The AI-Native Governance & Intelligence System

ANGIS — the platform that keeps your
clinical programs inspection-ready.

Continuous GCP compliance monitoring, AI governance, and inspection readiness — purpose-built for clinical trial sponsors.
We foster innovation from concept through commercialization.

Book a Conversation How It Works

The Problem

Inspection readiness is
a fire drill.
It shouldn't be.

65%
of FDA 483 observations cite documentation and procedural failures — not scientific issues. The gaps were knowable. They just weren't monitored.
90%
of sponsors manage inspection readiness manually — spreadsheets, email threads, and tribal knowledge that walks out the door with every team change.
8–12 wks
the average scramble time between an inspection announcement and the inspection itself. That's weeks of diverted clinical operations resources.

Most inspection failures aren't surprises in hindsight. The signals were available. The monitoring wasn't continuous.

01
Systems Don't Talk
EDC, CTMS, TMF, safety databases, and CRMs operate as islands. The cross-system gap that triggers a 483 finding doesn't exist in any single system — it exists between them.
02
Readiness Is Episodic, Not Continuous
Sponsors prepare for inspections when inspections are announced. By then, the gaps have been accumulating for months. Continuous monitoring catches deviations the day they happen — not the week before an inspector arrives.
03
No Institutional Memory
Every program repeats the same compliance patterns from predecessors. Without a governed record that connects findings to remediation to outcomes, lessons cannot accumulate across programs or across the organization.

Our Solution

Governed intelligence
infrastructure for
regulated biopharma.

Vendor-Independent Data Bridge
A governed integration layer that connects your EDC, CTMS, TMF, safety database, and CRM into a unified knowledge graph — without replacing any of them. Every entity link carries provenance attribution.
Continuous Compliance Monitoring
Real-time evaluation of your clinical programs against GCP, ICH E6(R3), 21 CFR Part 11, and your own SOPs. Gap findings surface proactively — not when the inspector arrives.
Governed by Design
Every output carries full provenance attribution — the data sources, the rules applied, the confidence score, and the timestamp. Your qualified personnel review and act on findings. You govern; ANGIS makes governance effortless.
Auditable Governance Records
Every finding, every remediation, every action is linked to a structured governance record — creating a searchable, inspection-ready audit trail that survives due diligence. Your team makes the calls. ANGIS ensures those calls are documented, attributed, and retrievable.

ANGIS Platform

Three tiers.
One governed platform.

Core Platform
ANGIS Core

Always inspection-ready. Continuous monitoring of your trial programs against GCP, ICH E6, and 21 CFR Part 11. Gap findings surface before the inspector arrives — not after. ANGIS Core connects to your existing clinical systems, builds a vendor-independent knowledge graph, and maintains a living readiness score per study, per site, per program.

  • GCP & ICH E6(R3) continuous monitoring
  • TMF completeness tracking
  • Protocol deviation follow-up alerts
  • Living inspection readiness score
  • Inspection readiness package on demand
Intelligence Layer
ANGIS Assist

Intelligence at the moment you need it. Real-time natural language queries over your trial data. Regulatory precedent matched to your gaps. Audit narratives drafted. ANGIS Assist is the governed reasoning layer that sits between your fragmented systems and your regulatory obligations — every answer carries provenance back to the source system and record.

  • Natural language queries across clinical systems
  • Regulatory precedent matching
  • Audit narrative generation
  • Governed retrieval with full provenance
  • Cross-system entity resolution
Aggregated Analytics
ANGIS Intelligence

See what no single sponsor can see alone. Anonymized, benchmarked analytics across departments, vendors, assets, regulators, trials, indications, programs, and sectors. ANGIS Intelligence surfaces patterns that no individual sponsor could detect from their own data — which compliance gaps are systemic, which remediation strategies work, and where the next inspection focus areas are trending.

  • Cross-program compliance benchmarking
  • Vendor performance analytics
  • Regulatory focus area trend detection
  • Portfolio governance dashboard
  • Board and executive compliance reporting
Core System Patent Pending · No. 19/459,855
200+ KOLs Engaged

The Team

Built by someone who has
lived the problem.

Gabrielle Foster
Gabrielle Foster
Founder & Chief Executive

Former Takeda R&D Clinical Operations leader. MIT-trained data scientist. Doctoral researcher in AI-enabled clinical trials. Gabrielle has designed research protocols, led regulatory inspection readiness programs, and managed clinical studies across global development programs. She built ANGIS to solve the problem she lived firsthand — where inspection readiness was always a fire drill, compliance monitoring was manual and episodic, and the institutional knowledge that could prevent repeated findings walked out the door after every program.

MIT, Johns Hopkins, Takeda, Gates Foundation, Harvard, Maveric
ORCID LinkedIn Google Scholar

Work With Us

Built for the teams who refuse
to be caught unprepared.

Whether you're a pharma sponsor managing multi-site global trials, a biotech preparing for a pre-approval inspection, a CRO building operational infrastructure for sponsors, or a clinical operations leader who's tired of fire drills — if your programs need to be inspection-ready by default, ANGIS was built for you.

Book a Conversation