{"id":98843,"title":"Harbor: AI system of record for clinical trial data","tagline":"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.","body":"Hey everyone 👋\n\nWe're Albert and Nathan from Harbor.\n\n**TL;DR**\n\nHarbor 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!\n\n**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](mailto:albert@runharbor.com)\n\n\u003chttps://www.youtube.com/watch?v=mBOYEL58RWw\u003e\n\n**🤦‍♂️ The Problem**\n\nEveryone 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.\n\nClinical 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](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-based-approach-monitoring-clinical-investigations-questions-and-answers) **against** this way of doing things, it remains the de facto standard for the way clinical trials are run today.\n\nAt Harbor, we're changing that…\n\n**💡 Our Solution**\n\nAt 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.\n\n* 👷 Our \"Magic Build\" feature takes clinical trial protocols and turns them into customized EDC builds within minutes. \n* ✍️ 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.\n* 🕵️‍♀️ 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.\n\nAll 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.\n\n![uploaded image](/media/?type=post\u0026id=98843\u0026key=user_uploads/2019219/426a3a2d-c750-47bc-813c-d386c2a13f21)\n\n**🥺 Our Ask**\n\nIf you answer “yes” to any of these, we’d love your help:\n\n* 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!\n* Do you know any VPs or directors of clinical operations at larger pharma, biotechs, medtechs, or CROs?\n* Do you have experience selling software into pharma, biotech, or medtech companies?\n\n👉 Contact us at [albert@runharbor.com](mailto:albert@runharbor.com)\n\nThank you!!\n\n👏 **The Team**\n\nAlbert and Nate met seven years ago in English class at the University of Michigan (\"Art of the Personal Essay\").\n\nAlbert (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.\n\nNathan (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.","slug":"PiF-harbor-ai-system-of-record-for-clinical-trial-data","created_at":"2026-03-16T15:30:02.876Z","updated_at":"2026-05-25T03:45:50.775Z","total_vote_count":36,"url":"https://www.ycombinator.com/launches/PiF-harbor-ai-system-of-record-for-clinical-trial-data","share_image_url":"//bookface-static.ycombinator.com/assets/ycdc/yc-og-image-c440a0ad1dacfb86eeeb343717479cc54d256614449b4ef719977a0a451f8bc8.png","company":{"id":31445,"name":"Harbor","slug":"runharbor","url":"https://runharbor.com/","logo":"https://bookface-images.s3.amazonaws.com/small_logos/2035055dd5fbc0e7ba3359cc653941b651ebff6b.png","batch":"Spring 2026","industry":"Healthcare","tags":["SaaS","Health Tech","B2B","Healthcare"],"search_path":"https://bookface.ycombinator.com/company/31445"}}