Patient Enrollment Starts 10.5 Weeks After Submission of Documents to Regulatory AuthoritiesOCT team has started patient enrollment for the Phase III trial of a drug for male erectile dysfunction. It took only 10.5 weeks for the first patient to be included after the primary submission of documents to regulatory authorities.
«Usually it takes 14-18 weeks in European countries to get the FPI after the submission of documents to obtain approval for a clinical trial, – notes Irina Petrova, OCT Clinical Operations Director. – By involving Bulgaria in the study, we ensured the project start in just 2.5 months».
The study participants include over 700 male patients, ages 18 to 70, who will be enrolled by investigation sites in Bulgaria, Russia, Latvia and Ukraine. In this project OCT is responsible for all major activities including regulatory support, sites selection, logistics, project management and monitoring.
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