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          • Internal Project Tracker: US J&J AD Biopsy Images Add On
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R-009-001 US Johnson & Johnson Clinical Trial - AD Biopsy Images Add On

  • Deal Id: 57784063799
  • Deal name: US Pharma Johnson & Johnson Clinical Trial - AD Biopsy Images Add On
  • Study ID: ASTAR

Project Summary​

Details​

  • Desired Delivery Date: 2026-06-01 (UAT: 2026-05-25)
  • Duration: 24 months (21-month assessment period)
  • Medical Centers: 6-8
  • Subjects: 60
  • Visits: 1 visit/patient
  • Images per Visit: 6 (6 different images per lesion)
  • Diagnostic Reports: ~360
  • Trainings: 1 Recorded Training, 1 Manual
  • Dashboard: Yes (Sponsor)
  • Anonymization: Yes
  • Data Transfer: Quarterly (images only, includes manifest)
  • Languages: English (en-US)
  • Countries: United Kingdom
  • FPI: 2026-01
  • LPO: 2027-09-30

Technical Implementation​

  • Product: WebApp Clinical Trial platform (BYOD)
  • Features: Automatic Image Quality Control (DIQA), Anonymization, Weekly Meetings and Reporting, Image/Data Archive (15 years)
  • Out of Scope: Severity Assessment (ASCORAD, Pose, BSA)
  • Conditions: Atopic Dermatitis (AD)

Scope​

This project is a "Collect and Hold" initiative for the J&J ASTAR study (Endotyping of Dupilumab-experienced atopic dermatitis patients with asthma), Phase 4 — a study extension. The scope is to provide a WebApp platform for site staff at 6-8 UK-based clinical trial sites to capture and upload 6 lesion photos per subject during a single biopsy visit (1 visit/patient). The 6 photos cover three biopsy locations (non-lesional, lesional, and lesional resolved) captured both pre- and post-biopsy, from a cosmetically accepted area of the body (usually lower back, buttocks, thighs, or arms). The images are for collection and archival purposes only and will not be centrally read or interpreted (ASCORAD, Pose, BSA are out of scope). The underlying objective is to build a dataset for AD phenotyping. The service includes automatic image quality control (DIQA), anonymization of images, quarterly data transfers to J&J (images only, with manifest), weekly meetings and reporting, and a final study report. Data will be archived for 15 years.

Success Metrics​

  • Adherence to Data Transfer Agreement (DTA) specifications.
  • Customer Satisfaction Survey (CSAT) from site staff and study managers.

Doubts, questions and issues​

These are certain issues that need to be solved or clarified in order to clearly define this project.

warning

Any doubt or comment clarified in this section must be accompanied by a modification in its respective section.

  • Sponsor Dashboard: Confirmed — a Sponsor Dashboard is required (Yes).
  • Notifications: Deviation notifications are not required (single timepoint per patient; no way to predict patient entry). For image receipt visibility: site staff can see subject activities in the webapp; the Sponsor has visibility through the dashboard. TAT = Turn Around Time.
  • Imported Timepoints: Not required (TBC). The date/timestamp of image upload will be available automatically.
  • UAT: Target UAT date is 2026-05-25. Specific requirements to be defined after contract signature.
  • Anonymization / Masking: Confirmed — "Masking" in the RFP refers to standard anonymization (blurring, black boxing). No photos of head or neck are taken, so no face masking is needed.
  • Retrospective Data: Confirmed — retrospective photos taken before contract signing do not require management by us.
  • Protocol Document: Confirmed — there is no imaging protocol. The existing ASTAR protocol covers molecular data and samples only. No imaging-specific protocol is expected.

