Clinical trials (CT) are crucial to improving drug development and safe lives worldwide. However, it takes an average of 8 years and $100m to complete and is a critical component in drug development (total cost of $2.6 billion and a time to market of 12 years). Relevant to this proposal, some of the reasons that cause CTs to have high costs and lengthy time frames for Study Sponsors are ineffective monitoring, weak quality control measures, poor data management, and lack of reporting tools. Among all phases, on average, these challenges amount to approximately 45-50% of the costs. Due to these high costs and long durations, ~12% of drugs are not developed. Furthermore, traditional methods for evaluating the evolution of the symptoms produce data that is episodic, subjective, and scarce, meaning that patients, clinicians, and other stakeholders do not have needed evidence to make real-world decisions. Also, the obligation for patients to be physically in the hospital/clinic to perform the evaluations supposes an inconvenience and is a time-consuming activity for both parts estimated at 12 hours per week per patient. This ineffective monitoring, weak quality control measures, poor data management, and lack of reporting tools causes clinical trials (CTs) to be lengthy and costly processes.
Benefits society by saving time to doctors from administrative work and thus, being able to spend more time attending patients, increasing the quality of the treatment and diagnostic; also, it prevents relapses of chronic patients; and, helps to research drugs in real environments (RWD).
Our ambition is to be the best company for remotely monitoring the health of patients or the overall population using their own devices or disease-specific devices. With the grant and the coaching of the SME phase I, we intend to perform 1) market study; 2) regulatory analysis; 3) business plan. As part of our ambition, in 4 years, we will work towards entering the clinical Value-Based Healthcare market too (€2.4bn 30% job increase) with the aim to improve patients’ health outcomes by providing a better follow-up.
