- Development of strategies and guidelines based on statistical support for the continuous implementation of clinical trials, phases I-III, of observational studies and studies related to the development of medical devices in Italy and in the European Union.
- Evaluation, before departure of the study, the feasibility of the same for each center selected for the clinical program
- Statistical analysis performed by agencies or professionals with decades of experience
- Management of the integrated monitoring
- Reporting and review of studies according to the strategies drug registration (Section Special Projects).
- Evaluation of economic evidence and flexibility to regulatory requests local market demands as the launch of a new drug or a new medical device implies a deep knowledge of market dynamics, in terms of regulations / national and local regulations.
- Support to the customer through the realization of questionnaires, the identification of a comparator treatment, the design of a clinical project, the realization of data collection as a function of a prospective or retrospective research, the use of dedicated software for the collection data and subsequent clinical evaluation, until the publication of data resulting from the study.
NextraResearch is a micro enterprise, qualified by the SME Register - European Medicine Agency (EMA)
The development remains aligned to the schedule that enables the EU Clinical TrialRegulation to come into application in the second half of 2019. (*)
Figure 1. From “25 March 2015 EMA/42176/2014 Rev. 1, Corr.* Compliance and Inspections”
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