Open to Strategic Conversations

We Built the Screening Tool Clinical Sites Actually Need.

Sapion Health is a HIPAA-compliant clinical research intelligence platform. We're looking for the right partner to help us scale — whether that's through acquisition, investment, or strategic collaboration.

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Straight talk

Here's Where We Are

No inflated numbers. No vanity metrics. Just the facts.

What We've Built

AI-powered protocol extraction — upload a PDF, get structured criteria, visits, and activities in seconds
21 CFR Part 11 compliant from day one — audit trails, e-signatures, form hashing
HIPAA-ready infrastructure — encrypted email, row-level security, secure auth
Document Hub — centralized document management with auto-type detection and cloud sync (OneDrive)
eConsent tracking — document extraction, version management, and compliance workflow
Study management, protocol categorization, visit scheduling, team roles, AI copilot, PDF export
Working beta with active research sites

Why It Matters

→Most research sites still screen patients with paper binders and spreadsheets
→Screen failures are expensive — sites eat the cost of wasted time and resources
→FDA is increasingly enforcing electronic records requirements
→No dominant player exists — the market is fragmented and underserved
→LLMs finally make real-time protocol analysis viable

Differentiation

What Makes This Different

Built by people who understand clinical trials. Not a horizontal SaaS adapted for healthcare.

Compliance-First

21 CFR Part 11 isn't a checkbox — it's in the architecture. Audit trails, e-signatures, session timeouts, form state hashing.

AI That Actually Works

Upload a protocol PDF. Get structured criteria, visit schedules, and activities extracted automatically.

HIPAA-Ready

Encrypted email, row-level database security, secure auth flows. Not an afterthought.

Built for Research Teams

Coordinators screen, investigators review, PIs sign off. Role-based access that matches how sites actually work.

Capital-Efficient

Serverless infrastructure. Near-zero marginal cost per site. No bloated sales org — the product sells itself.

Network Effects

Every protocol uploaded makes the system smarter. Sites share protocols. Growth compounds organically.

Pathways

What We're Looking For

We're open to the right fit. Here are the conversations we're having.

Acquisition

·Full platform — IP, codebase, team, customer relationships
·Production-ready 21 CFR Part 11 compliance architecture
·Immediate entry into clinical trial technology
·Clean cap table, standard documentation

Investment

·Pre-seed / seed to accelerate go-to-market
·Healthcare-focused investors preferred
·Capital for sales, SOC 2 certification, enterprise features
·Board or observer seat available

Strategic Partnership

·Integration with CTMS, EDC, or site workflow platforms
·Co-development for mutual customer base
·Joint go-to-market with complementary technology
·CRO and site network distribution

Technology Partnership

·API and integration partnerships
·White-label or embedded screening
·Document and workflow connector development
·AI model collaboration

Channel Partnership

·Reseller or referral agreements
·Geographic expansion
·Training and implementation
·Site network distribution

Get in Touch

Let's Talk

Serious inquiries only. We respond within 1–2 business days.

What to Expect

We read every inquiry personally
Response within 1–2 business days
All conversations are confidential
NDA available on request

Direct Contact

Use the form to get in touch with our team.