Causal RWE methodology, packaged.
For RWE methodology leads at academic medical centers, CROs, and pharma RWE groups. Five-method causal sensitivity pentagon as a single API call — AIPW, doubly-robust ATT, instrumental variable, neural counterfactual, Rosenbaum bounds — with reproducibility certificate and target-trial-emulation scaffolding on every study. Replaces the hand-rolled methodologist work behind every observational pharma submission.
RWE sensitivity analysis is hand-rolled, weeks-long, and rarely reproducible.
Every observational pharma study has the same chokepoint: the methodologist.
The lead biostatistician writes the propensity model in SAS, the doubly-robust adjustment in R, the instrumental-variable check in Stata, and the sensitivity analysis as a footnote — if at all. The reviewer at the FDA reads four scripts in three languages with no cross-validation between methods. The reproducibility certificate is a hash in a SharePoint folder.
"A plan for robustness assessments including deterministic sensitivity analyses, quantitative bias analyses, and net bias evaluation." — PRINCIPLED process guide, Desai, Wang et al., BMJ 2024;384:e076460.
Rosenbound delivers five methods on the same cohort, on the same platform, with the same audit ledger. The methodologist defines the cohort and treatment contrast; the platform runs AIPW, DR-ATT, IV-LATE, the neural counterfactual estimator, and the Rosenbaum-Γ bound. The reproducibility certificate is generated on submit.
The pentagon, the cohort DSL, the reproducibility certificate.
Each feature is in production today. Try the full RWE workflow on a synthetic cohort at rosenbound.ai.
Five-method sensitivity pentagon
AIPW (Robins 1994 + Bang-Robins 2005), DR-ATT with Crump-2009 overlap trim (Hahn 1998), IV-LATE 2SLS with per-prescriber instrument, neural counterfactual estimator (patent-pending), Rosenbaum 2002 Γ-bound. One submit; five estimates with covariate balance per method.
Cohort definition DSL
YAML-formatted cohort spec: treatment_value, control_value, outcome_definition, time_windows, index_date, inclusion/exclusion. CSV upload auto-generates a draft DSL; methodologist refines. Version-controlled per study.
Reproducibility certificate
Per study: cohort definition hash, cohort data hash, certificate ID, git commit of the platform version, and pinned library versions for every method. The exact re-derivation guarantee regulators ask for, in the UI — not in a SharePoint folder.
Target-trial-emulation scaffolding
Studies protocol-type for Hernán-style target trials: eligibility, treatment strategies, assignment, time-zero, outcome, causal contrast, analysis plan. Explicit guards against immortal-time bias. Aligned with the TARGET reporting statement (Cashin, Hansford, Hernán et al., JAMA 2025).
Interactive Γ-slider
On every study result: drag the Γ slider, see the bound envelope update in real time, watch the crossing-at-zero point shift. The verdict ("at Γ = 1.06, very sensitive") is generated, not narrated.
Per-method drill-down
Each of the five estimators carries its own page: covariate balance table, feature attribution, propensity distribution, instrument F-statistic for IV-LATE, Γ-curve for Rosenbaum. Where a method doesn't produce a metric, we say so — not fabricate it.
OMOP CDM v5.4 ingestion (roadmap)
Read OMOP CDM v5.4 standard tables (PERSON, CONDITION_OCCURRENCE, DRUG_EXPOSURE, MEASUREMENT, OBSERVATION_PERIOD), resolve standard concept_ids against an Athena vocabulary load, auto-populate the Cohort DSL. ATLAS cohort import (JSON/SQL via OHDSI WebAPI) in the same release window. Phase-2 deliverable.
Methodology PDF export
One-click submission package: reproducibility certificate + methodology section + sensitivity pentagon figures + hash-chained audit trail, formatted to TRIPOD+AI (Collins et al., BMJ 2024) and the FDA 7-step AI credibility framework.
Try a synthetic observational study at rosenbound.ai
Upload a cohort, define the contrast, submit. Watch all five methods compute. Drag the Γ-curve. Download the reproducibility certificate. No login, no setup. rosenbound.ai →
Aligned with the four guidances that shape RWE submissions.
✓ FDA RWE Framework (final 2023)
The FDA RWE Framework (final guidance Aug 31, 2023) directly motivates the five-method pentagon + sensitivity bound as the right shape for an observational submission.
✓ EHR / Medical Claims Data Guidance (final 2024)
Data-quality, traceability, and provenance expectations from the Jul 25, 2024 final guidance map directly onto Rosenbound's Cognitive Validation Report, cohort hash, and audit ledger.
✓ Non-Interventional Studies Draft (March 2024)
"Identifying and addressing the presence of confounding and other forms of bias is critical… planned sensitivity analyses." Cited verbatim because that's what the Γ-bound is.
✓ PRINCIPLED + TARGET reporting
FDA Sentinel Innovation Center's PRINCIPLED process (BMJ 2024) + the TARGET reporting statement for target-trial emulation (JAMA 2025) both shape the studies-protocol UX and the methodology PDF export format.
Watch the platform walkthrough at rosenbound.ai — three moments: the Cognitive Validation Report refusing incoherent data, the live Γ-bound sensitivity visualization, and the reproducibility certificate generated on every study. The full platform is open to Design Partners.
pip install rosenbound
— Official Python SDK for programmatic access: cohort upload, sensitivity-bounded study runs, and reproducibility certificate retrieval. Apache 2.0; Pydantic v2 typed; py.typed for IDE autocomplete + mypy. Platform access gated by Bearer token + RBAC + tenant scoping — the SDK is open, the audit substrate is not.
A Design Partnership for RWE methodology groups.
Rosenbound is selecting a small number of design partners across pharma drug-safety teams, CRO methodology groups, and academic RWE units. A Design Partnership costs nothing and moves no data: the platform provides production-shape synthetic cohorts; your team runs the full workflow — intake, pentagon, Γ-bounds, sign-off, certificate — in the live environment and tells us where it falls short of what a regulator would accept.