R-009-001 US Johnson & Johnson 20250505
- Deal Id: 17976035487
Project details
- Sponsor: Johnson & Johnson
- CRO: TBD
- Project name: US Johnson & Johnson Clinical Trial
- Phase: 3
- Sites: 100
- Subjects: 200
- Assessments: ?
- Visits: 5 (baseline and 4 follow up)
- Window of assessments: 24 months
- Participation duration in months: TBD months
Study timeline
Estimated dates assuming Visit 1 (Baseline) starts on: V1, 2025-03-15
General Study Setup timeline
To achieve the goals, the parties agree on the following timeline.
Estimated dates assuming Visit 1 (Baseline) starts on: V1, 2025-03-15
Data flow
Note: Green elements are included in the scope of the project by the customer, while grey elements are not included.
Data flow
Project definition details summary
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Primary Objective: Enable a decentralized clinical trial for Atopic Dermatitis (AD), allowing patients to capture and upload their own images from home.
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Integration Type: Clinical Trials Webapp
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Key features required:
- Image quality analysis
- POSE models to guide patients in capturing standardized photos across 7 predefined body areas.
- Patients will upload images via the platform but will not have access to any visual feedback/information.
- Algorithms will process images solely for image quality validation — there will be NO diagnostic or severity analysis involved.
- In-app guidance for photo taking (7 perspectives)
- In-app pose estimation model for the 7 perspectives
- Anonymization:
- Everything that doesn't contain a lesion is pixelated.
- Blur the background.
- Segmentation: mouth, face, eyes – cover them with black squares.
- Tattoos: it's impossible to guarantee it works well in all cases; it's okay as long as we try they understand the limitation.
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Translations:
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Webapp: (*) 7 Required languages:
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Patient face materials: (*) 7 Required languages:
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Investigator's manual: English only
(*) 7 Required languages: Hungarian, Austrian German,Danish, Spanish, English, Polish, and German.
(TO BE CONFIRMED)
Note: All patient-facing content should be translated.
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The site investigator will grant access to patients.
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The site investigator will be able to view the images.
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Dashboard: no included in the scope of this project.
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Conditions of Interest: Atopic Dermatitis (AD), Psoriasis
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Project Definition: TBD
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Data Transfer: Yes, monthly Automated. Via REST API. S3 export or sFTP.
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Timeline: No yet defined, but the study is expected to start in 2026.
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Other comments:
- In 1-2 months will have the protocol. Study will start next year 2026 (we may sign the contract in 2025?)
- The solution is focused exclusively on supporting clinical image acquisition workflows in a decentralized setting, with strict separation from any diagnostic functionality.
Image perspectives
The severity may be measured using the data from 7 images. Each images captures a specific perspetive of the body. The following image shows the 7 perspectives and how they are related to measuring the involvement of the body surface area (BSA) in psoriasis.
Training sessions
The following table outlines the scheduled and to-be-determined (TBD) group training sessions for different regions. It provides a clear breakdown of the training sessions by location.
