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Legit.Health · Clinical Trials

Global Services Overview

End-to-End AI Ecosystem for Clinical Trials

Legit.Health digitalises clinical trials through an AI-driven SaaS platform that automates severity scoring and sign extraction, supported by secure data transfer and professional investigator services.

Architecture

Three-Layer Ecosystem

From image capture to data delivery, every step is designed for clinical-grade quality, regulatory compliance, and operational efficiency.

Layer 01

The Capture Layer

SaaS Platform

Standardising Data at the Source

A secure SaaS environment for investigator sites to manage subject enrollment and roles while ensuring protocol compliance through real-time administrative oversight and comprehensive investigator support.

Layer 02

The Intelligence Layer

AI Analysis

Turning Pixels into Objective Endpoints

Six specialised AI modules work together to validate image quality, segment anatomical regions, and compute severity scores automatically — eliminating manual reviewer burden and inter-observer variability.

Layer 03

The Control Layer

Services

Governance, Compliance & Oversight

A comprehensive service layer ensuring regulatory compliance, data privacy, and operational visibility throughout the trial lifecycle — from anonymisation pipelines to sponsor dashboards and investigator support.

Layer 01

The Capture Layer

Standardising Data at the Source

The Capture Layer provides a secure SaaS environment for investigator sites to manage subject enrollment and roles while ensuring protocol compliance through real-time administrative oversight and comprehensive investigator support.

Centralised Site & Subject Management

🏢

Site Administration & Governance

Centralised control over site configuration, user management, and protocol settings.

🔐

Enterprise-Grade Security

End-to-end encryption, audit trails, and compliance with 21 CFR Part 11.

👥

Role-Based Access Control (RBAC)

Granular permissions for administrators, coordinators, and investigators.

🏥

Site-Specific Management

Configure each site independently with custom settings and user assignments.

🌐

Multi-Language Support

Full UI localisation across 14 languages for global trial deployment.

Subject Lifecycle Management

Subject Creation

Streamlined enrollment workflow with automatic activation emails and credential generation.

📅

Visit Tracking

Personalised schedules anchored to enrollment date with automatic window calculations.

📊

Status Monitoring

Real-time visibility into subject progress, upload history, and compliance status.

⚠️

Protocol Deviation Notifications

Automated alerts for missed timepoints, late uploads, and non-compliant captures.

Investigator Support & Compliance

Protocol Adherence

Step-by-step guidance ensures subjects or site staff follow capture protocols consistently.

📖

The Investigator Manual

Versioned, multilingual web manual with screenshots and detailed instructions.

🔍

Automatic Image Quality Check

AI validates focus, lighting, and framing in real time before upload.

📍

Available Pose Detection

Position quality control in order to ensure standardised perspectives image capture.

Layer 02

The Intelligence Layer

Turning Pixels into Objective Endpoints

Six specialised AI modules validate image quality, segment anatomical regions, and compute severity scores — eliminating manual burden and inter-observer variability.

🔍

Dermatology Image Quality Assessment (DIQA)

Validates clinical utility of each image based on focus, lighting, framing, and anatomical coverage.

Body Surface Area (BSA) Pose Validation

Confirms captured images belong to expected anatomical domains (scalp, face, trunk, etc.).

Available upon request
🧍

Body Surface Segmentation

Identifies and segments body regions for consistent BSA calculations across visits.

Available upon request
🎯

Skin Surface Segmentation

Isolates skin surface from background and clothing for precise lesion localisation.

Available upon request
🔬

Lesion Segmentation

Delineates lesion boundaries at pixel-level accuracy to compute area, colour, and texture metrics.

📊

Automatic Score Computation

AI fills in PASI, SCORAD, SALT, and other indices automatically — no manual calculation required.

Layer 03

The Control Layer

Governance, Compliance & Oversight

A comprehensive service layer ensuring regulatory compliance, data privacy, and operational visibility throughout the trial lifecycle.

🔒

Pre-transfer Anonymisation

All identifiers stripped and images anonymised before leaving the platform.

🖼️

Background Blur & Facial Redaction

AI removes environmental context, obscures eyes/mouth, and redacts tattoos.

📋

Data Transfer Agreement (DTA)

Formal contractual framework governing data handling, retention, and transfer protocols.

📈

CRO/Sponsor Dashboard

Real-time dashboard with enrollment metrics, compliance rates, and deviation tracking.

📧

Deviation Digest Emails

Automated notifications to site staff listing subjects with missed or late timepoints.

📖

Multilingual Investigator Manual

Versioned web manual with screenshots and instructions, translated into 14 languages.

End-to-End Flow

From Capture to Delivery

Every image follows a standardised pipeline from initial capture through AI analysis to secure, anonymised data delivery.

📷

Image Capture

Subject or site staff captures images via mobile/web app

Quality Validation

DIQA module validates focus, lighting, and framing in real time

🧠

AI Analysis

Segmentation and scoring modules extract clinical endpoints

🔒

Anonymisation

Background blur, facial redaction, and metadata stripping

📁

Data Transfer

Structured exports (CSV/JSON) delivered per DTA schedule

Ready to Integrate AI into Your Trial?

Contact our team to configure your study — conditions, scoring systems, locales, and data transfer schedules.

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