(Coming soon)

 

  • 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)

(https://fmapps.emea.europa.eu/SME/search_results2.php?CompanyName=nextraresearch&CompanyActivity=&Country=&search_submit=Search )

 

 

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”

 

APPLICATION FORM > LINK

 

*from : http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp&mid=WC0b01ac05808768df

 

NEXTRARESEARCH SRL

Registered Office: Via Lorenzo Respighi, 7 - 00197 - Roma - Italy //  Ph.  (+39) 02 89950695 - Fax (+39) 06 92932362 - Fiscal Code/VAT nr. 14033291007

Contacts: regulatory@nextraresearch.eu -  info@nextraresearch.eu - nextraresearch@pec.it