R-009-001 US Johnson & Johnson 20250505
- Deal Id: 17976035487
Project details
- Sponsor: Johnson & Johnson
- CRO: TBD
- Project name: US Johnson & Johnson Clinical Triall, DSIMM-EASTMAN project
- Phase: 3, Long Term Extension (LTE)
- Sites: 100
- Subjects: 200
- Photography visits: 5 (baseline and 4 follow ups). 7 images per visit (7 perspectives). TBC if +4 images per visit (close-ups of lesions)
- Window of assessments: 24 months
- Starting Date: 2026-04-01
- Finish Date: 2028-04-01
Study timeline
The following timeline is tentative and subject to change based on project requirements and depending on the contract signing date.
Estimated dates assuming Visit 1 (Baseline) starts on: V1, 2026-04-01
General Study Setup timeline
To achieve the goals, the parties agree on the following timeline.
Estimated dates assuming Visit 1 (Baseline) starts on: V1, 2026-04-01
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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Overview: Efficacy evaluations in clinical studies of drug interventions for the treatment of dermatological conditions such as psoriasis (PsO) require frequent in-person physical examinations of participants’ skin using standardized assessments such as Psoriasis Area and Severity Index (PASI). In-person assessments can be burdensome to participants and investigators, especially true during Long Term Extensions (LTE) in which participants can be monitored for several years. J&J developed an automated method for scoring disease severity from images captured at home by participants, with the aim to deploy in dermatology trials to reduce participant burden and trial costs. Partnering with Legit.health to deploy their mobile application on Apple phones, J&J intends to replace specific on-site visits with at-home participant self-images via the Legit.health application. These self-images will then be assessed by J&J DSIMM’s automated method applying the same clinical scoring.
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Primary Objective: Objective: to reduce participant burden and trial costs by enabling at-home image capture and automated severity scoring in dermatology trials.
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Conditions of Interest: Psoriasis
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Integration Type: Clinical Trials Webapp
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Key features required:
- Algorithms will process images solely for image quality validation — there will be NO diagnostic or severity analysis involved.
- TBC 2 scenarios to explore:
- Scenario 1: Not using Legit.health PASI Scoring Algorithm. Legit.Health will block the access to severity assessment algorithms (PASI)
- Scenario 2: Using Legit.health PASI scoring algorithm in parallel with J&J's
- In-app guidance for photo taking (7 perspectives)
- In-app POSE models to guide patients in capturing standardized photos across 7 predefined body areas.
- The platform will hide the image analysis results from the patients after they have submitted their photos. Patients won’t have access to any visual feedback or information
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Anonymization:
- 2025-08-26 J&J confirmed that image anonymization is not required
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Translations:
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Webapp: (*) 7 Required languages:
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Investigator's manual: English only
- Patient manual: (*) 7 Required languages:
(*) 7 Required languages: Hungarian, Austrian German,Danish, Spanish, English, Polish, and German.
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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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TBC: The site investigator will be able to see the PASI scores.
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Dashboard: TBD
- Filters: TBD
- Include images *: TBD
- Exports: csv export
- Other: TBD
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Data Transfer: Yes, monthly Automated. Via REST API, S3 export or sFTP.
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Timeline: study is expected to start in April 1st, 2026.
