Harbor: AI system-of-record for clinical trial data

Harbor

AI system-of-record for clinical trial data

Active

https://runharbor.com/

AI system-of-record for clinical trial data

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.

Active Founders

Albert Cai

Founder

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.

Albert Cai

Founder

Nathan Leung

Founder

Nathan 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.

Nathan Leung

Founder

Company Launches

Harbor: AI system of record for clinical trial data

See original launch post

Hey everyone 👋

We're Albert and Nathan from Harbor.

TL;DR

Harbor is a new system of record for data collection in clinical trials. Current systems are slow, clunky, and require hours and hours of manual labor. We're already live in five clinical studies and looking for more!

Ask: Can you introduce us to founders who might be running a clinical study soon or directors and VPs of Clinical Operations at CROs, medical device, and biotech companies? Contact us at albert@runharbor.com

https://www.youtube.com/watch?v=mBOYEL58RWw

🤦‍♂️ The Problem

Everyone knows clinical trials are slow and expensive. Most people assume it's due to subject recruitment or regulatory requirements. But, a huge part of the problem is much simpler: manual data entry.

Clinical trial data is collected through a special database called an EDC (electronic data capture). Despite the massive amounts of spend, today's EDCs have not changed since the early 2000s. Companies spend 2-3 months manually configuring their EDC for each clinical trial. Clinical sites collect data from patients in the EHR or on paper and then spend hours entering that data by hand into the company's EDC. Finally, companies hire armies of people to literally fly to each clinical site and double check the data entered into the EDC. Despite the FDA's guidance against this way of doing things, it remains the de facto standard for the way clinical trials are run today.

At Harbor, we're changing that…

💡 Our Solution

At Harbor, we've built a new EDC platform that automates the most manual and tedious processes in data management, allowing sponsors and sites to spend more time with subjects, making sure the operations are running smoothly, and ultimately getting to database lock and regulatory submission faster.

👷 Our "Magic Build" feature takes clinical trial protocols and turns them into customized EDC builds within minutes.
✍️ Our "Magic Capture" feature allows clinical sites to upload their source documents, whether electronic or paper, and Harbor enters the data into the EDC for them automatically.
🕵️‍♀️ As a result, sponsors get access to the study data in near real-time and their monitors don't have to fly all over the country just to compare what's on paper with what's in the EDC.

All of this is built into our fully validated and 21 CFR Part 11 and GCP-compliant software platform with roles, audit trails, and more, so that the data collected in Harbor can be used for regulatory submissions.

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🥺 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? Reach out, let us know you found us on Launch YC and we'll waive your set up fee!
Do you know any VPs or directors of clinical operations at larger pharma, biotechs, medtechs, or CROs?
Do you have experience selling software into pharma, biotech, or medtech companies?

👉 Contact us at albert@runharbor.com

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) has 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’s now bringing his experience building cryptographically-secure, regulated, end-to-end systems to Harbor, where we’ve launched a brand-new, 21 CFR Part 11 compliant EDC in just eight months.