Human-AI Orchestration for Clinical Operations

More studies. Same team. Every action audited.

More studies. Same team. Every action audited.

Schedule Demo

Human-AI Orchestration for Clinical Operations

More studies. Same team. Every action audited.

Schedule Demo

The shift

Start from the work. Shift it to agents.

Start from the work. Shift it to agents.

Start from the work. Shift it to agents.

Asteri begins with the human work your teams do today — the real SOPs, roles, and handoffs — then shifts it to governed agents one task at a time. The platform is the infrastructure that makes that shift safe, auditable, and always human-supervised where it matters.

Asteri begins with the human work your teams do today — the real SOPs, roles, and handoffs — then shifts it to governed agents one task at a time. The platform is the infrastructure that makes that shift safe, auditable, and always human-supervised where it matters.

Human today

Human today

Governed agent

Governed agent

TMF filing

TMF filing

Shifted to agent

Shifted to agent

Adverse-event triage

Adverse-event triage

Human-in-the-loop

Human-in-the-loop

Site-activation tracking

Site-activation tracking

Shifted to agent

Shifted to agent

Audit-readiness checks

Audit-readiness checks

Shifted to agent

Shifted to agent

The foundation underneath

Work Intelligence · Simulation Engine · Governed AI Agents

Work Intelligence · Simulation Engine · Governed AI Agents

Clinical development is one of the largest constraints on R&D productivity. Fragmented systems, manual analysis, and 700-step workflows slow every study down — so the platform automatically learns them and keeps the model live.

Clinical development is one of the largest constraints on R&D productivity. Fragmented systems, manual analysis, and 700-step workflows slow every study down — so the platform automatically learns them and keeps the model live.

Asteri brings data, governed agents, and business rules into one operating layer — the platform automatically builds a live model of the trial you can plan against before you commit resources to it.

“When you have humans, you don’t get consistency — people make mistakes. With one system, if you fix an error it fixes everywhere, instead of chasing every individual. That’s the biggest source of audit findings.”

“When you have humans, you don’t get consistency — people make mistakes. With one system, if you fix an error it fixes everywhere, instead of chasing every individual. That’s the biggest source of audit findings.”

Head of Clinical Operations

Global pharmaceutical enterprise

Proven impact

Impact where clinical operations feel the pressure most — startup, quality, and audit.

Impact where clinical operations feel the pressure most — startup, quality, and audit.

Impact where clinical operations feel the pressure most — startup, quality, and audit.

Consistency across every study

Inconsistency between people is the leading source of audit findings. Agents apply the same GCP checks and naming conventions to every document and every site — fix a rule once and it corrects everywhere.

Capacity where it is tightest

Startup carries the most headcount in a trial. Agents chase sites, run readiness checklists, and file documents so specialists stop doing manual admin — bringing 12-hour days back to eight.

Proactive audit readiness

A monitoring agent continuously checks filings against requirements and flags gaps before an auditor does — turning audit prep from a fire drill into a background process.

How it works

Three modules. One governed workforce.

Three modules. One governed workforce.

Three modules. One governed workforce.

Each module builds on the last. Together they make Human-AI Orchestration for clinical operations possible — the platform sees the work, tests the plan, then runs it.

Each module builds on the last. Together they make Human-AI Orchestration for clinical operations possible — the platform sees the work, tests the plan, then runs it.

Each module builds on the last. Together they make Human-AI Orchestration for clinical operations possible — the platform sees the work, tests the plan, then runs it.

01 · See the work

Work Intelligence

The platform automatically builds a live, task-level work graph of the trial — surfacing where duplication, bottlenecks, and AI-readiness actually are.

The platform automatically builds a live, task-level work graph of the trial — surfacing where duplication, bottlenecks, and AI-readiness actually are.

02 · Test the plan

Simulation Engine

Every agent and scenario is simulated against the real work graph before go-live — modeling outcomes, surfacing risk, and generating the GxP audit trail sign-off requires.

Every agent and scenario is simulated against the real work graph before go-live — modeling outcomes, surfacing risk, and generating the GxP audit trail sign-off requires.

03 · Run it

AI Agents

Governed agents — TMF Filing, Audit Readiness, Adverse Events — grounded in work reality and validated through simulation, purpose-built for clinical operations.

Governed agents — TMF Filing, Audit Readiness, Adverse Events — grounded in work reality and validated through simulation, purpose-built for clinical operations.

The result

Human-AI Orchestration

Humans and governed agents coordinated as one workforce across the trial — the right role in the loop at every handoff, every action auditable.

Humans and governed agents coordinated as one workforce across the trial — the right role in the loop at every handoff, every action auditable.

Built for clinical operations teams

The right worker — human or agent
— in the loop at every step.

The right worker — human or agent
— in the loop at every step.

The right worker — human or agent
— in the loop at every step.

Heads of Clinical Operations

Study Startup Teams

TMF & Quality Specialists

Data Management & Safety

Heads of operations · Clinical ops leads

See where agents add capacity across startup, conduct, and close-out — then reallocate people from manual admin to higher-value work. Grow study volume without growing headcount, and bring 12-hour days back to eight.

Heads of Clinical Operations

Study Startup Teams

TMF & Quality Specialists

Data Management & Safety

Heads of operations · Clinical ops leads

See where agents add capacity across startup, conduct, and close-out — then reallocate people from manual admin to higher-value work. Grow study volume without growing headcount, and bring 12-hour days back to eight.

The agent portfolio

Governed agents for every clinical workflow.

TMF Filing, Audit Readiness, Adverse Events Monitoring, and more — each validated before deployment and orchestrated alongside your teams.

Explore the Asteri AI agent portfolio

Skip to content
Skip to content
Skip to content