R-009-001 IT Chiesi Epidermolisis Bullosa 2026
- Deal Id: 50770239073
- Deal name: IT Chiesi Epidermolisis Bullosa 2026
Project Summary
Details
- Desired Start Date: 2026-05
- Duration: 12 months
- Medical Centers: Up to 10
- Patients: 300
- Diagnostic Reports: 50k/year
- Trainings: Up to 10 (1 per medical center)
- Follow-ups: 3 meetings (TBD)
- Dashboard: 1
- Languages: Spanish, Italian, English
- Countries: EU
Technical Implementation
- Product: Clinical Trial WebApp
- Note: This is an exception, as patient progression is a deal broker and the number of patients is limited.
- Features: DIQA + Severity Assessment
- px2px algorithm (AI markers: at least 2, ideally 4)
- AWOSI Scoring System
- Conditions: Epidermolysis Bullosa
- URL/Domain:
clinicaltrial.legit.health(standard URL, no custom domain)
Scope
The project aims to promote engagement and adherence to Chiesi's treatment by monitoring weekly how patients’ wounds reduce in surface area.
Success Metrics
TBD
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.
- Dashboard Requirements: Specific metrics and widgets for the custom dashboard need to be defined.
- Success Metrics: It must be defined how the success of the project will be measured.
- Follow-up Meetings: It must be defined how the follow-up meetings will be conducted. Is it mandatory to have them? If so, how often?
Clinical Endpoints
Legit.Health will be utilised to measure the degree of patient affectation and track the change in wound dimensions.
Data will be captured by the patients following doctor’s instructions. The solution will extract and record the following specific endpoints:
Physical Measurements
info
Visibility: Both doctors and patients will have access to that information.
Precise physical measurements of the wound using the px2px algorithm. All physical measurements (Area, Perimeter, Depth, Volume, Dimensions) will be offered.
| Measurement | Format |
|---|---|
| Area | cm² |
| Perimeter | cm |
| Depth | ± cm |
| Volume | cm³ |
| Dimensions | mm × mm |
AWOSI Scoring System
info
Visibility: Only doctors will have access to that information.
The AWOSI scoring system offers a comprehensive evaluation of wound severity and healing progress by assessing 24 clinical signs, each with its corresponding mask. All 24 clinical signs and their visual masks will be exposed.
| Category | Clinical Signs |
|---|---|
| Wound Edges | Damaged, Delimited, Diffuse, Thickened, Indistinguishable |
| Perilesional Area | Erythema (General), Perilesional erythema, Perilesional maceration |
| Tissue Characterization | Biofilm compatible, Bone and/or adjacent, Dermis and epidermis, Muscle, Subcutaneous, Healed skin |
| Exudate | Fibrinous, Purulent, Sanguineous, Serous, Greenish |
| Wound Bed Tissue | Healed, Sloughy, Necrotic, Granulation, Epithelial |
Image Acquisition Instructions
To ensure the highest accuracy in the clinical endpoints and longitudinal analysis, proper image acquisition is critical.
Detailed instructions will be provided in the Investigator Manual. However, key principles for optimal photography include:
- Use the AI Marker: Place near the wound.
- Quantity:
- 1 marker: Incompatible with 3D reconstruction (requires extrapolation, yielding suboptimal results).
- 2 markers: Absolute minimum, but yields lower precision.
- 4 markers: Recommended for optimal balance.
- Placement: They can be placed on the surrounding surface or sheets. They should be dispersed in the image, not necessarily touching the wound.
- Adhesion: Markers must not be attached to the patient's skin due to EB sensitivity. Use non-adhesive methods (e.g., placing them on flat surfaces surrounding the wound).
- Size: Approximately 12mm (10mm content + border)
- Distance: ~30cm from the wound.
- Quantity:
- Lighting: Ensure uniform lighting conditions, avoiding shadows or overexposure.
- Focus: Keep the wound and marker in sharp focus.
- Perspective: Take the photo as parallel as possible to the wound surface. Standardizing the shooting angle avoids measurement distortion and ensures a consistent visual guide for wound evolution, even when using markers.
Project timeline and milestones
warning
The dates provided in the timeline are for reference purposes only; final dates will be determined following contract signature and will not commence before April 2026.
