Clinical Trial Workflow and Data Integration
This page describes the end-to-end workflow for psoriasis PASI assessment in a clinical trial, from protocol design through to EDC data delivery. The workflow supports both in-clinic and decentralised (home-based) capture.
Workflow overview
- Protocol design: Configure the study with Legit.Health
- Site setup: Deploy the platform to investigator sites
- Patient enrollment: Register patients in the platform
- Image capture: 11-perspective full-body photography (clinic or home)
- AI scoring: Automated APASI calculation
- Report review: Investigator reviews the PASI report
- Severity tracking: Longitudinal PASI evolution and response rates
- Data export: Structured delivery to EDC systems
1. Protocol design
| Configuration item | Options | Example |
|---|---|---|
| Imaging perspectives | 11-perspective full-body, 4-perspective close-ups only, custom | 11 perspectives (full-body + close-ups) |
| Endpoints | APASI (composite PASI), per-component scores, BSA, PASI 75/90/100 response | APASI + PASI 75 response (co-primary) |
| Capture mode | In-clinic, decentralised (home-based), hybrid | Decentralised for JNJ-77242113 |
| DIQA threshold | Strict (pivotal) or lenient (RWE) | Strict for Phase III |
| Data export format | API, CSV, CRF-mapped fields | CRF-mapped to sponsor’s EDC |
A study-specific investigator manual is generated for each trial. For decentralised protocols, a patient-facing manual is also generated with step-by-step capture instructions in all required languages.
2–3. Site setup and patient enrollment
The platform is deployed as a web application. For decentralised protocols, patients also download the mobile application.
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4. Image capture
Patients (or investigators) capture 11 photographs covering all four PASI body regions. The mobile application provides perspective silhouettes and real-time DIQA quality checks for each image.
Processing takes approximately ~5 seconds for 11 images combined.
5. AI scoring
The AI processes all images and computes:
- Per-region intensity scores: Erythema, desquamation, induration (0–4) per body region
- Per-region BSA: Affected area percentage via pixel-level segmentation
- Per-region PASI contribution: Weighted regional score
- Global APASI score: Composite PASI (0–72)
- DIQA quality scores: Per perspective
6–7. Report review and severity tracking
The investigator reviews the PASI breakdown per region and tracks PASI evolution over time. The platform automatically computes:
- PASI response rates: PASI 75, PASI 90, PASI 100 flags at each visit
- Absolute PASI change from baseline
- Per-region trends to identify regional treatment response
8. Data export and EDC integration
| Field | Description | Format |
|---|---|---|
| Patient identifier | Study-specific pseudonymised ID | String |
| Visit date | Date and timestamp of the assessment | ISO 8601 |
| Global APASI score | Composite PASI score (0–72) | Float |
| Per-region PASI | Regional PASI contribution for head, trunk, upper extremities, lower extremities | Float per region |
| Erythema per region | Erythema intensity score (0–4) per body region | Integer |
| Desquamation per region | Desquamation intensity score (0–4) per body region | Integer |
| Induration per region | Induration intensity score (0–4) per body region | Integer |
| BSA per region | Affected body surface area percentage per region | Float (%) |
| DIQA scores | Image quality score per perspective | Float |
| PASI response | PASI 75/90/100 response flag (percentage improvement from baseline) | Boolean per threshold |
Integration methods
- API-based: Automated data flow from the Legit.Health platform to the sponsor’s EDC system via RESTful API
- CSV export: Structured CSV files for manual import into EDC systems
- CRF field mapping: Data fields pre-mapped to the sponsor’s Case Report Form structure, configured during protocol design
- QuantifiCare platform integration: For studies using the combined QuantifiCare + Legit.Health solution, scoring data flows through QuantifiCare’s platform to the sponsor’s data management system
All exported data is structured for direct mapping to CRF fields in standard EDC systems (Medidata Rave, Veeva Vault CDMS, Oracle InForm, etc.).
The integration is API-based and system-agnostic and works with any EDC system (Medidata Rave, Oracle InForm, Veeva Vault EDC, and others). Export formats include RESTful API, CSV/Excel, structured JSON, and automated S3 transfer for large-scale data delivery. Legit.Health provides IQ/OQ validation documentation and data mapping specifications to support the sponsor's integration validation activities.
Decentralised and hybrid trial support
Hybrid designs
Some study designs combine investigator-captured and patient-captured images:
- Investigator timepoints: Primary visits (e.g., baseline, month 3, month 6, month 12) where images are captured by trained site personnel at the clinic
- Patient timepoints: Intermediate visits (e.g., monthly check-ins) where the patient captures images at home using the mobile application
The same AI scoring pipeline processes both types of images. DIQA quality control is applied identically, ensuring that patient-captured images meet the same quality standards as investigator-captured images.
Remote patient capture
For fully decentralised protocols:
- Patients download the Legit.Health mobile application
- The app guides them through the capture process with the same perspective silhouettes and DIQA quality checks used at investigator sites
- Captured images are transmitted securely to the platform for AI scoring
- The investigator can review scores remotely
Benefits for sponsors
- Reduced site burden: Fewer in-clinic visits needed for severity assessment
- Increased data frequency: More timepoints without increasing site workload
- Patient convenience: Assessments from home reduce travel burden
- Continuous monitoring: More frequent assessments enable finer-grained treatment response detection
The psoriasis 11-perspective protocol has been specifically validated for decentralised capture in the JNJ-77242113 Phase 3 trial for moderate to severe plaque psoriasis, demonstrating that patients can successfully capture standardised full-body images at home with the guidance of the Legit.Health mobile application.