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Harbor

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AI-native CRO for clinical trial operations

Spring 2026Founded 20252 peopleSan Diego, CA, USA
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Clinical Trial OperationsServicesPharmaceutical companies, biotech, medical device firmsLow competition
Moat
Proprietary electronic data capture system and trial execution playbooks; regulatory relationships; reputation.
Key risk
Clinical operations highly regulated; long sales cycles; data/liability risks; dependence on physician networks.
Why now
CRO costs inflating; sites and patients becoming harder to recruit; AI automating manual workflows.
Competitors
PAREXEL, IQVIA, Covance, Syneos Health

About

Harbor is building an AI-native contract research organization (CRO) for clinical trials. We started with an AI-native system of record for clinical trial data (electronic data capture system), grew the software business to seven trials and ~$187k in contracted software revenue over the next twelve months, then expanded into full-service trial execution and signed our first CRO contract worth $1.93M over three years. Clinical trials consume 45% of all new drug and device development spend. While some of that goes to software, sites, and patients, the largest line items are services: project management, monitoring, data management, site coordination, source verification, query resolution, record reconciliation, and analysis. Today, drug and device companies outsource clinical operations to legacy CROs and their massive teams, which is why the CRO market is $82B annually. Harbor delivers the regulated services companies buy from legacy CROs, but built around our AI-native system of record from day one. Our software already automates the core data workflows: study build, data capture, query generation, monitoring, signing, and database lock. Because we own the system of record, we can expand into the surrounding service workflows: site contracting and billing, subject engagement and retention, statistics, reporting, and more. We built Harbor because we lived through the problem. Albert spent four years in clinical trials and regulatory strategy at a medical device startup, taking an unproven wearable from first-in-human trials to FDA authorization. Nate brings the technical depth, having built scalable software at Google and Ramp and served as employee #1 at a previous YC startup.

Founders Β· 2

Albert Cai
Albert CaiFounder
MichiganπŸŽ“ University of Michigan

Albert is the co-founder and CEO of Harbor. Before Harbor, Albert helped run clinical trials and regulatory strategy at Biolinq, helping take the company's first and flagship product from prototype through its first human studies and eventual FDA De Novo authorization. Prior to Biolinq, Albert led diabetes technology coverage at Close Concerns, a boutique consulting firm. Albert studied biomedical engineering at the University of Michigan.

Nathan Leung
Nathan LeungFounder
GoogleUCLAMichiganπŸŽ“ University of Michigan

Nate is the co-founder and CTO of Harbor. He spent the last five years working at tech companies ranging from seed-stage startups to Ramp and Google. He’s built zero-to-one systems as the first employee of another YC startup and wrote smart contracts securing millions in assets at a blockchain infrastructure company. He studied pure math at UCLA and computer science at the University of Michigan.

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