Conduct of a pre-CE investigational device trial in Macedonia

Start-up activities for this client, Japanese Medical Devices company, occurred during Months February- March 2011.  Close cooperation with R&D ensured smooth initiation of the site selected, Skopje in Macedonia.  Approval from Competent Authority and Ethics Committee was obtained within 1 Month after submission. During the Month June 2011 all subjects were recruited (renal care) and data base lock as planned in August.  Lyncoclinical was responsible for protocol writing, submission, initiation and monitoring of the site.  Currently ICTR is in preparation.