USDM’s AI Center of Excellence delivers the governance, strategy, validation, and managed services infrastructure that life sciences organizations need to adopt AI compliantly — from first pilot to enterprise scale. We are the only partner that governs AI AND builds it within GxP guardrails.
Three structured entry points — each designed to deliver immediate, measurable value while building toward a comprehensive AI governance posture. All engagements are scoped to your regulatory context and organizational maturity.
ENTRY POINT A
AI Readiness Assessment
Structured 2–6 week assessment across USDM’s six AI maturity dimensions. Interviews, system inventory, gap analysis, and a prioritized 90-day roadmap — delivered as an executive briefing, board-ready and actionable from day one.
Six-dimension maturity scorecard with peer benchmarks
AI system inventory & shadow AI discovery
Regulatory gap analysis (FDA + EU AI Act + ISO 42001)
Prioritized use case pipeline with ROI estimates
Typical engagement
Fixed-fee
Low risk entry
Executive output
Roadmap included
ENTRY POINT B
AI Governance Foundation
Build the compliance infrastructure your AI portfolio requires. USDM develops the TRUST-AI governance framework, SOP suite, risk classification system, and governance committee charter — fully audit-ready and aligned to FDA, EU AI Act, and GAMP 5.
AI governance policy suite (12+ documents)
AI risk classification framework & RACI
Governance committee charter & operating model
EU AI Act conformity assessment preparation
Audit-ready
EU AI Act aligned
SOP deliverables
ENTRY POINT C
AI Governance as a Service (AIGaaS)
Ongoing embedded AI governance — vendor assessments, TPRM monitoring, policy maintenance, regulatory horizon scanning, and AI risk committee support. Scales with your portfolio without requiring internal FTE investment.
Embedded AI governance officer function
Continuous TPRM monitoring & vendor qualification
Quarterly board reporting & regulatory updates
AI incident management & escalation protocols
Typical engagement
Subscription
Continuous
Scalable
TPRM included
Suggested First-90-Days Engagement Arc
Week 1
Discovery & Alignment
60-minute executive alignment call — current AI landscape, regulatory exposure, priority pain points, and organizational readiness. No commitment required. USDM scopes a fixed-fee assessment proposal within 5 business days.
Weeks 2–5
AI Maturity Assessment Execution
Structured stakeholder interviews, AI system inventory (including shadow AI discovery), gap analysis against FDA CSA + EU AI Act + ISO 42001, and use case scoring across six maturity dimensions.
Week 6
Executive Findings Presentation
Board-ready briefing: maturity scorecard, risk exposure summary, prioritized use case pipeline, and 12-month governance roadmap with resource and investment estimates.
Weeks 7+
Governance Foundation or AGaaS Launch
Based on findings, initiate either the structured Governance Foundation build-out or transition directly to AI Governance as a Service for ongoing compliance management. Both include PoC delivery for top-priority use cases.
Schedule your AI Strategy Discovery Session
30 minutes. No commitment. Executive-level conversation about your AI governance posture and the fastest path to compliant adoption.
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