R-009-001 ES Novartis 20251104
- Deal Id: 37977642319
- Contract sign date: YYYY MM DD (YYYY MM DD)
- Deal name: ES Novartis - Study Sponsorship - NIPPLE HS Progression
Goals
Goals for 1st year
| Goal | Metric | Target |
|---|---|---|
| Measure impact of AI on HCP decision-making by comparing decisions without AI vs. with AI on the same cases (patients are likely to have severe disease progression to guide appropriate treatment) | NIPPLE-results (correct answer (w/o AI): X% vs correct answer (with AI): Y%) | |
| Positive impact on the continuing education of healthcare professionals. | CUS | |
Project details summary
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Primary Objective: Measure impact of AI on HCP decision-making by comparing decisions without AI vs. with AI on the same cases (patients are likely to have severe disease progression to guide appropriate treatment)
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Integration Type: NIPPLE-HS-Progression
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Features Needed:
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Conditions of Interest: Hidradenitis Suppurativa (HS)
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Languages Supported: TBD. e.g., English, Spanish
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Integration Needs: N/A
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Timeline: TBD e.g., Start integration on 2023-01-01, Go live on 2023-06-01
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Users: TBD e.g., 5 dermatologists, 10 primary care physicians, 100 patients
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Data Handling: N/A
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Challenges: -
Customer's Objective Validation
- Example Report: e.g., Link to example report
- Validation: e.g., Results align with our objectives, Need adjustments in severity assessment
- Next Steps: e.g., Schedule a follow-up meeting to discuss integration details
Project timeline and milestones
To achieve the goals, the parties agree on the following timeline.
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 | ⏳ Pending |
| Definition and planning | Define project details: scope, key deliverables, timelines, success metrics, and required resources. | Deal Owner, JD-013 | ⏳ Pending |
| Implementation plan defined | Project scope, key deliverables, timelines, success metrics, and required resources are defined and clear | Deal Owner & JD-003 or JD-013 or JD-007 | ⏳ Pending |
📝 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 |
🔌 Integration workflow
| Task | Description | Timeline | Status | Dependencies |
|---|---|---|---|---|
| Technical onboarding | Provide comprehensive API documentation, technical walkthroughs, and UI/UX guidance for both patient and HCP views. | TBD | ⏳ Pending | Kick-off meeting |
| API Access | After contract signed, generate and deliver API keys. Access to both production and testing environments. | TBD | ⏳ Pending | Contract signed |
| Professional Services | Expert support from technicians, consultants, and project managers.. Review API input/output structures and align with UI mockups for surface input, scoring feedback, and reports. | TBD | ⏳ Pending | |
| Preproduction environment Testing | Validate integration in pre-prod using sample cases; assess scoring accuracy, latency, and input handling. | TBD | ⏳ Pending | Interface mapping |
| Production environment Testing | Conduct final functional testing with production endpoints using real patient flows and edge cases. | TBD | ⏳ Pending | Concordance validation |
| Launch Readiness & Go/No-Go | Final checklist review, rollback plan, support contact escalation paths, and stakeholder sign-off. | TBD | ⏳ Pending | Optional, depending on work order |
| Customer service deployment into production | Officially deploy the service to production, ensuring all components are live and operational. | 2026-03-01 | ⏳ Pending | |
| Post-Launch Support & Tuning | Provide immediate support coverage, monitor usage patterns, and refine based on real-world feedback. | TBD | ⏳ Pending |
🚀 Project Execution
| Task | Description | Responsible | Status |
|---|---|---|---|
| User Onboarding | Train stakeholders (e.g., medical teams, patients, HCPs) on the app and scoring system. | JD-021, JD-016 | ⏳ Pending |
| Customer Support Enablement | Setup and activate helpdesk or in-app support systems. | JD-021, JD-016 | ⏳ Pending |
| Data Analysis | Perform statistical and clinical analysis on severity scores and patient usage. | JD-021, JD-016, JD-014 | ⏳ 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 plan
This project consists of the following phases:
- Phase 1: Conception and initiation
- Phase 2: Definition and planning
- Phase 3: Pilot execution
- Phase 4: Results analysis and report
- Phase 5: Project close
Phase 1: Conception and initiation
First steps: Initial NIPPLE Questionnaire
The following table contains the information we need to know from the client before starting a "Non-Invasive Prospective Pilot in a Live Environment" project.
