Biostatistics & Programming

Biostatistics & Programming is a module within the ThoughtSphere platform designed for biostatistics and programming teams working on clinical trials. It combines purpose-built tooling with Agentic AI capabilities to support dataset generation, table/figure/listing (TFL) automation, and statistical modeling workflows, while keeping human oversight in place throughout the process.

Intelligent Dataset Generation

• Auto-maps up to 90% of SDTM variables using ThoughtSphere's patented mapping engine combined with Agentic AI capabilities.
• Converts raw clinical data into SDTM and ADaM datasets using R, Python, or SAS, with a robust SDK available to support additional programming languages.
• Includes a Data Export Configuration feature to produce validation-ready SDTM and ADaM submission packages.

Protocol-to-TLF Automation

• Agentic AI reads and interprets the protocol, Statistical Analysis Plan (SAP), and study metadata to automatically draft TFL shells and the underlying ADaM datasets.
• Provides a library of TFL shells that users can draw from and extend with new TFLs for future reuse.
• Reduces repetitive programming tasks, allowing biostatisticians to focus on data interpretation and insights.

Real-Time Modeling for Statistical Consulting

• Supports model development using real-time curated data as well as imported historical datasets and real-world evidence (RWE) data.
• Enables creation of AI/ML models to predict outcomes and identify patterns in complex, unstructured data.
• Includes automated scheduling, audit trails, and reusable templates to streamline statistical consulting workflows.

Biostatistics & Programming is part of ThoughtSphere's broader unified clinical data platform, which also covers areas such as study oversight, risk-based quality management, medical monitoring, safety case transformation, and data curation, among others.