Descripción del proyecto
Clinical Trials (CT) are designed to prove if a drug, device or therapy is safe and effective in the human body, so they are already tested in individuals. The CT investigators and sponsors spend great amount of resources on data management and project and data quality control. In 2017 more than 120,000 CT have been registered, of which near 31,000 are carried out in the EU. Usually the average duration of CT from start to marketing is 7.5 years, however, more than 80% of CT are delayed from 1 to 6 month costing to the companies upwards of 30,000 € per day per trial. In most of the cases, this delay is due to inefficient management systems. With CT conducted in over 140 countries, the complexity and rate of change in trials is increasing. Considering this huge business opportunity, we have been working in a customizable software system to manage and simplify CT development. iMOTED platform will ensure high quality data, collected from multiple sources by using real time analysis of data, a simple and intuitive interface, generation of real time alarms employing estimations, predictions & simulations
In this way, we expect to reduce the economic losses that pharma industry has when launching a new drug, for whom only 2 out of 10 marketed drugs return revenues that exceed R&D costs.
iMOTED belongs to the e-clinic market, which is forecasted to reach €7.6 Bn by 2022 growing at a CARG of 12.4% over the period 2017-2022. We will initially target Europe as our domestic market, to start selling the IMOTED licenses. We expect to have our breakeven point two years after the beginning of the project, a cumulative turnover of €13 M by 2022, that will give us a ROI of 560% in 2024. Hence, at this stage of development we believe that we need to perform a through feasibility study to assess for the challenges and tasks that we still must accomplish to launch iMOTED for what we are asking for EC support.