Contract Research Organization
ARGEFAR Contract Research Organization (SAK) Management Unit provides the following services for researches that are planned to be conducted independently in ARGEFAR Clinics or any other center:
Center selection, center feasibility assessment;
In order to carry out the research in accordance with the Good Clinical Practices, Helsinki Declaration and other legislation, the selection of centers / centers and Researcher / Researchers with a physically appropriate infrastructure and appropriate number of healthy / patient volunteers to use the research product are made.
Designing for Bioavailability - Bioequivalence Research;
Information about the product to be extracted is reviewed, scientific articles, legislation and guidelines issued by national and international legal authorities are examined and designs are made in order to select the optimal number of volunteers.
Designing with researchers for phase research, observational research and other clinical research
Preparation of Ethics Committee & Ministry of Health application dossier and annexes;
The application file and all annexes required to be submitted to both the Ethics Committee and the Ministry of Health in accordance with the relevant guidelines and legislation are prepared and applied. In addition, all necessary correspondence processes are managed during and after the application.
Accurate and complete preparation of basic documents of clinical trials;
Research Protocol, Informed Voluntary Consent Form (BGOF) and Case Report Form (ORF) design;
The Research Protocol, the most basic document of clinical research, and the BGOF and ORF required to be prepared in accordance with this protocol, are prepared in accordance with the Good Clinical Practice guidelines for single-center / multi-center studies.
Monitoring is defined in the Guidelines for Good Clinical Practice as esi monitoring progress in clinical research and ensuring that clinical research is conducted in accordance with the research protocol, standard working methods (SOP), good clinical practice, and relevant legislation ”. In this respect, monitoring activities are carried out by the Monitor team in line with the izasyon Monitoring Plan hazırlanmış prepared in accordance with the research design.