Altio Decision Intelligence
Better Decisions. Faster.
AI for life sciences.
Altio turns the regulated documents and data you rely on, internal and external, into a longitudinal record that becomes one institutional memory. Built once at the core, that record carries forward as decisions move from safety to clinical, regulatory, quality, and beyond. Every answer traces back to the exact passage that required it, so review is checking the work rather than redoing it.
Is this signal new, or the same one we assessed eighteen months ago under a different name?
Internal
It is the same signal. The pattern flagged this week matches the assessment closed in February 2025, recorded then as “cytokine storm” in the case narratives1, and the committee's rationale is carried forward on the product record2.
Read from
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1
Signal Assessment SA-2025-004Internal Narrative review confirmed that events reported as “cytokine storm” met the case definition applied to cytokine release syndrome in this assessment.
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2
Safety Committee Minutes, Feb 2025Internal The observed pattern is consistent with the established CRS profile; signal closed with routine monitoring.
Powered by Altio COG™, patent pending, the obligation engine behind every record.
- EU AI Act minimal/limited risk, not high-risk
- ISO/IEC 42001 AI management
- 21 CFR Part 11 & Annex 11
- CIOMS AI in pharmacovigilance
Our mission
We help people live longer, healthier lives by enabling better, faster decisions.
Our thesis
In regulated science, governance is not the brake on AI adoption: it is the enabler.
The conservatism of pharmacovigilance is rational: you have to prove a system before you trust it. Altio treats that as the design starting point, not an afterthought.
Teams that run on audit-ready infrastructure deploy faster, pass inspection, and earn the confidence of health authorities. That is what the platform is built to do. The same record and the same discipline extend wherever a decision must be traced back to evidence, not just safety.
What it produces
Four workflows, one way of working.
Ask in plain language, read the answer, and open the passage behind every statement.
Signal assessment
Evidence assembled across data and documents, with prior assessments surfaced.
See the sessionHA RFI response
One section per agency question, cited to source and dual-signed before release.
See the sessionSafety committee pack
Assembled from the record, with every figure anchored to the row it came from.
See the sessionClinical study report
Drafted and numbered to the ICH E3 guideline, with tables built from the data.
See the sessionHow it works
An intelligence layer above your validated systems.
Altio sits above the systems you already run. It ingests documents and data across sources, builds the longitudinal record, and produces audit-ready outputs, replacing uncontrolled tooling with traceable, reproducible work.
It reads
- ICSRs and case narratives
- PSURs, DSURs, and literature
- Labels and health-authority queries
- Your own assessments and minutes
It produces
- Signal assessments
- Health-authority responses
- Safety committee packs
- Clinical study report sections
Each one drawn from the same institutional memory, extending to CTD and regulatory work, then medical affairs and evidence, as modules come online, with PBRER as a natural progression built with a design partner.
Connects to the stores you already run. Intake draws on public data such as FAERS alongside the documents you bring from your safety database, literature, and document management system, and signed deliverables flow downstream to Veeva Vault by API.
How the work is controlled
Nothing leaves without a named reviewer.
The same discipline applies whichever deliverable you are working on.
- DraftedIn your own template, every statement cited to its source.
- ReviewedPassed to a named reviewer, with comments recorded and resolved.
- SignedPart 11 e-signature, each version kept on an immutable trail.
Track record
Two decades of senior R&D experience, applied to AI in regulated environments.
Outcomes
What deployment delivers.
- Faster insight generation from safety and regulatory documents
- Earlier signal identification across PV data sources
- Audit-ready outputs that hold up to inspection
- Operational efficiency at human-in-the-loop scale
- Regulatory readiness across jurisdictions and products
- Expert capacity redirected to expert judgment
Team
Built by people who have done the work.
Direct operating experience in pharmacovigilance, clinical systems, and regulatory technology, and the AI architecture to put it into production.
Arvind Bellur
Founder & CEO
Evren Yucekus-Kissane
Co-founder & CTO
Meenal Patwardhan, MD, MHSA
Senior Medical Advisor
Daniel Prins
Platform Security Lead