Scarletred®Vision
Components
Scarletred®Vision
Skin Patch
Our patented Scarletred®Vision Skin Patch is automatically detected by the Scarletred®Vision App and allows normalizing captured skin images by color and size in a GCP compliant process. The biocompatible adhesive film allows mounting of the patch even on very sensitive skin.
Scarletred®Vision
Mobile App
The app is developed and tested in clinical trials with medical experts and allows to convert a GCP compliant process in your clinical trial and medical routine applications. Upon request we offer a 100% controlled remote service in which we supply the latest iPhone models with the Scarletred®Vision App pre-installed to the client directly. This includes a remote managed service.
eCOA - Electronic clinical outcome assessment
Record and connect primary and secondary clinical outcomes with
objective imaging and AI-derived analysis
outcome assessments
Scarletred®Vision is a state-of-the-art electronic data capture system integrating electronic Clinical Outcome Assessment (eCOA) directly with standardized clinical imaging, quantitative image analysis, and optional AI-based assessment modules within a certified digital infrastructure.
This enables sponsors to collect and connect primary and secondary clinical outcome data with objective imaging information and AI-derived scores within one integrated clinical trial infrastructure. Patient-reported outcomes, investigator assessments, standardized images, and quantitative image-derived parameters can be aligned by patient, visit, and study time point, creating a comprehensive longitudinal dataset designed to support the assessment of treatment safety and efficacy.
Whether data are collected at the clinical site (eClinRO), by an observer or caregiver (eObsRO) or by the patient itself (ePRO) Scarletred®Vision brings subjective clinical outcomes and objective visual evidence together within a single coordinated workflow.
Why pharma and dermatology experts choose Scarletred®Vision?
One integrated clinical workflow
eCOA/ePRO questionnaires are triggered automatically as integrated pre- or post-imaging steps.Patients and site teams collect clinical outcome assessments and standardized imaging data within the same application, reducing workflow fragmentation, eliminating unnecessary app switching, and simplifying study participation.
Connect outcomes with imaging and AI
Go beyond collecting individual data points. Scarletred®Vision enables sponsors to directly relate patient-reported outcomes and clinical assessments to standardized images, quantitative imaging parameters, and AI-derived scores collected at the corresponding study time point. This provides a richer basis for understanding how subjective symptoms, investigator assessments, and objectively measurable skin changes evolve together over time.
Intelligent reminders
Automated push notifications can be configured independently for patients and site personnel and aligned with protocol-defined assessment windows.Targeted reminders support timely completion of scheduled imaging, eCOA / ePRO activities across individual study visits and time points.
Standardized or fully customizable
Deploy established clinical outcome assessments or configure questionnaires according to the specific requirements of your study protocol.Cohort-specific: Questionnaires according to predefined cohort characteristics.Time-point-specific: Assessments according to individual visits and study time points.Flexible response formats: Capture structured responses, multiple-choice selections, conditional branching logic, and free-text entries.
Offline-first with smart synchronization
Reliable data collection should not depend on continuous internet connectivity, this is why Scarletred®Vision supports eCOA and ePRO data capture even when an internet connection is temporarily unavailable without losing time stamp synchronization. Data are securely stored on the device and automatically synchronized with Scarletred infrastructure once connectivity is restored, supporting continuous data capture across clinical sites and remote-study environments.
Designed for every study model
On-site clinical trials
Capture investigator assessments, patient-reported outcomes, and standardized clinical images during site visits within one integrated workflow.
Decentralized & hybrid clinical trials
Enable patients to capture standardized clinical images and complete ePRO assessments remotely from home while maintaining a consistent study workflow.
Real-world evidence
Extend standardized outcome and imaging data collection beyond conventional clinical trials to support long-term, longitudinal Real-World Evidence (RWE) studies across geographically distributed patient populations.
Regulatory-grade infrastructure
Medical device framework
The Scarletred®Vision system is clinically validated and CE-certified as Software as a Medical Device (SaMD), providing a regulatory-grade framework for standardized clinical imaging, electronic data collection and analysis.
Data privacy & information security
SCARLETRED’s infrastructure is designed to support regulated clinical research environments and applicable requirements including ICH-GCP, GDPR, and HIPAA. SCARLETRED’s information security management system is certified according to ISO/IEC 27001:2022, providing an internationally recognized framework for information security, data protection, and governance.
Scarletred® Vision
Worldwide available
+25
YEARS OF EXPERIENCE
128
COUNTRIES
>20
INTERNATIONAL AWARDS
Precision at every step
Advanced tools designed to support your expertise and ensure compliant data management.
Projects Overview
Select your assigned project
Patients Overview
List of all previously created patients for this Project
Scan a QR-Code
Create a new subject in the App by scanning their unique QR-Code
Place the Skin Patch
Next to the area of interest for light and color calibration purposes
Take an Image
Save, retake, or take additional images
Add a Body Tag
Tag the imaged body part
Questionnaires
Can be configured according to clinical requirements
Image Overview
List of a subject's images
Planimetrics
Draw the area(s) of interest for a detailed analysis
Scarletred®Vision
Online Platform
It is an online-enabled dermatological imaging platform for image data management and analysis, and the main component of the medical device. Previously generated dermatological images can be transferred to the Scarletred®Online platform REMOTELY from the Scarletred®Mobile app.
Working with Scarletred®Vision is very cost efficient. Automation of time and error prone process steps lead to 90% cost reduction
We enable remote monitoring and analysis which leads to two times higher patient compliance.
Standardization of skin imaging and scoring with Scarletred®Vision leads to superior data quality.
Scarletred®Vision can be used in a broad range of dermatological applications
Subscription ensures that your tools are up to date and reduces your infrastructure cost
QR and trial codes increase data safety and automate data allocation
System Requirements
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