Creating a scientific research analysis of the relationship between the subjects in clinical trials, aiming to optimize the connections between subjects and the carried clinical trials.

The enterpreneur's idea aims to create a system for carrying out scientific research analysis of the relationship between the participants in clinical trials. As a result they will be optimized. The project's name is 'Trial Analytica'. Clinical trials are a notion which describes the scientific and research activity in the process of development of new drugs. This process begins with computer simulations and lab tests, used to synthesize a few thousand proper molecules. They are all then registered as patents and the 20-year patent term begins from this moment - article 16 from the Law for patents and utility models. In order to be approved and sold on the market a drug must be proven effective (able to cure) and safe (non-toxic). Effectivity and safeness can be proven in terms of mandatory tests. The data from these tests is accompanying the form for drug approval - article 27, paragraph 1, point 10 from the Law for drug products in humane medicine. The scientific research system 'Trial Analytica' will gather all participants in order to overcome the functional limits of the acquired data. This data won't be acquired only from or for one participant, but will serve the needs of them all. For the first time pharmaceutical organizations-sponsors, CRO, clinics, investigators, patients and volunteers are able to input standardized data in an online platform and gain access to gathered information, which can be surveyed in real-time. This way we can go out of the mediator communication (Sponsor-CRO-Center-Patient), which happens only in terms of a clinical trial. On the contrary, the sponsors won't rely only on CROs to give them information for the disposition of the centers and of the patients, and CROs will not be void of direct access to the patients' opinions.

Comments