Verisian | Automate Clinical Trial Submissions with AI

How Bayer uses the Verisian Platform for submissions

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

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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.

Thank You