A governance layer for consent, audit, and data provenance in CRISPR trials — designed for 21 CFR Part 11, ICH E6(R3), and GDPR, and built to sit alongside the Medidata and Veeva systems you already run, not replace them.
Built for trial sponsors, CROs, and authorised treatment centres running gene-editing programs — and the regulatory, clinical-ops, and security teams who have to sign off on them.
Federated intelligence is designed to score eligibility across genomic data that can't be centralised, and to design the edit — with the model governance the EU AI Act and FDA AI/ML guidance require.
From guide design through manufacturing to reinfusion, designed to keep chain of custody intact from vein to vein.
Granular consent, WORM provenance, and hash-chained audit designed for 21 CFR Part 11 — with consent withdrawal designed to propagate across the whole program within a 60-second target.
Designed so sponsors, treatment centres, patients, and regulators each see the view they need — over a single, tamper-evident record of the trial.
Eligibility depends on variant-level analysis across data that legally can't be centralised.
Editing a genome demands provenance and consent traceability that spreadsheet-era audit trails can't provide.
75+ authorised centres activated, yet roughly 40 patients infused in two years. The bottleneck is operations, not science.
Far fewer than the network implies. Two years after Casgevy became the first approved CRISPR therapy, the treatment centres exist but throughput does not:
Source: CRISPR Therapeutics Q3 2025 results. The bottleneck is operations, not science — the gap HelixChain is designed to close.
We're building it with a small group of treatment centres and sponsors running CRISPR programs. Design partners shape what we build and see it first.