Architecting Clinical Equity

The $8M/Day Non-Compliance Problem

FDORA mandates are non-negotiable. We automate compliance to protect your blockbuster ROI.

The DAPORT Engine

Eliminating the $1B Regulatory Wall through mathematically defensible automation.

Modules

A unified blueprint designed for the rigorous demands of enterprise clinical operations.

Governance Dashboard

Real-time oversight for complex trial portfolios and compliance tracking.

Trial Risks and Diversity Audit

Deep-learning powered audits to ensure mathematical defensibility of diversity data.

Automated generation of FDA-compliant Diversity Action Plans for Pharma.

DAP Generator

Users of DAPORT

Biotech and Pharma

For Top-20 Pharma and emerging biotechs, DAPORT serves as the ultimate regulatory insurance policy. By replacing manual guesswork with forward-looking epidemiological math, sponsors can automatically generate a 22-part, FDA-compliant Diversity Action Plan (DAP) in under 60 minutes.

DAPORT ensures pivotal Phase 3 trials launch on time, eliminating the risk of Refusals to File (RTFs) or End-of-Phase 2 clinical holds that can cost between $600,000 and $8 million per day in operational burn and lost revenue.

CROs and Regulatory

Hospitals and Academia

Med Device and Diagnostics

For Tier-1 CROs and elite FDA-focused legal firms, DAPORT is a decisive operational advantage. CROs can leverage our Trial Diversity Audit to mathematically guarantee demographic compliance during site selection, bypassing the flawed reliance on biased historical claims data.

Regulatory counsel and legal teams can utilize the DAP Generator to provide their sponsors with bulletproof, data-driven regulatory submissions that defend against costly FDA interventions and forced post-marketing rescue studies.

For leading clinical research institutions and academic medical centers, DAPORT provides the demographic intelligence needed to attract high-value enterprise trials.

By utilizing our real-time diversity and geographical site cluster analysis, hospitals can mathematically validate their access to specific, underrepresented patient populations. This allows academic sites to position themselves as indispensable, math-proof partners for pharmaceutical sponsors executing strict FDORA-mandated protocols.

As the FDA expands diversity requirements across the entire clinical landscape, medical device and diagnostic innovators must also prove their technologies work across representative demographics.

DAPORT allows these organizations to instantly assess trial risk, optimize geographical site selection to capture missing demographic data, and auto-generate compliant regulatory architecture. This ensures their clinical data is universally accepted on the first submission, protecting Go-To-Market timelines from unexpected regulatory roadblocks.

The Augmentios Difference

For Top-20 Pharma companies and Tier-1 CROs, failing the FDA's strict FDORA diversity mandate can trigger an End-of-Phase 2 clinical hold costing between $600,000 and $8 million per day. While legacy competitors frantically defend the status quo by selling open-ended consulting hours, biased historical claims data, and expensive mid-trial rescue services like decentralized home nurses, Augmentios provides absolute mathematical certainty.

Led by over 30 years of elite, blockbuster clinical leadership, our platform is a "Done-For-You" regulatory engine that utilizes forward-looking FDA census epidemiology to auto-generate a flawless, 22-part Diversity Action Plan (DAP) in just 30 to 60 minutes. We don't just monitor your diversity failure—we mathematically eliminate your regulatory risk before the trial even begins