Hey everyone 👋

We're Albert and Nathan from Harbor, back with a bigger vision.

TL;DR

Harbor is an AI-native contract research organization (CRO) for running clinical trials. We started as an AI-enabled system of record, and grew to seven trials and $15.6k in monthly software revenue. Now we’re expanding from clinical trial software into full-service trial execution and just signed our first seven-figure contract to run a clinical trial end-to-end for a publicly traded medical device company.

Ask: Can you introduce us to founders who might be running a clinical study soon or directors and VPs of Clinical Operations at medical device and biotech companies? Contact us at [email protected]

🤦‍♂️The Problem

Of the money spent on new drug and device development today, 45% of it is spent on clinical trials. Some of that money is spent on software and some is spent on paying clinics and study subjects. But, the biggest line items in any clinical trial budget are made up of services (60%-80%). Today's clinical research is contracted out to armies of project managers, monitors, data managers, and coordinators manually configuring forms, chasing sites, verifying source data, resolving queries, reconciling records, and preparing for and performing analysis.

🌪️ Why We're Re-Launching

When we first launched (link to post), we were building an AI-native system of record for clinical trial data – an EDC system, for those who are familiar with the space. That product is working. We now support seven trials and our software can generate trial databases from protocols, automate parts of data entry, support source data verification, and produce audit-ready clinical datasets. As one of our customers noted, our platform streamlined a “standalone, two-month project”for study start up into just “two days” of work.

With encouragement from our YC partners, we decided to aim beyond just replacing one piece of software. Since we own the system of record, why not run the full clinical trial ourselves, selling the "services" customers already buy but using our own software to automate and compress the labor.

A month ago, I hopped on a flight to Boston to try to close our first contract as a full-service contract research organization (CRO); two weeks later, we signed a seven-figure deal to run a clinical trial end-to-end for a publicly traded medical device company.

Drug and device companies are already used to outsourcing their clinical operations. That's why an $82 billion CRO market exists today. We can deliver the same regulated service customers already buy from legacy CROs, but with fewer handoffs, faster execution, and better margins.

❓ Our Ask

If you answer “yes” to any of these, we’d love your help:

• Do you know any founders of biotech, medtech, or digital health companies that might be gearing up for clinical trials? Or are you one yourself?
• Do you know any VPs or directors of clinical operations at larger pharma, biotechs, or medtechs?
• Do you know anyone who has bought from, sold to, or operated inside clinical research organizations?

👉 Contact us at [email protected]

Thank you!!

👏 The Team

Albert and Nate met seven years ago in English class at the University of Michigan ("Art of the Personal Essay").

Albert (CEO) helped run clinical trials and regulatory strategy at Biolinq, a medical device startup that received its FDA authorization last year. He literally lived at a clinical site for a month during the company's pivotal trial, keeping site staff entertained while they spent hours manually entering data. He also spent two years as an analyst for the medical device industry.

Nathan (CTO) is an ex-Google, ex-Ramp engineer who has built websites serving hundreds of thousands of visits per month and open-source projects with millions of downloads.