Periodic Reporting for period 1 - CLINICOVERY (CLINICOVERY, a versatile, high quality, environmental-friendly, easy to use e-Clinical solution for clinical research)
Reporting period: 2018-04-01 to 2018-07-31
The biomedical research is the key to reduce disease burden and yields economic returns both through improved health gains (a healthy workforce) and through commercial exploitation of research outputs. The increasing disease burden has propelled the pharmaceutical industry to bring up new chemical entities into the market at a higher rate, increasing the number of clinical trials and generating huge quantum of clinical data. As a result, clinical trials are becoming increasingly complex, due the use of multiple data capture modalities (paper and pencil or/and Electronic Data Capture systems (EDC)), which require long implementation time, maintenance, upgrades and high economic investment, the need to evaluate more study endpoints and regulatory compliance with Medical Agencies and the growing number of stakeholders participating in the study.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
We have developed a feasibility study for 4 months, focusing on: Technically, we have identified the key technical requirements to integrate all the systems in the platform, identify the technical needs to integrate the selected sensors for collecting physiological data from patients and we have defined and selected the final number of templates of the eCRF and ePRO for the final version of CLINICOVERY. We have also prepared a complete Execution Plan for the development of CLINICOVERY technology, including planning, organization, risk analysis and budget. Commercially, we have assessed the targeted markets, including the competition, to prepare our marketing strategy and define the optimum business model. Regarding economic aspects, we have defined the revenue model and drafted financial forecasts for the first 5 years, based on the marketing and price policy.
Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)
CLINICOVERY is a versatile, customizable, environmentally-friendly, regulatory compliant, easy to use technological multi-platform to collect, manage and analyse clinical trial data using smartphones, tablets and PCs. It will eliminate the use of paper and reduce the clinical site workload (60%) and implementation costs (between 78% and 88%). It is the unique eClinical solution that has implemented blockchain technology and wearables to collect physiological data from the patients. CLINICOVERY project will also enable our company to grow, both financially- achieving revenues of approx. €13.1 million and profits of €7.2. million in 2025- and in personnel- we will hire 31 more people.