R-009-001 ES Novartis 20260331
- Deal Id: 45489188014
- Deal name: ES Novartis - Nipple HS and Erythema
Project Overview
Retrospective analysis study.
Project Summary
Details
- Desired Delivery Date: 2026-MM-DD (TBC)
- Duration: TBC
- Sites: N/A
- Countries: N/A
- Subjects: 200
- Diagnostic Reports: ~1K–3K (TBC)
- Images: Up to 3 images per lesion / 5 timepoints
- Trainings: 1 (to interpret the results)
- Meetings: Weekly meetings and reporting (TBC)
Technical Implementation
- Product: JSON Only (AWS S3 Bucket)
- Conditions: Hidradenitis Suppurativa (HS), Erythema
- Integration: AWS S3 Bucket access for secure upload of original images and download of results (JSON)
Scope
In Scope:
- Automatic Image Quality Control
- Erythema
- Erythema Intensity Quantification
- Lesion count
- Inflammatory Nodular Lesion Quantification
- Nodule Lesion Quantification
- Abscess Lesion Quantification
- Non-Draining Tunnel Lesion Quantification
- Draining Tunnel Lesion Quantification
- AIHS4 Calculation
- Fast progressor detection (as a subgroup)
- Follicular and Inflammatory Pattern Identification
- Input: image
- Output Phenotype: Follicular, Inflammatory, or Mixed
Out of Scope (Not yet available):
- Fibrosis / scarring
- Flare indicators
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
| Task | Description | Responsible | Status |
|---|---|---|---|
| Project conception and initiation | Initial ideation and opportunity scoping with all key stakeholders. | Deal Owner, JD-013 | ✅ Done |
| Definition and planning | Define project details: scope, key deliverables, timelines, success metrics, and required resources. | Deal Owner, JD-013 | 🔄 In Progress |
| Implementation plan defined | Project scope, key deliverables, timelines, success metrics, and required resources are defined and clear | Deal Owner, JD-013 | 🔄 In Progress |
📝 Contracting
| Task | Description | Responsible | Status |
|---|---|---|---|
| Offer Sent | Formal offer/proposal shared with the customer for review. | Deal Owner, JD-002 | ⏳ Pending |
| Offer Approved | Customer reviews and approves the proposed scope, terms, and pricing. | ⏳ Pending | |
| Contract Review | Align on deliverables, timelines, legal and data terms. | ⏳ Pending | |
| Contract Signing | Finalize and sign all contractual agreements. | ⏳ Pending |
🔌 Technical Setup
| Task | Description | Timeline | Status | Dependencies |
|---|---|---|---|---|
| AWS S3 Bucket configuration | Set up and provision the secure S3 bucket for image uploads and results downloads. Provide access credentials to client. | TBC | ⏳ Pending | Contract signed |
| Dataset ingestion & validation | Validate that uploaded images meet quality and format requirements for processing. | TBC | ⏳ Pending | S3 bucket ready |
| Algorithm processing setup | Configure the algorithms pipeline: DIQA, erythema quantification, AIHS4, lesion count, phenotype identification. | TBC | ⏳ Pending | Dataset validated |
| Pre-production testing | End-to-end test of upload → processing → results download flow with sample images. | TBC | ⏳ Pending | Algorithm setup |
📚 Training
| Task | Description | Responsible | Status |
|---|---|---|---|
| Training session (results interpretation) | Train the client team on how to interpret the JSON output and algorithm results. | JD-016, JD-018 | ⏳ Pending |
🚀 Project Execution
| Task | Description | Responsible | Status |
|---|---|---|---|
| Retrospective dataset processing | Process the full dataset of ~200 subjects (~1K–3K images) through the algorithm pipeline via S3 bucket. | JD-007, JD-005 | ⏳ Pending |
| Weekly meetings & reporting | Conduct weekly status meetings and provide progress reports (TBC). | JD-016, JD-013 | ⏳ Pending |
| Customer support | Provide ongoing support during execution phase. | JD-016 | ⏳ Pending |
🔁 Follow-up Meetings (Optional)
| Task | Description | Responsible | Status |
|---|---|---|---|
| Follow-up Meeting | Formal review of key findings, feedback, and performance. | JD-021, JD-016 | ⏳ Pending |
| Interim Report | Summary report of current status, insights, and recommendations mid-project. | JD-021, JD-016 | ⏳ Pending |
✅ Project Close
| Task | Description | Responsible | Status |
|---|---|---|---|
| Final Report | Analyze final outcomes, compare against objectives, and document results. | JD-021, JD-016 | ⏳ Pending |
| Define Next Steps | Outline future roadmap, improvements, or additional collaborations. | JD-021, JD-016 | ⏳ Pending |
Project Leads
| Team | Code | Leader of |
|---|---|---|
| Legit.Health | JD-002, JD-008, JD-019 | Sales Manager, Business Development Manager, Sales Development Representative, Digital Health Manager |
| Legit.Health | JD-027 | Project Manager Lead |
| Legit.Health | JD-013 | Project Manager |
| Legit.Health | JD-003 | Design and Development Manager |
| Legit.Health | JD-016 | Customer Success Manager |
| Legit.Health | JD-018 | Clinical Research Manager |
| Legit.Health | JD-004 | Quality Manager & PRRC |
| Legit.Health | JD-007, JD-010 | Technology Manager, Software developer |
| Legit.Health | JD-005, JD-009 | Machine Learning Manager, Medical Data Scientist |
| Legit.Health | JD-014 | Data Analyst |
| Novartis | Name Surname | Project Director |
| Novartis | Name Surname | Project 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 & PRRC
- Approver: JD-001 General Manager
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