In this context, our company operates as a Contracted Research Organization (SAK). The study is completed by managing all stages of the BY-BE clinical study (ethics committee and Ministry of Health applications, clinical, analysis, statistical phase);

– Preparation of clinical trial protocol in accordance with current regulations and legislation

– Preparation, evaluation and control of the Case Report Form (ORF)

– Preparation, evaluation and control of the Informed Consent Form (BGOF)

– Preparing the complete file and applying to the Ethics Committee

– Approval of the study by applying to the Medicines and Medical Devices Agency of the Ministry of Health

– Initiation of clinical work according to the Protocol by organizing with the Clinical Center

– Realization of monitoring during the clinical study process

– Transfer of blood samples at the end of the clinical study

– Analyzing the samples in accordance with current rules and legislation by providing organization with the analysis center

– By making statistical calculations, the STUDY RESULT REPORT is completed and delivered to the sponsor pharmaceutical company.