The Phanero Pilot Program
Validation Velocity. Unblock Your AI Backlog.
A structured, fixed-scope engagement to validate the intended use of your first GxP-AI model, identifying any unintended risks to the patient.
Move from "Technical Pilot" purgatory to AI safety with a repeatable validation framework with audit-ready proof.
The Pilot Deliverables
01
Effort vs. Risk Assessment
Initial assessment to qualify the effort required versus the potential risk and business returns. We qualify if the model is ready for the GxP journey.
02
Technical Model Validation
Rigorous validation assessment of technical model metrics, incorporating data either provided by your vendor or generated via internal tools and mapping them to business impact.
03
Model Risk Assessment
A deep-dive analysis to inform and categorize the specific model risk profile, adhering to CSA (Computer Software Assurance) principles.
04
The Master Validation Plan
A comprehensive plan capturing the Context of Use, Model Risk and Credibility Assessment, which gives you the playbook for our repeatable validation framework. We design the protocol to evaluate the Human+AI Team against the Human-only baseline as expected by the FDA.
05
Go/No-Go Evaluation Criteria
Definition of evaluation metrics and success criteria. We provide the binary logic required to determine a definitive Go/No-Go decision on the evaluation.
06
Phanero access
Gain access during the pilot to the system that outlines where each model is in the framework, so you can manage AI model audit readiness at scale.
Is the Validation Velocity pilot for you?
You are a Quality Director or CIO in a Top 500 Pharma/Biotech.
You have a GxP-AI model project stalled by compliance uncertainty.
Your organization has a AI mandate for 2026
You need to validate a specific high-value workflow (e.g., Clinical Reporting, Manufacturing).
Ready to accelerate your AI adoption?
Secure your slot for a Q1/2 Validation Velocity Pilot.
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