Harbor (YC X26) — AI-native CRO for clinical trial operations

In their words

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.

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