Project tasks
🧭 Definition & planning
| Task | Description | Responsible | Start Date | End Date | Status | Notes |
|---|---|---|---|---|---|---|
| Project conception and initiation | Initial ideation and opportunity scoping with all key stakeholders. | Deal Owner & JD-013 | 2026-02-01 | 2026-03-01 | ✅ Done | Initial proposal presented |
| Definition and planning | Define project details: scope, key deliverables, timelines, success metrics, and required resources. | Deal Owner & JD-013 | 2026-03-02 | 2026-03-20 | ⏳ In Progress | Defining final specs |
| Implementation plan defined | Project scope, key deliverables, timelines, success metrics, and required resources are defined and clear | Deal Owner & JD-013/JD-027 | 2026-03-20 | 2026-03-20 | ⏳ Pending |
📝 Contracting
| Task | Description | Responsible | Start Date | End Date | Status | Notes |
|---|---|---|---|---|---|---|
| Offer Sent | Formal offer/proposal shared with the customer for review. | Deal Owner & JD-002 | 2026-03-20 | 2026-03-20 | ⏳ Pending | Awaiting Definition & Planning closure |
| Offer Review | Customer internal review period. | Client | 2026-03-20 | 2026-04-04 | ⏳ Pending | |
| Offer Approved | Customer reviews and approves the proposed scope, terms, and pricing. | Client | 2026-04-04 | 2026-04-04 | ⏳ Pending | |
| Contract Review | Align on deliverables, timelines, legal and data terms. | Deal Owner & Client | 2026-03-20 | 2026-04-19 | ⏳ Pending | GDPR & URL discussion |
| Contract Signing | Finalize and sign all contractual agreements. | Client | 2026-04-19 | 2026-04-19 | ⏳ Pending |
🏁 Kickoff
| Task | Description | Responsible | Date | Status |
|---|---|---|---|---|
| Kick-off Meeting | Initial meeting to align on project goals, timelines, and responsibilities. | Deal Owner & JD-016/JD-029 (Optional: JD-013/JD-027) | 2026-04-22 | ⏳ Pending |
🛠️ Development
| Task | Description | Responsible | Start Date | End Date | Status |
|---|---|---|---|---|---|
| Development | Integration of px2px algorithm, AWOSI specific configurations, and clinical trial environment. | JD-010/JD-007 | 2026-04-19 | 2026-05-19 | ⏳ Pending |
| Custom Dashboard | Development of the custom dashboard with defined metrics. | JD-014 | 2026-04-19 | 2026-05-04 | ⏳ Pending |
| Internal Testing | Comprehensive validation of the platform features, data accuracy, and user flows. | JD-029/JD-016 | 2026-05-15 | 2026-05-19 | ⏳ Pending |
🚀 Project Execution
| Task | Description | Responsible | Start Date | End Date | Status |
|---|---|---|---|---|---|
| Trainings | Train doctors from medical centers to use the platform. | Deal Owner & JD-029/JD-016 | 2026-05-19 | 2026-05-26 | ⏳ Pending |
| Customer Support | Setup and activate helpdesk or in-app support systems. Comprehensive assistance for complex issues | Deal Owner & JD-029/JD-016 | 2026-05-26 | 2027-05-26 | ⏳ Pending |
🔁 Follow-up Meetings (TBD if needed)
| Task | Description | Date | Responsible | Status |
|---|---|---|---|---|
| 1º Follow-up | Formal review of key findings, feedback, and performance. | 2026-08-24 | Deal Owner & JD-029/JD-016 | ⏳ Pending |
| 2º Follow-up | Formal review of key findings, feedback, and performance. | 2026-11-22 | Deal Owner & JD-029/JD-016 | ⏳ Pending |
| 3º Follow-up | Formal review of key findings, feedback, and performance. | 2027-02-20 | Deal Owner & JD-029/JD-016 | ⏳ Pending |
✅ Project Close
| Task | Description | Start Date | End Date | Responsible | Status |
|---|---|---|---|---|---|
| Final Report | Analyze final outcomes, compare against objectives, and document results. | 2027-05-26 | 2027-06-02 | Deal Owner & JD-029/JD-016 | ⏳ Pending |
| Final Meeting | Formal review of the final report and project closure discussion. Also, define next steps if possible to continue collaboration. | 2027-06-03 | 2027-06-03 | Deal Owner & JD-029/JD-016 | ⏳ Pending |
Technical analysis and details
This section provides technical specifications and implementation guidelines for developers working on the Chiesi EB Clinical Trial WebApp project.
