Verisian Clinical Trial AI Platform

Verisian is an AI platform designed for clinical trial organizations, covering the full trial analysis lifecycle from study planning through regulatory review. It provides information infrastructure that connects documents, knowledge, and processes in a single environment, and is intended for statistical programmers, statisticians, data managers, medical writers, clinicians, and other trial experts. Integration is achieved through file transfer, making it compatible with any current or future study computing environment (SCE), storage, or computing infrastructure.

Bayer is among the organizations using Verisian for regulatory submissions. The platform supports both in-house teams and CRO outsourcing models, with the stated goal of reducing costs, improving quality, and providing transparent communication across operating models.

Core Capabilities

• Automates SDTM and ADaM validation workflows using full study traceability and AI, replacing time-consuming QC double programming with QA oversight.
• Generates define-XMLs and drafts Study Data Reviewer's Guides (SDRGs) and Analysis Data Reviewer's Guides (ADRGs) directly from source code, data, and TLFs.
• Ensures CDISC and regulatory data compliance across FDA, PMDA, and NMPA requirements.
• Automates study integrity analyses to support submission readiness within hours.
• Supports response to internal and regulatory inquiries across documentation, raw data, SDTM, ADaM, and TLFs with full traceability.

Trial Analysis Lifecycle Coverage

• Planning: Defines study specifications with visibility into existing metadata, data, and code. Allows investigation of study structures, domains, variables, and derivations side by side, and extraction of reusable code templates from related studies.
• Onboarding: Provides programmers with full study traceability across documentation, code, macros, variables, data, TLFs, and their relationships, with the aim of reducing onboarding time by 50–80%.
• Programming: Gives programmers transparency into how every variable, dataset, and TLF is produced. Detects code quality issues, unused code, duplicate derivations, and faulty logic. Supports macro-resolved code exploration across CDISC-compliant and legacy studies.
• Validation: Replaces double programming with AI- and traceability-powered validation, providing full transparency into study data and accelerating validation cycles.
• Submission: Automates generation of define-XMLs and draft reviewer's guides, ensuring documentation consistency with the underlying analysis.
• Regulatory Review: Uses full study traceability to respond to regulatory inquiries in detail, with the stated capability of responding up to 10 times faster.

Platform Architecture and Integration

• Cloud-native architecture that integrates with any infrastructure via simple file transfer, requiring no complex integration work.
• Designed to make studies AI-ready within one day of onboarding.
• Provides a unified environment for documents, knowledge, and processes across all expert roles involved in clinical trials.
• Includes distinct hubs: Statistical Programming Hub, Medical Writing Hub, Real-time Hub, and Submission Hub.

Verisian positions its platform as applicable to organizations seeking to reduce time-to-market through faster regulatory review and higher-quality submissions, with deployment achievable without changes to existing infrastructure.