Verified biotech reasoning — priced for the teams that actually use it.
Quandra v8 is a research-mode reasoning assistant with deterministic math, citation grounding, and a five-channel verifier tribunal. It is not a medical device and does not make clinical decisions.
PRE-LAUNCH · 47 DAYS OUT
First 250 reservations lock 40% off for life.
Every reservation after that still locks 10% off for life. No card, non-binding. Launches October 31, 2026.
PK/PD calculations with unit-parser and cross-CAS verification
Protocol and SAP drafting for human statistician review
Citation grounding against 21 CFR, ICH, FDA guidance corpus
PHI firewall on all inputs (blocks MRN, insurance IDs, subscriber numbers)
Tamper-evident audit trail with e-signature sign-off
R / SAS code generation for reproducible analysis
Explicitly out of scope
Clinical decision-making for individual patients (not a medical device)
Diagnosis, treatment, or dosing of any real patient
Auto-approved regulatory submissions (all outputs require human review)
FDA-cleared software (not 510(k), not De Novo, not PMA)
HIPAA-covered PHI processing (system refuses; use de-identified data)
Substitute for a licensed biostatistician on GxP filings
Public developer API (enterprise-only, contact sales)
Guarantees of correctness — verification reduces risk, not eliminates it
Frequently asked
Is Quandra v8 an FDA-cleared medical device?
No. Quandra v8 is a research-mode reasoning tool for scientists. It is not 510(k)-cleared, not De Novo, not PMA-approved, and must not be used for individual patient decisions.
Can I use Quandra v8 on real patient data?
No. The PHI firewall blocks common PHI patterns (MRN, insurance IDs, subscriber numbers) and the system will refuse. Use de-identified data only. HIPAA BAAs are available on Enterprise plans.
How accurate is it?
On our public 60-question Reality Check benchmark, Quandra v8 leads on Robust Score and Lives-at-Risk vs. frontier LLMs. See /benchmark for live results. No system is 100% correct — every output requires human review before use.
Do you offer refunds?
Monthly subscriptions can be canceled anytime and take effect at end of billing period. No pro-rated refunds. Annual plans have a 14-day money-back window.
Can I self-host?
Yes, on Enterprise. Docker and Helm packages ship with the platform. Contact sales for the self-host license and BAA.