Implementation of automated innovative method to collect and manage data on clinical trials in medicine

Comac Medical is a research organization that conducts clinical research, monitoring , research and testing of new medicinal products in accordance with ICH requirements of the Association for Good Clinical Practice, applicable directives of the European Parliament and the European Council, as well as all national regulations. This project proposal envisages the realization of high-tech integrated system for the collection, management and analysis of clinical data electronically through biometric devices for research. The realization of the utility model registration №BG2172U1, inherently falls into the category of production / process innovation and represents a novelty in the global and European markets as superior to all available alternatives at the time. Developed an integrated system for the collection, management and analysis of clinical data electronically's own development company and falls within the scope of the thematic areas of ISIS - industry healthy living and biotechnology, and in particular priority axis "personalized medicine, diagnostics and individual therapy, medical and pharmaceutical forms and means. " By introducing innovative method will achieve automation in the assembly phase and introducing the indicators which will speed up the processing of the results, and will also improve the accuracy of research. The automation will be achieved through the introduction of biometric devices for research by which remotely and automatically generate the results in the database. The benefits of the project will be for the contracting of research, namely pharmaceutical companies and will be expressed towards obtaining research and testing significantly shorter time and with greater accuracy and purity of the final result, which is particularly important in the specifics of the company's operations.

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Overview

Status Closed (completion date)
Start date 18 Jan, 2017
End date 05 Apr, 2018
Contract date 18 Jan, 2017
View in UMIS

Financial information

Total cost 1,641,300.00
Grant 995,670.00
Self finance 645,630.00
Total paid 992,205.00
EU participation percent 85.0%

Location