LIFE SCIENCES

Built for the complexity of regulated work

LIFE SCIENCES

Built for the complexity of regulated work

LIFE SCIENCES

Built for the complexity of regulated work

Asteri is purpose-built for the most regulated work on earth, where every action must be auditable and every agent governed.

Asteri is purpose-built for the most regulated work on earth, where every action must be auditable and every agent governed.

Asteri is purpose-built for the most regulated work on earth, where every action must be auditable and every agent governed.

THE SHIFT

From an all-human workforce to a governed hybrid one.

Same headcount. Same regulators. Same therapeutic ambition. A fundamentally different operating model.

Before

All-human workforce

Manual sprawl across 21 systems, 150+ SOPs, and 700+ process steps per program.

Manual SDV
AE intake
Site monitor
SOP author
CRF lock
Deviation log
CAPA draft
QA review
eCTD prep
Lit. screen
ICSR file
Pub plan
Med inq.
Site act.
Vendor mgmt
+ 686 more
0+
Manual steps
0.0 yr
Cycle
$0M+
Per trial
After

Governed human–AI workforce

Routed, audited, and orchestrated as one team — every action signed back to the work graph.

● AI Agents
● Humans
SDV Agent
Medical Monitor
AE Monitor
QA Sign-off
Submission Drafter
Reg Strategy
SOP Generator
Trial Lead
Reg Intelligence
CRA Escalation
Site Coordinator
Steering
0.0×
Throughput
0%
Auto-routed
0.0%
Rework rate
AsteriAsteri

Same regulators. Same therapeutic ambition. A fundamentally different operating model.

THE SHIFT

From an all-human workforce to a governed hybrid one.

Same headcount. Same regulators. Same therapeutic ambition. A fundamentally different operating model.

Before

All-human workforce

Manual sprawl across 21 systems, 150+ SOPs, and 700+ process steps per program.

Manual SDV
AE intake
Site monitor
SOP author
CRF lock
Deviation log
CAPA draft
QA review
eCTD prep
Lit. screen
ICSR file
Pub plan
Med inq.
Site act.
Vendor mgmt
+ 686 more
0+
Manual steps
0.0 yr
Cycle
$0M+
Per trial
After

Governed human–AI workforce

Routed, audited, and orchestrated as one team — every action signed back to the work graph.

● AI Agents
● Humans
SDV Agent
Medical Monitor
AE Monitor
QA Sign-off
Submission Drafter
Reg Strategy
SOP Generator
Trial Lead
Reg Intelligence
CRA Escalation
Site Coordinator
Steering
0.0×
Throughput
0%
Auto-routed
0.0%
Rework rate
AsteriAsteri

Same regulators. Same therapeutic ambition. A fundamentally different operating model.

THE SHIFT

From an all-human workforce to a governed hybrid one.

Same headcount. Same regulators. Same therapeutic ambition. A fundamentally different operating model.

Before

All-human workforce

Manual sprawl across 21 systems, 150+ SOPs, and 700+ process steps per program.

Manual SDV
AE intake
Site monitor
SOP author
CRF lock
Deviation log
CAPA draft
QA review
eCTD prep
Lit. screen
ICSR file
Pub plan
Med inq.
Site act.
Vendor mgmt
+ 686 more
0+
Manual steps
0.0 yr
Cycle
$0M+
Per trial
After

Governed human–AI workforce

Routed, audited, and orchestrated as one team — every action signed back to the work graph.

● AI Agents
● Humans
SDV Agent
Medical Monitor
AE Monitor
QA Sign-off
Submission Drafter
Reg Strategy
SOP Generator
Trial Lead
Reg Intelligence
CRA Escalation
Site Coordinator
Steering
0.0×
Throughput
0%
Auto-routed
0.0%
Rework rate
AsteriAsteri

Same regulators. Same therapeutic ambition. A fundamentally different operating model.

FUNCTIONS

Where orchestration and regulated agents start.

Asteri spans the whole enterprise — but human–AI orchestration and regulated agents deploy in these six functions first.

01 Pharma R&D

Target discovery to candidate selection.

Mine literature, patents, and internal experiments for novel targets. Triage and prioritize candidates with full provenance back to source data.

02 Clinical Operations

From protocol design to study closeout.

Author protocols, activate sites, monitor data, and track endpoints across 21 systems — with auditable handoffs at every step.

03 Regulatory Affairs

Submissions, responses, and intelligence.

Draft eCTD submissions, track regulatory commitments, and stay ahead of evolving guidance — across FDA, EMA, PMDA, and beyond.

04 Quality

GxP compliance, by design.

Maintain SOPs, manage deviations, route CAPAs, and prep for audit — with model versions and reasoning steps captured by default.

05 Pharmacovigilance

Signal detection at scale.

Triage adverse events, screen literature, monitor real-world signals, and meet reporting deadlines — every case routed and reviewed.

06 Medical Affairs

Medical content, MSL workflows, congresses.

Author publications, respond to medical inquiries, and equip MSLs with current, MLR-cleared evidence — with citations to source.

Measured Outcomes

What Life Sciences teams gain

Time to submit
-40%
Before AIWith Asteri
Triage & escalation time
-60%
Before AIWith Asteri
Capacity reclaimed
+0%
With Asteri