Accelerating Approval through Deterministic Evidence

Replace traditional, high-cost placebo groups with high-fidelity Synthetic Control Arms.  By Structuring at the Source, RegenMed provides the regulatory-ready Ground Truth required to meet the highest standards of statistical rigor — reducing trial duration and eliminating 
the "Trial Sustainability" bottleneck.
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The Breaking Point of Traditional R&D

The Problem: The "Sustainability Test" in modern medicine is nowhere more evident than in clinical development. Rising per-patient costs, recruitment delays, and the ethical complexity of placebo-controlled groups in terminal or rare conditions have created a breaking point for innovation.
The Failure of Secondary Data: Most attempts to build Synthetic Control Arms today rely on "Data Exhaust" — secondary datasets built from billing codes and messy electronic notes.  Because this data requires significant "inference" to determine clinical outcomes, it often fails to meet the strict verification standards required for FDA regulatory adjudication.

Verified at the Source: The New Rail for RWE

The Mechanism: RegenMed eliminates the "Inference Gap" by defining the data structure before the patient encounter begins.  Our Schema-on-Capture infrastructure enables clinicians to "mint" Ground Truth that is:
Deterministic
Verifiable back to the primary clinical observation, eliminating the "guessing" inherent in legacy RWE.
Longitudinal
Built on federated architecture that tracks the total patient journey across the practice of medicine.
Regulatory-Ready
Designed to align with the FDA’s evolving standards for clinical veracity and "Scientific Sovereignty".

The Strategic Advantage

Regulatory Acceleration

Reduce Phase II/III timelines by utilizing validated datasets to replace or augment control groups, meeting FDA rigor for "breakthrough" designations.

Commercial De-Risking

Bridge the "Twin Sins" of healthcare by capturing the longitudinal proof of effectiveness during the trial phase — ensuring that once the FDA approves a device, the Payer has the deterministic evidence needed to authorize coverage.

Ethical Optimization

Prioritize active-treatment enrollment by reducing the number of patients required for non-interventional placebo groups.

The Standard for Value Verification

1.4m+
Structured Datapoints
75+
Active Specialty Protocols
0%
Hallucination Rate in Verification Assets
The Evidence Vault
Access the specific Synthetic Control Arm White Paper and our peer-reviewed documentation on "Outcome Adjudication for High-Cost Interventions".
Visit The Vault

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Have a specific question? Write to us at circles@rgnmed.com and we'll respond promptly with the details you need.
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