Services — Purposa Health

Our services

Three tiers. One firm that understands both the science and the compliance obligation.

Every engagement begins with a conversation. We meet you where your AI risk lives.

TIER 1 — DIAGNOSTIC

AI Bias Audit

A structured, end-to-end audit of every AI tool in your drug development pipeline. We assess training data representativeness, identify demographic performance gaps across patient subgroups, and map every finding against FDA 2025 AI guidance and EU AI Act high-risk requirements. You receive a complete, Board-ready deliverable suite.

WHAT YOU RECEIVE

→Equity Performance Scorecard™ — demographic subgroup gap analysis
→Regulatory Readiness Report — FDA and EU AI Act gap assessment
→Data Representativeness Map — training data vs. real-world patient population
→Prioritized Remediation Roadmap — ranked by regulatory and patient impact
→Executive Brief — Board and Leadership-ready summary

Engagement length: 6–14 weeks

Investment: Starting at $75,000

(Single tool audit to full portfolio audit)

TIER 2 — ADVISORY

Remediation & Design Advisory

Once bias is identified, the harder work begins. Purposa Health provides embedded advisory support to remediate identified gaps, redesign AI development processes for equity by default, and align your AI governance with Diversity Action Plan commitments and regulatory standards. Typically follows a Tier 1 audit.

WHAT WE DO

→Dataset diversity gap remediation strategy
→Equity-first AI design principles workshop
→Subgroup validation protocol development
→Regulatory submission narrative support
→AI vendor procurement standards development

Engagement length: 3–9 months

Investment: Monthly retainer from $25,000/month

TIER 3 — RETAINED

AI Integrity Governance

For organizations that want ongoing assurance that their AI tools continue to perform equitably as models evolve and patient populations shift. Purposa Health serves as your retained AI integrity partner — monitoring, reporting, and governing clinical AI performance across the full development lifecycle.

WHAT IS INCLUDED

→Fractional Chief AI Integrity Officer
→Quarterly AI Equity Performance Reviews
→AI Vendor Certification Program
→Board and Leadership AI Briefings
→Regulatory Submission AI Equity Packages

Engagement length: Annual retainer

Investment: From $180,000 annually

Our approach

Advisory with a sense of purpose.

We combine 25+ years of pharma executive operating experience with deep AI fluency and regulatory expertise — because the firms that only know data science have never run a global clinical operation, and the firms that know pharma have not kept pace with AI bias risk. Every engagement follows the Purposa Health Audit Framework™ — a structured, five-phase proprietary methodology designed to find what others miss and document it in a form regulators can rely on.

Data architecture and AI analytics dashboards used to validate drug development models

01
Discover your AI risk
A confidential 30-minute conversation to map your AI landscape, regulatory exposure, and most urgent compliance gaps. No commitment required.
02
Audit and validate
Our proprietary Purposa Health Audit Framework™ assesses every AI tool against training data demographics, subgroup performance, and FDA and EU regulatory standards across five structured phases.
03
Remediate and govern
We stay with you through remediation, regulatory submission, or ongoing AI integrity governance — as deep as your needs require and as long as the risk demands.

Who we serve

We work with leaders who are asking the hard questions.

Pharma and biotech leaders in discussion around AI integrity

Chief Digital Officers

Deploying AI tools fast and need independent validation before EU AI Act deadlines hit.

Chief Medical Officers

Patient advocacy partners are questioning whether your AI reflects the patients your drug is designed to treat.

Regulatory Affairs Leaders

An IND or NDA submission includes AI-assisted analysis. You need a defensible equity validation narrative before it goes to FDA.

VP and SVP R&D Operations

FDA has asked about subgroup performance in your AI models. You need an expert answer — fast.

Head of Clinical Operations

Your Diversity Action Plan covers enrollment. Your AI tools are not in it yet. There is a gap regulators will find.

General Counsel and Legal

The EU AI Act high-risk compliance deadline is August 2026. You need documented evidence of bias assessment now.

The mandate

The regulatory landscape is taking shape. Now is the time to assess.

FDA 2025 AI Guidance

AI tools used in drug development must demonstrate subgroup performance across demographic populations. Sponsors are accountable for the tools they deploy — not just the data they generate.

EU AI Act — August 2026

High-risk AI systems including those used in clinical decision support require bias audits, transparency documentation, and ongoing performance monitoring. Full enforcement begins August 2026.

Diversity Action Plans

FDA Diversity Action Plan requirements for clinical trials create an explicit linkage to AI tools that drive enrollment, patient matching, and protocol design. Most sponsors have not closed this gap yet.