Healthcare software · Clinical trial operations
Harbor
A two year old, two founder company building an AI-native electronic data capture system for clinical trials, now expanding into running the trials themselves as a contract research organization.
A flight to Boston
A month before Harbor relaunched publicly on Y Combinator’s site in 2026, its CEO got on a plane. “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,” Albert Cai wrote in the company’s Launch YC post. Harbor has not named that customer.
That trip marked a pivot. Harbor started as software: an electronic data capture system, the database clinical trial sponsors use to collect and store patient data. By the relaunch it said it was live in seven trials with about $15,600 in monthly software revenue, roughly $187,000 on an annualized basis. The Boston contract pushed Harbor into a different business: running trials as a contract research organization, the role legacy firms like IQVIA and Parexel occupy today.
The problem with digital paper
Clinical trials eat up 45% of new drug and device development spending, according to Harbor’s own account of the market. Of that, the company says 60% to 80% goes to services rather than software or patient payments: project managers, monitors, and coordinators who configure forms, chase sites, verify source data by hand, resolve queries, and reconcile records.
Harbor’s pitch is that the software underneath that work, the EDC, has not meaningfully changed since the early 2000s. “Today’s multi-billion dollar EDC market is full of digital file cabinets, software that can store data but is blind to the quality of its contents,” the company says on its website. Its own system, it says, speeds up data entry tenfold and supports fully remote monitoring, so trial monitors do not have to fly to a site to compare paper source documents against what was typed into the database.
Because Harbor owns that system of record, it argues it can expand into the service work around it: site contracting and billing, subject engagement, statistics, and reporting, the line items that make up the $82 billion CRO market it now wants a piece of.
Founders
Albert Cai and Nathan Leung met in an English class, “Art of the Personal Essay,” at the University of Michigan seven years before founding Harbor, according to the company’s Launch YC posts. Cai studied biomedical engineering there and, per Harbor’s own company page, turned down medical school to instead work in clinical, regulatory, and product roles at Biolinq, a San Diego wearable biosensor company, taking its flagship product from first-in-human testing through FDA authorization. Before Biolinq, Cai led diabetes technology coverage at Close Concerns, according to Harbor’s own YC profile and the YC Tier List’s independent writeup.
Biolinq’s FDA authorization is independently documented: it won De Novo classification for its Shine wearable biosensor on September 25, 2025, according to trade outlet MassDevice, which described Biolinq as San Diego based and closing a $100 million Series C earlier that year. That is independent confirmation of the kind of device authorization work Harbor’s materials say Cai was part of.
Leung, Harbor’s CTO, is described in the company’s Launch YC posts as an ex-Google, ex-Ramp engineer who was employee number one at a previous YC startup and studied pure math at UCLA and computer science at Michigan. Harbor’s own blog credits “modern software development methodologies pioneered by companies like Google, where my co-founder previously worked as a software engineer,” as an influence on how the product is built.
From EDC to full CRO, in eight months
Harbor first launched on Y Combinator in 2025 pitching itself as “the AI operating system for clinical trials, starting with a best-in-class system of record.” At that point it said it was live in five clinical studies and had built a 21 CFR Part 11 compliant EDC in eight months. Its two flagship features, “Magic Build” and “Magic Capture,” turn a trial protocol into a configured database and let sites upload paper or electronic source documents for the software to transcribe automatically.
By the 2026 relaunch, the company said one customer had described Harbor’s platform as turning a two-month startup project into two days of work. That customer was not named either.
