The current COVID-19 pandemics forced many clinical trials using human subjects to grind to a halt, stalling research until the situation is resolved. However, on the other side, this unfortunate time provides Biopharma industry with a unique window of opportunity to further develop and test their investigational medicinal products in a broader preclinical setting as well as it gives Sponsors and CROs more time and room for innovation, aiming to find alternative and more efficient ways of planning and conducting a study, such as carrying out research for toxicological and safety assessments in vivo, prior to that in human subjects. Hence, in these challenging days an increasing demand for state-of-the-art digital technologies combined with a faster adoption rate of novel methods can be observed in biopharma as well as in the global health care market in general. Going virtual is seen as an overall key to success and certified digital technologies, like Scarletred®Vision, thus get significant momentum. This new situation accelerates digitalization also in fields where regulations are strict and will change the game in preclinical and clinical trials not just for now, but in the long term.
Scarletred®Vision is a state-of-the-art and medical device certified software platform technology designed to standardize skin documentation and visual assessment in dermatology. It ensures standardized imaging, objective documentation and quantitative measurement of visible skin changes and lesions with a wide range of use in dermatologic research and clinical routine.
Using the platform for in vivo preclinical research, toxicological and safety testing can minimize human involvement, in compliance with the restrictions present during the course of the COVID-19 pandemics. Scarletred®Vision´s technology automatically standardizes the acquired images, thus overcoming inaccuracies resulting from the subjectivity of conventional diagnostic methods. It includes a user friendly, secured interface, along with skin patches, which can be easily applied even on sensitive skin types. The app, available for iOS, together with the platform, accessible from all current browsers, create a secure data storage and information flow between patient and physician and/or other authorized professionals, such as CROs. The real-time based objective visual documentation of the skin changes and lesions grants improved monitoring of the manifestation of dermatological disorders.
Every new potential medicinal product or drug has to go through the different phases of research and development, strictly in compliance with regulations. Due to the broad range of applications offered by the GCP grade and ISO13485 certified technology of the software, it has full potential to be used in a preclinical and clinical setting without risking breaches in conformity with regulatory standards.
Scarletred®Vision is able to greatly contribute to the ultimate goal of preclinical research, to investigate the desired biological effects, to predict efficacy and to identify any potential toxicity associated with the use of the tested compound or medical product, which can predict safety issues. Even though every clinical trial has different requirements, patient groups and end points, this innovative technology offers a powerful and objective solution for the standardization of documentation and monitoring of visual changes on the skin surface. The app is connected by a secure server to the platform that serves as an analytical and documentation tool for the digital information and image documentation acquired during preclinical drug screening, as well as clinical trials, while in compliance with international regulatory and safety standards, such as GCP. Data security and anonymity is ensured by the generation of unique and personalized Scarletred®QR code. The platform provides optimized analysis of the severity of skin changes and lesions through the integrated remote data monitoring and the built-in customizable service tools.
The current shift of the development focus on preclinical toxicological testing and safety assessment in vivo offers now an alternative way to move forward with medicinal product investigation in the time of the COVID-19 pandemics. Furthermore, in its context, Scarletred delivers the potential to minimize the number of human subjects involved and create a smoother transition from preclinical to clinical research helping the development of more efficient health care products and services.