FDA Fit-for-Purpose · 7-Step QCARD Framework
Oncology cohort validation
in 90 seconds, not 7 weeks
Submit external control arm packages to FDA with data you can defend. OncoSys validates your cohort against the 7-Step QCARD framework and generates a tamper-evident attestation report (audit-ready for FDA submission) — in the time it takes to make coffee.
Accepting 5 pilot partners in Q2 2026 · Epic, TCGA, or RWD data preferred
Trusted standards & data sources
FDA 7-Step RWE
ICH E6(R3)
21 CFR Part 11
TCGA · Epic · NCI
C10 Labs cohort partner