The Boston contract, Harbor’s first as a full-service CRO, is where it now says its growth will come from. Whether a two-person software team can also run the regulated, service-heavy work of a contract research organization, historically staffed by large, distributed teams of monitors and coordinators, is the open question 2026 and 2027 should start to answer.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Founding and batch | Founded 2025. Y Combinator lists Harbor in its Spring 2026 batch, with primary partner Nicolas Dessaigne, a team size of three, and status Active. | Accelerator record |
| Location | Y Combinator and aggregator LaunchMeLoud both list San Francisco. Harbor’s own careers page says its team is based in San Diego. PitchBook lists a Dover, Delaware corporate address, typical for a registered agent rather than an office. | Conflicting |
| Headcount | Y Combinator’s company profile lists a team size of three. PitchBook lists two employees. | Conflicting |
| Software revenue | Company says seven trials live on its EDC and about $15,600 in monthly software revenue, described elsewhere in the same posts as roughly $187,000 in contracted software revenue on a twelve month basis. No independent revenue figures were found. | Company-stated |
| First CRO contract | Company says it signed a $1.93 million, three year contract to run a clinical trial end to end for a publicly traded medical device company. The customer is not named, and no independent confirmation was found. | Not independently confirmed |
| Regulatory compliance claims | Company says its platform meets 21 CFR Part 11 and Good Clinical Practice requirements and provides customers a validation package. No FDA finding or third party audit of Harbor itself was found; the FDA regulates trial sponsors, not EDC vendors directly. | Company-stated |
| Founder background at Biolinq | Biolinq, a San Diego wearable biosensor maker, received FDA De Novo classification for its Shine sensor on September 25, 2025, and had closed a $100 million Series C earlier in 2025, according to trade press. This corroborates the kind of device authorization work Harbor’s materials say its CEO was part of, though it does not confirm his specific role or dates. | Independent |
| Outside capital | PitchBook lists two deals: an accelerator investment around January 2026 and an early stage venture round around September 1, 2026 with Core Innovation Capital, $500,000 raised to date, individual amounts undisclosed. No SEC Form D under a Harbor entity was found in EDGAR as of September 25, 2026. | Public record gap |
Read plainly: the product story, an EDC that moved from a handful of studies into a large services contract, is told consistently across Harbor’s own posts and Y Combinator’s directory. Missing is independent confirmation of the numbers that matter most: revenue, the seven-figure customer’s identity, and a filing showing how much capital has come in and from whom.
What to watch
- Whether Harbor names the publicly traded medical device company behind its first CRO contract.
- Whether a Form D or other SEC filing appears as Harbor raises a larger round.
- Whether the company settles its own conflicting location and headcount claims.
- Whether Harbor can staff and deliver full CRO services, a labor intensive business, with a two or three person team.
In their words
“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.”
Albert Cai, co-founder and CEO, Launch YC relaunch post, 2026 · Company post
“Today’s multi-billion dollar EDC market is full of digital file cabinets, software that can store data but is blind to the quality of its contents.”
Harbor company website, accessed September 25, 2026 · Company-stated
our platform streamlined a “standalone, two-month project”for study start up into just “two days” of work.
Unnamed customer, quoted in Harbor’s Launch YC relaunch post, 2026 · Customer quote, company-published
“Albert and Nate met seven years ago in English class at the University of Michigan (‘Art of the Personal Essay’).”
Harbor, Launch YC posts, 2025 and 2026 · Company-stated
“A domain expert who lived the pain (Albert’s 4 years at Biolinq, including FDA authorization experience) paired with a technical founder who’s shipped at scale (Google, Ramp, YC).”
The YC Tier List, independent writeup of Harbor’s Spring 2026 batch entry · Independent
“Our team is based in sunny San Diego, California. We’re minutes from the ocean and work right next to some of the most innovative medtech and biotech companies in the world.”
Harbor careers page, accessed September 25, 2026 · Company-stated
“The entire Biolinq team is thrilled about this regulatory milestone, which is a testament to the outstanding work by our team.”
Rich Yang, CEO of Biolinq, on the company’s FDA De Novo classification, MassDevice, September 25, 2025 · Independent
Related companies
Sources
- CompanyHarbor: AI-native CRO for clinical trial operations
- CompanyLaunch YC: Harbor, AI-native CRO for clinical trial operations
- CompanyLaunch YC: Harbor, AI system of record for clinical trial data
- CompanyHarbor homepage
- CompanyHarbor company and careers page
- CompanyCompliance Without Compromise: How Harbor Ships Fast and Stays Constantly Validated
- IndependentHarbor, AI system-of-record for clinical trial data
- IndependentHarbor (Discovery Tools (Healthcare)) company profile
- IndependentHarbor company listing
- IndependentBiolinq wins FDA de novo nod for autonomous, needle-free CGM
- Public recordSEC EDGAR company search, Form D filings matching “Harbor”
- CompanyHarbor company profile
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