System Architecture
Key Technical Components:
- Clinical Trial WebApp: Standalone web application hosted at
clinicaltrial.legit.health. - Wound-Centric Architecture:
- Wound Creation: Patients can create distinct profiles for each wound (e.g., "Left Knee", "Right Elbow").
- Longitudinal Tracking: Photos are uploaded to specific wound profiles to ensure accurate longitudinal tracking of that specific lesion.
- Role-Based Access:
- Patient Role:
- Access: Patients can only access their own uploaded data.
- Visible Data: Patients may view their physical measurements—area, perimeter, depth, volume, and dimensions—and track the longitudinal evolution of their wound area.
- Restricted Data: Patients do not have access to AWOSI scores, the breakdown of clinical signs, or any visual masks.
- Doctor Role:
- Access: Doctors have full access to all patients assigned to their cohort.
- Visible Data: Doctors can view a comprehensive clinical overview, including all physical measurements (with longitudinal evolution), AWOSI scoring system results (total score), the table of 24 clinical signs, visual masks, and the evolution of the AWOSI score over time.
- Capabilities: Doctors can onboard new patients via email and access cohort-level analytics.
- Patient Role:
- DIQA (Dermatology Image Quality Assurance): Real-time image quality assessment during upload.
- Marker Detection: Automated detection of markers in the image. Images with fewer than 2 markers are rejected.
- px2px Algorithm (Physical Measurements):
- Visibility: Available to Patients & Doctors.
- Single Report Measurements: Calculates and displays Area (cm²), Perimeter (cm), Depth (± cm), Volume (cm³), and Dimensions (mm × mm) for each image.
- Evolution: Tracks the longitudinal evolution of the Wound Area over time within the same wound profile.
- AWOSI Scoring System (Severity Assessment):
- Visibility: Available to Doctors ONLY (Strictly hidden from patients).
- Single Report Data: Calculates the total AWOSI Score, provides a detailed breakdown of the 24 clinical signs detected, and overlays visual masks on the image for verification.
- Evolution: Tracks the longitudinal evolution of the AWOSI Score over time within the same wound profile.
- Custom Dashboard: Visualization of clinical trial metrics (TBD).
User Stories
Patient Stories
- US-001: As a Patient, I want to log in securely to the platform, so that I can upload my wound photos.
- US-011: As a Patient, I want to create a new wound profile (e.g., "Right Leg Ulcer"), so that I can organize my uploads and track the evolution of each wound separately.
- US-002: As a Patient, I want to upload a photo to a specific wound profile (with markers placed nearby), so that it can be analyzed in the correct context.
- US-003: As a Patient, I want to receive immediate feedback if my photo is blurry, poor quality, or has fewer than 2 markers, so that I can retake it.
- US-004: As a Patient, I want to see the evolution of my wound's surface area over time, so that I am motivated to continue treatment. Note: For each specific photo, I can also view detailed measurements (Perimeter, Depth, Volume, Dimensions), but the history chart focuses on Area. (I must NOT see any AWOSI scores, clinical signs, or visual masks).
- US-005: As a Patient, I want the interface to be in my native language (Spanish, Italian, or English), so that I can understand the instructions clearly.
Healthcare Professional Stories
- US-006: As a Doctor, I want to onboard new patients by sending an email invitation, so that they are automatically assigned to me upon registration.
- US-007: As a Doctor, I want to view a list of my assigned patients, so that I can track their status.
- US-008: As a Doctor, I want to access detailed reports for each patient immediately after upload (no validation required), including all Physical Measurements (Area, Perimeter, Depth, Volume, Dimensions) and AWOSI scores.
- US-009: As a Doctor, I want to visualize the 24 clinical signs detected by AWOSI with their corresponding visual masks on the image, so that I can verify the AI's findings.
- US-010: As a Doctor, I want to see a longitudinal dashboard of the patient's wound evolution (including both Wound Area and AWOSI Score trends), so that I can detect trends or issues early.
Developer Stories
- DEV-001: As a developer, I want to configure the px2px algorithm to reject images with fewer than 2 markers, so that 3D reconstruction is always possible and accurate.
