Verisian

Verisian is a clinical trial AI platform that provides information infrastructure for deploying AI across clinical trial analysis, validation, submission, and regulatory review workflows. The platform serves a range of roles within life sciences organisations, including statistical programmers, statisticians, data managers, medical writers, and clinicians, and is designed to work with both in-house teams and CRO outsourcing models. Bayer is among its named customers.

Verisian integrates with any existing infrastructure through simple file transfer, requiring no complex technical setup. The platform is cloud native and compatible with any current or future study computing environment (SCE), storage, or computing setup, allowing organisations to become operational within a day.

Platform Modules

• Statistical Programming Hub: Provides full study traceability, allowing programmers to explore documentation, code, macros, variables, datasets, TLFs, and their relationships. Supports onboarding new programmers to studies 50–80% faster and enables root cause analysis to be reduced from hours to minutes.
• Medical Writing Hub: Supports the generation of submission documentation including define-XMLs, draft Study Data Reviewer's Guides (SDRGs), and Analysis Data Reviewer's Guides (ADRGs), all derived from the underlying code, data, and TLFs.
• Real-time Hub: Enables researchers and regulators to analyse and monitor studies transparently in real time.
• Submission Hub: Automates study integrity analyses and prepares complete submission packages, with the goal of making organisations submission ready within hours.

Core Capabilities

• SDTM and ADaM validation automation: Replaces traditional double programming with AI- and traceability-powered validation. Ensures CDISC and regulatory data compliance across FDA, PMDA, and NMPA requirements.
• Submission documentation generation: Automatically generates define-XMLs and drafts reviewer's guides that are guaranteed to be consistent with the underlying analysis, reducing documentation preparation to hours.
• Study planning and specification: Allows users to define study specifications with full visibility into existing metadata, data, and code. Supports investigation of study structures, domains, variables, and derivations, and enables extraction of reusable code templates from related studies.
• Full study traceability: Provides complete 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 or legacy studies.
• Regulatory inquiry response: Uses full study traceability to respond to internal and regulatory inquiries across documentation, raw data, SDTM, ADaM, and TLFs, with the aim of reducing response time by up to 10x.

Deployment and Integration

• Integration is achieved through file transfer only, with no complex integrations required.
• Compatible with any SCE, storage, or computing environment, current or future.
• Cloud native architecture.
• Designed to support both in-house teams and CRO outsourcing operating models.
• Studies can be made AI-ready within one day of getting started.

Regulatory Compliance

• Supports compliance with CDISC standards including SDTM and ADaM.
• Covers regulatory requirements across FDA, PMDA, and NMPA.
• Aims to improve submission quality to preempt regulatory inquiries and accelerate regulatory review timelines.

Company Background

• Verisian operates as a fully remote company and maintains a publicly accessible company handbook describing its working practices.
• The company's stated focus is on making clinical trial science transparent to companies, regulators, and patients, and on accelerating patient access to new treatments.
• Verisian is building a community for those working in clinical research and public health authorities, and hosts in-person and virtual community events.

Verisian covers the full clinical trial analysis lifecycle from planning and onboarding through programming, validation, submission, and regulatory review, with the stated goal of reducing time-to-market by enabling faster and higher-quality regulatory submissions.