General Study Setup timeline​

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

warning

The dates provided in the timeline are for reference purposes only; final dates will be determined following contract signature.

info

The timeline is based on the following assumptions:

  • Contract signing occurs by mid-May 2026.
note

This timeline is subject to change based on contract negotiations, final protocol requirements, and any unforeseen circumstances during project execution. Regular updates will be provided to all stakeholders to ensure alignment and timely adjustments as needed.

info

Pending to confirm Data Archival (15 years)

Project tasks​

🧭 Definition & planning​

TaskDescriptionResponsibleStart DateEnd DateStatusNotes
Project conception and initiationInitial discussions and alignment on project feasibility.Deal Owner2026-03-032026-03-27✅ DoneBased on internal meetings and client communications.
RFP ReceivedJ&J sent the formal Request for Proposal to Legit.Health.J&J2026-03-272026-03-27✅ Done
Offer & SOW DefinitionCreate and send the formal offer and Statement of Work based on the RFP.Deal Owner2026-03-302026-04-10🔄 In ProgressPending approval from J&J.
ContractingReview and finalize the SOW and all contractual agreements, including the DTA.Deal Owner & Client2026-04-102026-05-08⏳ Pending

🏁 Kickoff & Setup​

TaskDescriptionResponsibleStart DateEnd DateStatus
Internal Kick-off MeetingAlign internal teams (OSD, MDS) on project goals, timelines, and responsibilities.Deal Owner2026-05-112026-05-11⏳ Pending
Platform ConfigurationSet up the WebApp environment for the ASTAR study, including specific UI for the clinical trial.OSD Team (D. Sanchez)2026-05-122026-05-26⏳ Pending
Data Transfer ConfigurationConfigure the quarterly Data Transfer Agreement (DTA) specifications and bucket credentials.MDS Team2026-05-122026-05-26⏳ Pending

🔬 UAT & Training​

TaskDescriptionResponsibleStart DateEnd DateStatus
User Acceptance Testing (UAT)J&J and site representatives test the platform to ensure it meets requirements.Client & J. Roca2026-05-272026-06-09⏳ Pending
Training Material CreationCreate Investigator Manual and recorded video training for site staff on how to use the WebApp.J. Roca2026-06-102026-06-17⏳ Pending

🚀 Project Execution​

TaskDescriptionResponsibleStart DateEnd DateStatus
Go-LiveThe platform is live for sites to begin capturing and uploading images.All Teams2026-05-302026-05-30⏳ Pending
Subject AssessmentsSite staff capture and upload images for 60 subjects over the 21-month assessment period.Client (Site Staff)2026-05-302027-09-30⏳ Pending
Quarterly Data TransfersExecute automated data transfers to the specified J&J bucket each quarter.MDS Team2026-08-302027-09-30⏳ Pending
Support & MaintenanceProvide ongoing support to site staff and J&J project managers.J. Roca2026-05-302027-09-30⏳ Pending

Clinical Workflows​

This section provides the implementation guidelines and clinical logic for the J&J ASTAR "Collect and Hold" project.

System Architecture & Logic​

Image Capture via WebApp (BYOD)​

Site staff will use their own devices (Bring Your Own Device) to access a dedicated Legit.Health WebApp. This app is for image capture and upload only. There is no backend integration with other J&J systems.

Interaction Flow​

Anonymization​

Based on requirements from similar J&J projects, a multi-step anonymization process will be applied to all images before they are transferred.

  • Automatic Blurring: The background surrounding the body area will be automatically blurred.
  • Automatic Black Boxing: Black boxes will be placed over eyes and mouths if visible.
  • Manual Black Boxing: A manual review step can be included to place black boxes over other identifiable features like tattoos or jewelry, if required by the final protocol.
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Internal Project Tracker: US J&J AD Biopsy Images Add On
  • Project Summary
    • Details
    • Technical Implementation
    • Scope
    • Success Metrics
  • Doubts, questions and issues
  • General Study Setup timeline
  • Project tasks
    • 🧭 Definition & planning
    • 🏁 Kickoff & Setup
    • 🔬 UAT & Training
    • 🚀 Project Execution
  • Clinical Workflows
    • System Architecture & Logic
      • Image Capture via WebApp (BYOD)
        • Interaction Flow
      • Anonymization
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.)