Harbor

AI system-of-record for clinical trial data

AI-native CRO for clinical trial operations

Harbor is a new, AI-enabled system of record for clinical trial data that replaces legacy electronic data capture (EDC) systems. Today, medical device and pharma companies spend months setting up custom EDCs that research sites then spend hours per subject per day entering data into. With Harbor, the EDC is spun up simply by reading your clinical trial protocol and research sites upload raw source documents into the platform, skipping the tedious and error-prone data entry process altogether. EDCs haven’t fundamentally changed since the 1990s. They are passive, regulatory compliant data bins that cause massive trial delays, coordinator burnout, and weeks of back-and-forth to resolve data errors. Because of this, data management currently consumes ~30% of total clinical trial budgets. With LLM and document extraction capabilities finally reaching the accuracy, reliability, and traceability required in high-risk domains, Harbor is redefining the way data is collected and monitored in clinical trials, all while remaining fully GCP- and 21 CFR Part 11 compliant. After months of building our initial product, our platform is now live with its first few clinical studies. For our largest customer and their 1600 subject randomized trial, we were able to use our internal tools to get their study database configured in just one week, which was ten times faster than legacy EDC vendors quoted. We built Harbor because we lived through this problem. Albert spent four years in clinical trials and regulatory strategy for a medical device startup, spending weeks at clinical sites watching coordinators battle legacy software firsthand. Nate brings the technical firepower, having built scalable software at Google and Ramp and as employee #1 at a previous YC startup.

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.