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Submit when the science is done
Verisian automates the path from clinical trial to regulatory approval for drugs, biologics and medical devices: generating valid analyses, data, results, and submission documents.
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How Bayer uses the Verisian Platform for submissions
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The Verisian AI infrastructure is enabling Bayer to take big steps towards delivering our data caterer vision, where at least 80% of the busywork is automated by trustworthy and evidence-based AI.
Sascha Ahrweiler, VP, Head Statistical Programming & Analysis - Strategy & Operations, Bayer
Read case study
After your last patient visit, the science is done.
So why do submissions take months?
Months of work are spent on manual analyses, validation and preparing submission documentation, delaying your time-to-market. Regulators then need many months to make a decision.
Verisian unifies every document, specification, code, dataset, and result into a fully deterministic, reproducible, and traceable system.
It is the ground truth our AI agents use to produce analyses, data, results and submission documents. Your experts review, guide, and approve. AI does the work. Experts remain in control.
The result is trustworthy, traceable, evidence-based automation across analysis, submission, and regulatory review.
Compress analysis, submission, and regulatory review from months to weeks.
Automate data analysis
Use Verisian’s Agentic AI to generate your clinical data and results, validated against your study design. Weeks of manual programming and validation become outputs generated in hours your experts review and approve.
Generate key submission deliverables in minutes
Use Verisian to generate your most time-consuming submission deliverables in minutes: Define-XMLs, reviewers' guides, patient narratives, and CSR sections for a new drug or biologics submission, or clinical data documentation for a medical device submission. Your experts review and approve. Human in the loop, always.
Higher quality submissions mean faster regulatory approval
Submit your studies to regulators with access to the Verisian platform.

Higher quality, transparency and full traceability enable faster review and fewer health authority questions.

Answer Information Requests or Deficiency Letters in hours instead of days, with a full audit trail connecting every response directly to the code, data, and result it is based on.
Submit when the science is done
Verisian automates the path from clinical trial to regulatory approval: generating valid
analyses, data, results, and submission documents. Submit in days, not months.
Submit when the science is done
Verisian automates the path from clinical trial to regulatory approval: generating analyses, data, results, and submission documents. Submit in days, not months.
The Verisian Harness:
code is the source of truth
Learn how to make agentic AI trustworthy in clinical trials, with your experts in control, always.
Download white paper
Grounded in evidence.
Automated with AI. Overseen by experts
Learn more
Grounded in evidence.
Automated with AI. Overseen by experts
Learn more
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Latest from Verisian
Perspectives
Move Submissions Off the Critical Path
Sponsors take months between the last patient last visit of a final pivotal trial (LPLV) and submission, time that sits directly on the critical path for time to market. These months are largely spent on the production and validation of analysis results and the generation of submission documents, before the final submission package is assembled.
Andrew York
Tomás Sabat Stöfsel
Moira Daniels
October 7, 2026
Podcasts
The Evolution of Statistical Programming: How AI, Open Source & Traceability are Shaping the Future
Andrew York has over 30 years experience as a statistical programmer, and has played a leading role in shaping best practice in the industry. In this episode, Andy shares his unique perspectives on how the role of a statistical programmer has evolved, and how AI, open source, traceability and standards will shape the future of the industry.
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September 11, 2025
Perspectives
Metadata Automation is Failing: A Paradigm Shift is Coming
Existing technology, especially the promises around metadata-driven automation (MDA) and metadata repositories (MDRs), will never adequately address the fundamental problems of the industry. They promise to eventually automate 60-90% of all derivations and TLFs (depending on the complexity of the study).
Henning Kuich
August 14, 2025
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