In plain English: Quantum Rx runs the clinical & regulatory pipeline end to end — trial design, patient stratification, companion diagnostics, pharmacoeconomics, FDA IND assembly — thirteen tools, five genuinely quantum. Every record sealed to 21 CFR Part 11 / HIPAA standards.
Size it wrong and you spend years to reach an inconclusive readout. The sample size is a decision you can't take back.
Without companion diagnostics and stratification, a drug that works for a subgroup fails the whole population — and the program dies.
FDA IND assembly and 21 CFR Part 11 records are unforgiving. A dossier with a gap is a clinical hold you didn't budget for.
Thirteen tools spanning T0–T3 — five run genuine quantum (QAE, QSVM, QAOA), exact statevector below the router threshold and real IBM Heron above it, with resolvable job IDs.
Power and sample-size optimization, adaptive designs and synthetic control cohorts — sized to prove what you need to prove.
Companion-diagnostics matching and patient stratification — the right drug to the right responders.
Pharmacoeconomic / QALY analysis and pharmacovigilance — value and adverse-event signal, on the same record.
Regulatory-pathway mapping and automated FDA IND dossier assembly — sealed to 21 CFR Part 11.
A working trial-design tool. Enter your endpoint and the designer computes the sample size to power it — adjusted for dropout — places the study on the development pipeline, runs the IND-readiness checklist, and seals the design. The deterministic power calculation the QAOA path optimizes against.
QSVM companion-diagnostics matching defines the population where the drug actually works.
Closed-form power sets the sample size; QAOA optimizes the adaptive design — exact statevector or real IBM Heron.
Design, inputs and assumptions sealed Ed25519 + ML-DSA to a WORM ledger — IND-ready, 7-year retention.
d8t0s1cbp3hs7383qq4g (ibm_kingston, simulator:false, DONE) plus 13 further real jobs are catalogued. Closed-form outputs are recomputable by hand; every required-field tool rejects empty input with no invented result.Add Quantum Rx to your watsonx Orchestrate workspace, or let the Prompt Builder wire it into a stratify-size-submit chain.