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Other comments:
- the clinical protocol to be shared. Study will start 2026-04-01 (we will sign the contract in Q4 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 |
| 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 overview
| Task | Description | Responsible |
|---|---|---|
| Investigator/Patient manual web platform | Developing and providing access to the 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 |
| 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 tasks
🧭 Definition & planning
| Task | Description | Start Date | End Date | Status | Notes |
|---|---|---|---|---|---|
| Project conception and initiation | Initial ideation and opportunity scoping with all key stakeholders. | TBD | TBD | 🚧 WIP | |
| Definition and planning | Define project details: scope, key deliverables, timelines, success metrics, and required resources. | TBD | TBD | ⏳ Pending | |
| Implementation plan defined | Project scope, key deliverables, timelines, success metrics, and required resources are defined and clear | TBD | TBD | ⏳ Pending |
🛠️ Study setup planning
| Task | Description | Start Date | End Date | Status | Notes | | ---------------------------------------- | ---------------------------------------------------------- | -------------- | ------------ | ---------- | ----------------------------------------------------------------- | --- | | Investigator/Patient manual web platform | Definition of investigator/Patient manual web platform | TBD | TBD | ⏳ Pending | | | Set up of the platform | Definition of initial setup and configuration of platform. | TBD | TBD | ⏳ Pending | | | Addition of new features | Definition of additional features | TBD | TBD | ⏳ Pending | | | Custom dashboard development | Definition of dashboards with study-specific metrics. | TBD | TBD | ⏳ Pending | | | Defining Data Transfer Agreement (DTA) | Definition of specifications for secure data transfer. | TBD | TBD | ⏳ Pending | | | Other detail | Definition of additional setup tasks as required. | TBD | TBD | ⏳ Pending | 2025-08-26 J&J confirmed that image anonymization is not required | |
📝 Contracting
| Task | Description | Start Date | End Date | Status | Notes |
|---|---|---|---|---|---|
| Offer Sent | Formal offer/proposal shared with the customer for review. | TBD | TBD | ✅ Done | |
| Offer Approved | Customer reviews and approves the proposed scope, terms, and pricing. | TBD | TBD | ✅ Done | |
| Contract Review | Align on deliverables, timelines, legal and data terms. | TBD | TBD | ⏳ Pending | |
| Contract Signing | Finalize and sign all contractual agreements. | TBD | TBD | ⏳ Pending |
🛠️ Study setup
| Task | Description | Start Date | End Date | Status | Notes |
|---|---|---|---|---|---|
| Investigator's manual web platform | Build and configure investigator-facing portal. | TBD | TBD | ⏳ Pending | |
| Set up of the platform | Initial setup and configuration of platform. | TBD | TBD | ⏳ Pending | |
| Addition of new features | Development of new features | TBD | TBD | ⏳ Pending | |
| Custom dashboard development | Build dashboards with study-specific metrics. | TBD | TBD | ⏳ Pending | |
| Defining Data Transfer Agreement (DTA) | Define specifications for secure data transfer. | TBD | TBD | ⏳ Pending | |
| Other detail | Additional setup tasks as required. | TBD | TBD | ⏳ Pending |
📚 Training
| Task | Description | Date | Status | Notes |
|---|---|---|---|---|
| Practice training 1 | First practice training session. | 2026-MM-DD (hh:mm CET) | ⏳ Pending | |
| Practice training 2 | Second practice training session. | 2026-MM-DD (hh:mm CET) | ⏳ Pending | |
| Demo training | Demonstration training session. | 2026-MM-DD (hh:mm CET) | ⏳ Pending | |
| Training sessions | Conduct N training sessions in total. | 2026-MM-DD (hh:mm CET) | ⏳ Pending |
🧮 User Acceptance Test (UAT)
| Task | Description | Responsible | Date | Status | Notes |
|---|---|---|---|---|---|
| Account creation | Create test accounts for UAT. | JD-016, JD-007, JD-010 | 2026-MM-DD (hh:mm CET) | ⏳ Pending | |
| Training sessions | Conduct training sessions for UAT participants. | JD-016 | 2026-MM-DD (hh:mm CET) | ⏳ Pending | |
| UAT project execution | Execute UAT plan, gather feedback, and document results. | JD-021, JD-016 | 2026-MM-DD (hh:mm CET) | ⏳ 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 |
🔑 Account creation and access
| Task | Description | Date | Status | Notes |
|---|---|---|---|---|
| Account creation and access | Administrator account creation and access - explanation meeting (includes up to 4 users per site) | 2026-MM-DD | ⏳ Pending | |
| Delivery Account creation and access files | Legit.Health will send you the necessary files to gather information for the sites, the platform's initial site users, and the users who will have access to the dashboard. | 2026-MM-DD | ⏳ Pending | |
| File Delivery | Delivery of the required files to J&J | 2026-MM-DD | ⏳ Pending | |
| Reception of files | Receiving the files from J&J | 2026-MM-DD | ⏳ Pending | |
| Account creation for site personnel | Includes up to 4 users per site. Note: Legit.Health will create accounts for the users provided in the files. Any inaccuracies or errors in the file contents shall not be the responsibility of Legit.Health and must be rectified by J&J, if necessary. | 2026-MM-DD | ⏳ 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-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