Training Sessions Breakdown
| Region | Group Trainings number | Status |
|---|---|---|
| United States (US) | N group trainings | TBD |
| Europe (EU) | N group trainings | TBD |
| Total | N group trainings |
Training sessions schedule time table
PST (Pacific Standard Time), EST (Eastern Standard Time),CST (Central Standard Time) and CET (Central European Time)
| Date | Region | Site local time | Legit.Health local time (CET) |
|---|---|---|---|
| TBD | US | TBD | TBD |
| TBD | US | TBD | TBD |
| TBD | EU | TBD | TBD |
| TBD | EU | TBD | TBD |
Time Zone Conversion Table
| CET (Central European Time) | PST (Pacific Standard Time) | EST (Eastern Standard Time) | CST (Central Standard Time) | More |
|---|---|---|---|---|
| 3:00 PM CET (15:00) | 6:00 AM PST | 9:00 AM EST | 8:00 AM CST | TBD |
| 4:00 PM CET (16:00) | 7:00 AM PST | 10:00 AM EST | 9:00 AM CST | TBD |
| 5:00 PM CET (17:00) | 8:00 AM PST | 11:00 AM EST | 10:00 AM CST | TBD |
| 6:00 PM CET (18:00) | 9:00 AM PST | 12:00 PM EST | 11:00 AM CST | TBD |
| 7:00 PM CET (19:00) | 10:00 AM PST | 1:00 PM EST | 12:00 PM CST | TBD |
| 8:00 PM CET (20:00) | 11:00 AM PST | 2:00 PM EST | 1:00 PM CST | TBD |
| 9:00 PM CET (21:00) | 12:00 PM PST | 3:00 PM EST | 2:00 PM CST | TBD |
| 10:00 PM CET (22:00) | 1:00 PM PST | 4:00 PM EST | 3:00 PM CST | TBD |
| 11:00 PM CET (23:00) | 2:00 PM PST | 5:00 PM EST | 4:00 PM CST | TBD |
Alerts workflow
Project tasks
| Task | Description | Responsible |
|---|---|---|
| Investigator's manual web platform | Developing and providing access to the investigator's manual | JD-013, JD-016 |
| Set up of the platform | Setting up the platform | JD-007, JD-010 |
| Account access | Providing access to relevant accounts | JD-016, JD-007, JD-010 |
| Certified training sessions | Conducting certified training for team members | JD-016 |
| Custom dashboard development | Designing and implementing a custom dashboard for the study | JD-014 |
| Defining Data Transfer Agreement (DTA) specifications | Creating and defining the Data Transfer Agreement for sharing data | Deal Owner, JD-003, JD-013 |
| Translations | Translating materials into the required custom language | JD-007, JD-010 |
| Data Transfer | Managing and securing the transfer of study data | JD-016, JD-014, JD-003, JD-013 |
| Oversight | Overseeing the study’s progress and ensuring compliance | Deal Owner, JD-016 |
| Technical and clinical support | Providing ongoing technical and clinical support | JD-016, JD-013, JD-003, JD-005, JD-007, JD-018, JD-004 |
| Image anonymisation | Ensuring anonymisation of images used in the study | JD-003, JD-005, JD-009 |
| Customer Support | Providing assistance and answering questions from study participants | JD-016 |
| Project Close | Finalizing the study, reviewing results, and preparing the final report | JD-016, JD-021 |
Note: All details are in the contract.
The following roles will be present in all project stages and tasks: Deal Owner, JD-013, JD-003, JD-001.
Account accesses
Project tasks and subtasks
| Task | Description | Responsible |
|---|---|---|
| Investigator's manual web platform | Developing and providing access to the investigator's manual | JD-013, JD-016 |
| Set up of the platform | Setting up the platform | JD-007, JD-010 |
| Account access | Providing access to relevant accounts | JD-016, JD-007, JD-010 |
| Certified training sessions | Conducting certified training for team members | JD-016 |
| Custom dashboard development | Designing and implementing a custom dashboard for the study | JD-014 |
| Custom dashboard development | Important. Dashboard should be set to "unlisted" in sharing options. | JD-014 |
| Defining Data Transfer Agreement (DTA) specifications | Creating and defining the Data Transfer Agreement for sharing data | Deal Owner, JD-003, JD-013 |
| Translations | Translating materials into the required custom language | JD-007, JD-010 |
| Data Transfer | Managing and securing the transfer of study data | JD-016, JD-014, JD-003, JD-013 |
| Oversight | Overseeing the study’s progress and ensuring compliance | Deal Owner, JD-016 |
| Technical and clinical support | Providing ongoing technical and clinical support | JD-016, JD-013, JD-003, JD-005, JD-007, JD-018, JD-004 |
| Image anonymisation | Ensuring anonymisation of images used in the study | JD-003, JD-005, JD-009 |
| Customer Support | Providing assistance and answering questions from study participants | JD-016 |
| Project Close | Finalizing the study, reviewing results, and preparing the final report | JD-016, JD-021 |
Project task tracker
| Task | Description | Start Date | End Date | Status | Notes |
|---|---|---|---|---|---|
| Project On Hold | Temporary pause of the project notified by Katharine (Johnson & Johnson) Email | 2025-03-19 | TBD | ⏸️ On Hold | Pending decision from Johnson & Johnson. |
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-003, JD-013 | Design and Development Manager, Project 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 |
| Legit.Health | JD-016 | Customer Success Manager |
| Legit.Health | JD-021 | Account Manager |
| 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