The cold-start problem in drug discovery isn’t inconvenient — it’s a $1.4B problem. Every AI session re-analyzes the same failed compounds, same targets, same assay data. CLEOS eliminates that waste. FDA’s 2025 draft guidance on AI in regulatory submissions explicitly requires audit trails and provenance for any AI-generated content in IND, NDA, or BLA filings.
The Problem
The $1.4B average drug development cost is driven partly by redundant work — re-analyzing known failures, re-reviewing established literature, re-briefing AI on campaign context that was captured and then lost. CLEOS solves the compounding inefficiency at its root.
The Solution
Three capabilities that eliminate the context waste compounding drug development costs, satisfy FDA provenance requirements, and enable multi-site trial coordination.
Why the Math Works
The unit economics of drug development make even small efficiency gains worth tens of millions. CLEOS delivers large efficiency gains.
Regulatory Alignment
FDA’s AI regulatory framework is developing rapidly. CLEOS is built to satisfy not just current requirements, but the trajectory of where FDA is heading.
Buyers
Pharma AI governance spans computational science, regulatory affairs, clinical operations, and data leadership.
See how CLEOS eliminates discovery context waste, generates FDA-ready provenance documentation, and enables multi-site trial coordination — all from one infrastructure layer.