automatic total columns.

ClinQ™ Agentic Risk-Based Quality Management

• Agentic Risk Analysis: New Agentic AI performs KRI reviews and surfaces key insights and recommended actions to the reviewer
• Agentic CTQ Configuration: Upload a protocol and let AI generate Critical-to-Quality factors to support a Quality-by-Design setup.
• Cross-Linked Dashboards & Risk Plans: Dashboards and datasets now automatically appear in KRIs, Medical Reviews, QTLs, and Listing Reviews — providing instant context.
• Streamlined Review Experience: Unified action tracking, attachment management, and visual trigger displays simplify navigation and interpretation.

ClinDM™ Accelerated Data Management & Validation

• Agentic AI Test Data Generator: Instantly create synthetic test datasets across study forms and SDTM domains to validate data checks.
• Smart Data Check Defaults: Configure global rule defaults for consistency and control.
• Contextualized Data Reviews: Link dashboards and data domains directly to check rules for richer, context-aware discrepancy review workflows.

A Smarter, More Connected Platform

The 1.17 release continues to strengthen ThoughtSphere’s position as the industry’s only end-to-end data orchestration platform — uniting AI, automation, and human insight across every stage of the clinical data lifecycle.

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.