A small team of clinical operations veterans and engineers, building the system of record we wished we'd had at our last jobs.
HVN Portal was founded in 2021 in Boston, after our co-founders met at a Phase III oncology study where the trial master file was scattered across two SharePoint sites, one shared inbox, and a Smartsheet that nobody owned. The study finished. The audit finding didn't.
We spent a year talking to clinical operations leaders at sponsors and CROs in the US, EU, and UK. The same patterns came up: TMF gaps discovered too late, site activation cycles bloated by document handoff friction, monitoring teams flying blind between visits. The tools existed, but they were built for the previous decade — heavyweight, slow to deploy, expensive to maintain.
We launched in early 2022 with a small group of design partners running Phase II studies. By 2024 our customers spanned both early-stage biotechs and mid-sized CROs. We stay deliberately small as a team, and ship every two weeks.
A handful of people, mostly remote, with a hub office in Boston.
Former Director of Clinical Operations at a top-five pharma. Ran Phase II–III oncology programs across 14 countries. PhD, regulatory affairs.
Spent eight years building enterprise software for life sciences. Led the engineering team behind a widely-used eTMF product before HVN.
Headquartered at 75 State Street, Suite 2500, Boston, MA 02109. Team members in London, Lisbon, and Toronto. We hire people who've worked in clinical operations or who care enough to learn it cold.
We design and validate against ICH-GCP E6 (R3), 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA. We're SOC 2 Type II audited annually. Compliance documentation is available under NDA — request it through your account team.