Injection site reactions (ISRs) are a constellation of symptoms, such as erythema, swelling, pain, and induration, occurring at the site of the injection. Documenting and monitoring ISRs are integral components of the clinical trial process for any injectable drug or treatment. During clinical development, local reactions at the injection site must be tracked to complete the safety assessment of the investigational product. ISRs can occur right after the substance has been administered and subsequently evolve over time after the individual has left the health care provider, highlighting the need for a solution that can accommodate real-time, remote, home-based monitoring. Medical professionals agree that traditional methods of ISR monitoring in the product development phases are lacking, leading to a loss of time, precision, and data. The global digitalization trend and the impact of the current SARS-CoV-2 pandemic are the main driving forces behind the development of new injectables, revealing the urgent requirement for novel state-of-the-art tools that can be more efficiently implemented. In the present global market and research study, we (SCARLETRED) give an overview of the applicable industries and our technological solution, Scarletred®Vision, which outperforms conventional methods and is on its way to becoming the modern standard for remote ISR Monitoring and objective quantification in a broad range of application fields.

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