IP protection




Please provide a short description of the state-of-the-art and/or current trends in the field? How does the result fit into it?
The Clinical Trials, when related to pharmaceutical products, are driven by the pharmaceutical companies. Statistics from the trials are performed by the company which is providing the pharmaceutical product and all the operational issues are supported by the hospital. To have the knowledge of what’s is going on and what are the results of the trials, the clinic personnel has to be involved on both scientific and administrative sides. Usually, there are no standard procedures to be applied or, even if they are standardized, they require a lot of human effort to be followed. The proposed software tries to make an automated approach to record, analyze, and report information about all Clinical Trials that reduces the operating costs.






What is the problem/need/knowledge gap that the research result is responding to?  How was it addressed before?
The research result is addressing the need to have a time efficient (and consequently cost efficient) way to record, analyze, and report clinical and financial information about all Clinical Trials conducted. The software uses very popular and well known blocks (Microsoft Access, MySQL, etc.) that allow a simple deployment in every clinical context. The value of the tool is related to the structure in terms of data requested by the client forms, the database structure and by the reporting capabilities in addition to the deployment simplicity. The software has been build on the base of the real experience in the field of clinical trials.

In the past, the procedures were based on some spreadsheets and manual reporting not suitable to the need of manipulating big quantities of data in a fast way.







What is the potential for further research?
The main goal of the research result is to help institutes to efficiently record, analyze, and report clinical and financial information about all Clinical Trials conducted. The software let the user make some customization and, excluding bug fixing, the development is to be considered closed.






What is the proposed method of IPR-protection? (patent, license, trademark etc.)
At the moment, the only envisaged method is the copyright. The development of a commercial product may be arranged in the frame of a partnership with an external software house. In that case the know-how will be licensed.







What are the steps that need to be taken in order to secure the IPR-protection? What is the cost of IPR-protection?
Copyright protection by the registration of the software on the Public Register for computer programs has a cost starting from 120 €.

A similar level of protection can be made by the researcher by sending the software description and the software itself on a CD in a closed envelop by certified mail to himself. The stamp certifies the date of release of the software and can be used against claims of originality or to claim originality.







What is you overall assessment of the scientific maturity of the research result?
The result is ready to be deployed in it’s current version. Some issues about the product/service business model have to be still considered. A further possible step concerns usability issues. The software goal was to make the pharmaceutical clinical trials more controllable and it was focused on the Ethic Committee activities. Since the structure of the software is general, synergies may arise trying to apply the software in other fields of clinical trials.







Please put X as appropriate. 1 2 3 4 5
Scientific maturity       X  
Synergies       X  
State-of-the-art/innovation     X    
IPR-potential     X    




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