- DEV-002: As a developer, I want to implement the AWOSI scoring system to detect all 24 defined clinical signs, so that the full severity assessment is available.
- DEV-0043: As a developer, I want to implement a "Wound Selector" component in the upload flow, so that images are correctly associated with a specific wound ID.
Required Input Parameters
The following parameters are required for the system to function correctly:
| Parameter | Type | Required | Description | Usage |
|---|---|---|---|---|
| Image | File | Yes | Photo of the wound containing at least 2 AI Markers | Primary analysis input |
| Patient ID | String | Yes | Unique identifier for the patient | Link data to record |
| Wound ID | String | Yes | Unique identifier for each wound profile (e.g., UUID or label) | Distinguish and track each wound |
| Wound Location | String | Yes | Anatomical location (e.g., "Left Leg") | Longitudinal tracking consistency |
Use Cases
| Use Case | Input | Expected Output | Observed Output |
|---|---|---|---|
| UC-001: Patient Upload - Success | Patient uploads a focused photo with >= 2 markers | DIQA approves. System calculates Physical & AWOSI. Patient sees: Updated Wound Area evolution chart. Doctor sees: Full report (Physical + AWOSI + Masks). | Pending |
| UC-002: Patient Upload - Poor Quality | Patient uploads a blurry or dark photo | DIQA rejects image immediately. User prompted to retake with specific tips (e.g., "Image is blurry"). | Pending |
| UC-003: Patient Upload - Insufficient Markers | Patient uploads photo with < 2 markers | System rejects image. User prompted to retake with at least 2 markers. | Pending |
| UC-004: Doctor View - Full Analysis | Doctor opens patient report | Doctor sees Physical Measurements + AWOSI Score + Breakdown of 24 signs + Visual Masks on image. | Pending |
| UC-005: Patient View - Restricted | Patient views their wound history | Patient sees evolution of Wound Area ONLY. (AWOSI scores, signs, and masks are hidden). | Pending |
| UC-006: Longitudinal Analysis (Doctor) | Doctor views patient history | Dashboard shows trend lines for both Wound Area and AWOSI Score evolution over time. | Pending |
| UC-007: Patient Onboarding | Doctor enters patient email | Patient receives invitation. Upon registration, patient is automatically linked to the Doctor's cohort. | Pending |
Testing Checklist
- DIQA Validation: Verify rejection of blurry, dark, or off-target images immediately after upload.
- Marker Detection Rules:
- < 2 Markers: Ensure system rejects the image and prompts user to retake.
- >= 2 Markers: Ensure system accepts the image and proceeds to analysis.
- Physical Measurements Accuracy: Validate accuracy of Area, Perimeter, Depth, and Volume against ground truth (calibrated objects).
- AWOSI Scoring System:
- Verify detection of all 24 clinical signs.
- Verify visual masks are correctly overlaid on the image.
- Role-Based Access Control (RBAC):
- Patient View: Ensure Patient can ONLY see Physical Measurements (Area, Volume, etc.) and CANNOT see AWOSI scores, clinical signs, or masks.
- Doctor View: Ensure Doctor can see EVERYTHING (Physical Measurements + AWOSI Scores + Masks + Evolution).
- Data Isolation: Ensure Patients cannot access other patients' records.
- Wound Profiling & Longitudinal Tracking:
- Verify that photos uploaded to a specific wound (e.g., "Left Leg") correctly update the evolution chart for that wound only.
- Language Support: Verify UI translations and date formats for Spanish, Italian, and English.
- Dashboard Metrics: Validate that doctor's dashboard correctly aggregates data from their assigned cohort.
Status and Follow-up Checkpoint
| Task | Status | Expected Date | Final Date | Comments |
|---|---|---|---|---|
| ✍️ Written | ✅ Done | 2026-03-02 | 2026-03-02 | Technical specification documented |
| 💬 Discussed in Meeting | ⏳ Pending | TBD | - | Scheduled for kickoff meeting |
| 📋 Reviewed by CTO | ⏳ Pending | TBD | - | Awaiting technical architecture review |
| ✅ Approved by CTO | ⏳ Pending | TBD | - | Final approval required before development |
URL/Domain configuration
- URL:
clinicaltrial.legit.health - Details: Standard URL will be used. No custom domain will be implemented.