Electronic Patient Reported Outcome (ePRO) Gains Momentum in Clinical Trials

Electronic Patient Reported Outcome (ePRO) Gains Momentum in Clinical Trials


Patient-reported outcome (PRO) refers to a health outcome directly based on patient self-reporting. While some measures can be captured during site visits, others may be tracked more efficiently close to real-time.

Health care professionals have commonly used paper-based data collection methods to collect PROs, but as technology advances, pharma companies are transitioning away from this and moving to electronic patient-reported outcomes (ePROs). ePROs allow easy technological access to the study participants ensuring that regular and real-time feedback is recorded on their health status and response to treatments. The use of ePROs facilitates the robust analysis and reporting of PRO data, contributing to the  high scalability as well as cost efficiency of clinical trials. 

Such electronic systems offer added capabilities, such as easy quantification of individual symptoms and tracking of patient surveys for trend analysis over time. It further improves patient engagement, patient outcomes (e.g. Quality of Life, QOL) and efficiency due to the reduced visits to the study site, which is key for delivering patient-centred care.

SCARLETRED is a digital health company that provides a novel solution for the standardized documentation, assessment, quantification, and analysis of conditions ranging from dermatological indications to drug reactions to fungal conditions. 

Scarletred®Vision is the CE certified Class I Medical Device developed by SCARLETRED. The system is ICH-GCP, GDPR- and HIPAA-compliant and is a certified ISO-13485 Quality Management System. It is used in a wide variety of settings, including clinical trials (preclinical to phase IV), routine clinical work, hospital care as well as remote monitoring of patients. Scarletred®Vision’s scalability allows doctors to easily empower their subjects to participate and provide valuable data from the comfort of their home. 

How does Scarletred®Vision work?

Scarletred®Vision consists of the following components:

Mobile App: generation of high-quality images in conformity with data protection regulations and patient anonymity

Skin Patches: calibration of the captured images for color, lighting conditions, and size

Online Platform: documentation, assessment, and quantification of patient data

Scarletred® Mobile App: Imaging & ePRO 

Step 1: Place the Skin Patch on the healthy skin next to the area of interest.

Step 2: Take an image using the Mobile App, which is then automatically uploaded to the secure online platform.

Step 3: The analysis can be performed on the Online Platform, which offers multiple tools to assist medical professionals.

Step 4 (optional): ePRO can be customized and configured to appear after the image has been taken (Figure 1). The answers and the resulting score are documented centrally on the platform together with the subject´s image. 

DLQI questionnaire in the Scarletered Vision mobile app
DLQI questionnaire in the Scarletered Vision mobile app
DLQI questionnaire in the Scarletered Vision mobile app
Figure 1. Scarletred®Vision in-App ePRO: The software can be configured to have customized questions appear automatically at the interval of choice. In this example, the Dermatology Life Quality Index (DLQI) has been configured to automatically appear after an image of the area to be investigated has been captured. Here, the resulting score, which is based on the user’s input, corresponds to the subject’s health related Quality of Life.

The image, taken with the mobile app, is automatically uploaded to the online platform where it can be visualized. The technology displays the image in four signal maps, each one highlighting a specific parameter: Standard Erythema Value (SEV*), redness (a*), yellowness (b*), and lightness (L*). In addition, the previously filled ePROs by patients are documented and can be viewed on the online platform, providing further insights into the patients' QOL, vital signs, and enables the real-time tracking of symptoms (Figure 2).

Documentation of AOI and questionnaire data entered by a psoriasis patient on ScarletredVision platform
Figure 2. Scarletred®Vision Online Platform: Documentation of the area of interest and weekly questionnaire data entered by a psoriasis patient. The signal intensity (SEV+), along with other parameters, of the taken image can be customized, allowing for a more meaningful analysis. In addition, the data entered by the patient previously for the Dermatology Life Quality Index (DLQI) can be viewed by medical professionals/CROs.

Scarletred®Vision’s innovative approach to creating digital solutions is the first of its kind. Its modular framework makes it applicable to all skin conditions (dermatological diseases, injection sites, drug reactions, allergic reactions, cosmeceuticals and many more). The certified Medical Device offers digital documentation and analytical tools that have been proven, both in the clinical and home-based settings, to increase data quality, enable doctors to quantify visual parameters, to improve patient treatment regimen and patient compliance, save doctors time, and generate analyses that are not obtainable with other technologies in the field.

Don’t be a stranger!  Get in touch with our Team so that we can discuss how to best tailor our solution to fit your needs: support@scarletred.com.

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