info
NIPPLE is the abbreviation we use in this document and internally but it is NOT the formal or proper way to call it for the client.
| Question group | Question | Explanation why we want to know this | Example of expected answer |
|---|---|---|---|
| Starting point overview | - Please indicate if you are a Care provider, Hospital, Clinical trials, Insurance, Pharma /Other,... - How many patients would you see per month? Per year? - Number of in-person patients? - Number of teledermatology patients? - Describe briefly teledermatology system used - Number of Primary Doctors - Number of Dermatology Doctors - Referral (Yes/No) - Describe briefly referral system used | Brief summary about the current situation. The goal is to know what works for them and what does not. Read more info about customer segments | Pharma |
| What you would like to achieve with our solution. | Brief summary. | ... | - HCP decision w/o AI and With AI for HS cases: what category of drug would you recommend? Would this make you reconsider your therapeutic strategy? |
| Objetives | - What do you expect to achieve from this pilot? - What would constitute successful results? - What would constitute unsuccessful results? | The objective of this questions is to make sure that we are aligned before conducting the Pilot on what results we expect to obtain and what we can expect from this Pilot. | Examples: - I expect the results of the pilot to demonstrate how this solution helps professionals in reconsider your therapeutic strategy for HS. - Educational tool. |
| Timelines | When do you want to do the pilot? | ... | TBD YYYY-MM-DD |
| Timelines | When would you like to have the results? | ... | TBD YYYY-MM-DD |
| Dataset | How many images? | Example 1: N=30 images. Time: 1-1,5h. Global results. Example 2: N=100 images. Time: 2,5-3h Global results and by pathology. | TBD |
| Dataset | Who will provide the images for the pilot? When? | - [ ] Company - [ ] Legit.Health. | TBD |
| Dataset | - How many pathologies? - What pathologies? - How many images per pathology? | Define the pathologies for which you want to evaluate how AI helps the professional in the diagnosis and referral. It will depend on the objectives to be assessed. We recommend a minimun of 5 pathologies and 10 images per pathology. | TBD Example: For example, if we want to evaluate the impact of AI in the diagnosis and referral of Melanoma in clinical practice, in the questionnaire we will show cases of Melanoma, Nevus,... |
| Participants | - How many participants will take part of the pilot? - How many primary care (PC)? - How many dermatologists? | The choice of participants will depend on the objectives to be assessed. We recommend a minimum sample size of 6 participants; however, the larger the sample, the better | TBD Example 1: 10 participants (all primary care) Example 2: 15 Participants (10 primary care and 5 dermatologist) |
| Participants | - Who will manage the participation of the participants? | - [ ] Company - [ ] Legit.Health. | TBD |
| Logistics | - Will the pilot be conducted remotely or in person? | - [ ] Remotely - [ ] In person. | TBD |
| Logistics | If remote, - Where? - Who will manage the additional logistical details (tablet rental if necessary, etc.)? | - [ ] Remotely - [ ] In person. | TBD |
| Content | On which of the following points are you most interested? Please rank them from highest to lowest. | (1) Diagnostics (2)Assisted diagnosis (3)Referral - [ ] Yes - [ ] No (4)Telemedicine - [ ] Yes - [ ] No (5)Treatment question (6) Other (I would like to ask other questions, please specify) | Example: 1) (w/o AI AI HS progression output): what category of drug would you recommend? 2) (with AI HS progression output): what category of drug would you recommend? Would this make you reconsider your therapeutic strategy? |
Phase 2: Definition and planning
Project details summary
| Question group | Details | Comments |
|---|---|---|
| Starting point overview | ||
| General objetives. What you would like to achieve with our solution. | - | |
| Pilot objetives | - | |
| Timelines | - Pilot: YYYY-MM-DD - Results: YYYY-MM-DD | |
| Dataset | N=TBD images. Time: 2,5-3h Global results and by pathology. | |
| Participants | TBD dermatologist | |
| Logistics | - Manage the participation of the participants: Hospital del Mar - In person - No additional logistical (tablet rental,...)details | |
| Content | 1) (w/o AI AI HS progression output): what category of drug would you recommend? 2) (with AI HS progression output): what category of drug would you recommend? Would this make you reconsider your therapeutic strategy? |
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 |
| Company Name | Name Surname | Project Director |
| Company Name | 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, JD-004
- Approver: JD-001