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          • Internal Project Tracker: FR Quantificare Sanofi AD Clinical Trials Retrospective
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R-009-001 FR Quantificare Sanofi AD Clinical Trials 20260505

  • Deal Id: 60028458866
  • Deal name: FR Quantificare - Sanofi: AI Photo Analysis Proof of Concept Study

Project Overview​

Proof of concept retrospective analysis study to validate the ability of the device to assess Atopic Dermatitis (AD) severity via automated EASI scoring and AD diagnosis, applied to existing clinical photographs from three completed Phase 3 amlitelimab trials (COAST-1, COAST-2, SHORE). Images remain in the custody of the photography vendor at all times; the device processes images and returns coded results only.

Project Summary​

Details​

  • Desired Delivery Date: 2026-11 (TBC)
  • Duration: TBC
  • Sites: 102 (34 EFC17559, 33 EFC17560, 35 EFC17561)
  • Countries: France
  • Subjects: 123 participants
  • Diagnostic Reports: ~3,308 (AI outputs per photograph)
  • Images: ~3,308 photographs across 3 studies (858 + 989 + 1,461)
  • Trainings: 1 (results interpretation)
  • Meetings: TBC

Technical Implementation​

  • Product: JSON Only
  • Conditions: Atopic Dermatitis (AD)
  • Scoring System: EASI (Eczema Area and Severity Index)
  • Integration: AWS S3 Bucket access for secure upload of images by the photography vendor and download of coded results (JSON). The photography vendor reconciles the database and delivers consolidated coded outputs to the sponsor. No photographs are transferred to the sponsor at any point.

Scope​

In Scope:

  • Automatic Image Quality Control
  • Atopic Dermatitis (AD) Diagnosis
  • Automated EASI Scoring
    • Redness (erythema)
    • Thickness (induration/papulation)
    • Scratching (excoriation)
    • Lichenification
  • Individual AI reports per participant per visit
  • Consolidated AI scores and statistics

Out of Scope:

  • Direct image transfer to sponsor

System Architecture​

Data Flow​

Project Timeline and Milestones​

To achieve the goals, the parties agree on the following timeline.

info

Timeline dates are illustrative. Actual dates TBC upon contract execution.

Project Tasks​

🧭 Definition & Planning​

TaskDescriptionResponsibleStatus
Project conception and initiationInitial ideation and opportunity scoping with all key stakeholders.JD-002, JD-013✅ Done
Definition and planningDefine project details: scope, key deliverables, timelines, success metrics, and required resources.JD-002, JD-013🔄 In Progress
Implementation plan definedProject scope, key deliverables, timelines, success metrics, and required resources are defined and clearJD-002, JD-013🔄 In Progress

📝 Contracting​

TaskDescriptionResponsibleStatus
DTA Drafting (Photography Vendor)Photography vendor drafts the Data Transfer Agreement governing image custody and AI processing scope.JD-002⏳ Pending
Offer SentFormal offer/proposal shared with the customer for review.JD-002⏳ Pending
Offer ApprovedCustomer reviews and approves the proposed scope, terms, and pricing.⏳ Pending
Contract ReviewAlign on deliverables, timelines, legal, GDPR, and data terms.⏳ Pending
Contract SigningFinalize and sign all contractual agreements, including DTA.⏳ Pending

🔌 Technical Setup​

TaskDescriptionTimelineStatusDependencies
AWS S3 Bucket configurationSet up and provision the secure S3 bucket for image uploads and results downloads. Provide access credentials to the photography vendor.TBC⏳ PendingContract signed
Dataset ingestion & validationValidate that uploaded images meet quality and format requirements for processing.TBC⏳ PendingS3 bucket ready
Algorithm processing setupConfigure the algorithm pipeline: DIQA, AD diagnosis, EASI scoring per body area.TBC⏳ PendingDataset validated
Pre-production testingEnd-to-end test of upload → processing → results download flow with sample images.TBC⏳ PendingAlgorithm setup

📚 Training​

TaskDescriptionResponsibleStatus
Training session (results interpretation)Train the photography vendor and sponsor teams on how to interpret the coded AI outputs (EASI scores, diagnoses, JSON structure).JD-016, JD-018⏳ Pending

🚀 Project Execution​

TaskDescriptionResponsibleStatus
Full retrospective dataset processingProcess the full dataset of ~3,308 photographs across three studies through the algorithm pipeline.JD-007, JD-005⏳ Pending
Coded results deliveryDeliver coded AI outputs (EASI scores, diagnoses, visit IDs) to the photography vendor in JSON format for reconciliation.JD-007, JD-005⏳ Pending
Meetings and reportingConduct status meetings and provide progress reports as agreed.JD-016, JD-013⏳ Pending
Customer supportProvide ongoing support during execution phase.JD-016⏳ Pending

🔁 Follow-up Meetings (Optional)​

TaskDescriptionResponsibleStatus
Follow-up MeetingFormal review of key findings, feedback, and AI performance results.JD-021, JD-016⏳ Pending
Interim ReportSummary report of current status, insights, and recommendations mid-project.JD-021, JD-016⏳ Pending

✅ Project Close​

TaskDescriptionResponsibleStatus
Final ReportAnalyze final outcomes, compare AI EASI scores against clinician ratings, and document results.JD-021, JD-016⏳ Pending
Define Next StepsOutline future roadmap — potential publication, expanded studies, or additional collaborations.JD-021, JD-016⏳ Pending

Project Leads​

TeamCodeLeader of
Legit.HealthJD-002, JD-008, JD-019Sales Manager, Business Development Manager, Sales Development Representative, Digital Health Manager
Legit.HealthJD-027Project Manager Lead
Legit.HealthJD-013Project Manager
Legit.HealthJD-003Design and Development Manager
Legit.HealthJD-016Customer Success Manager
Legit.HealthJD-018Clinical Research Manager
Legit.HealthJD-004Quality Manager & PRRC
Legit.HealthJD-007, JD-010Technology Manager, Software Developer
Legit.HealthJD-005, JD-009Machine Learning Manager, Medical Data Scientist
Legit.HealthJD-014Data Analyst
QuantificareName SurnameProject Lead (Photography Vendor)
SanofiName SurnameProject Director
SanofiName SurnameProject Lead

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & Person Responsible for Regulatory Compliance (PRRC)
  • Approver: JD-001 General Manager

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Internal Project Tracker: FR Quantificare Sanofi AD Clinical Trials Retrospective
  • Project Overview
  • Project Summary
    • Details
    • Technical Implementation
    • Scope
  • System Architecture
    • Data Flow
  • Project Timeline and Milestones
  • Project Tasks
    • 🧭 Definition & Planning
    • 📝 Contracting
    • 🔌 Technical Setup
    • 📚 Training
    • 🚀 Project Execution
    • 🔁 Follow-up Meetings (Optional)
    • ✅ Project Close
  • Project Leads
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)