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AI-native CRO for clinical trial operations
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.
Harbor is an AI-native eClinical data management platform designed to automate protocol-to-EDC builds, enable remote monitoring, and ensure 21 CFR Part 11/ HIPAA compliant clinical trial data management. It emphasizes AI-assisted CRF/source document generation, automated data capture, and risk-based monitoring to accelerate trial workflows.
Harbor automates study data collection by parsing protocol PDFs to generate CRFs and source documents via its Magic Build engine, uploads source documents, and uses AI to extract data directly into the EDC, reducing manual data entry. It enables real-time data visibility with zero latency and supports remote monitoring through side-by-side viewing of source documents and EDC data, with confidence scores for extraction and clinical relevance. The platform enforces compliance with immutable audit trails, eSignatures, role-based access, 21 CFR Part 11, HIPAA, and GDPR, offers validation packages, and provides an infrastructure with encryption, multi-zone resilience, and zero data retention beyond trial use. Included tools (Magic Build, Magic Capture, Magic Monitor) cover protocol-to-CRF automation, AI-assisted source data entry, and risk-based monitoring, plus ePROs and unlimited storage for source documents.
Who it’s for: Pharmaceutical sponsors, CROs, academic/non-profit research groups running clinical trials across phases
Website highlights product traction stories from multiple customers, mentions fully validated EDC in days and references to CROs/sponsors; pricing tiers and enterprise/CRO discussions imply market traction
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.
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.
How Harbor’s pitch changed across its YC launches — the in-source evolution signal.
We're building the AI operating system for clinical trials, starting with a best-in-class system of record that automates the transformation of source data into an FDA-ready package.
Harbor provides an electronic data capture system that automates clinical trial data collection and management. The platform uses AI to generate trial databases from protocols, automate data entry from source documents, and prepare FDA-ready datasets.
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We're building the AI-native CRO for clinical trials, taking on the $82B outsourced clinical trial services industry.
Harbor expanded from clinical trial software to provide full-service contract research organization services. The company automates data management, site coordination, and regulatory tasks traditionally handled manually in the $82 billion CRO industry.
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How Harbor’s homepage introduced itself over the years — each line is the page title the web actually saw, linked to that moment’s archived capture.
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