OPTIMUM CRO has its self-check systems to provide improvement and control of quality in management of clinical studies. These systems consist of regular internal checks which are performed by separate QC unit. High quality is maintained throughout the trials by means of:
•SOP compliance checks
•Co-monitoring/internal audit visits
•Project related document (both electronic and hard copy) controls
•Clinical trial supplies accountability
•Ensuring availability of essential documents
•Maintenanceof archiving system
•SOP trainings (both company and sponsor SOPs)
There are three levels of quality control systems established in Optimum CRO. Primary Level of QC is performed by related CRA, project manager, data manager, PMS manager and office manager, secondary level of QC is performed by project supervisorscoordinators and general managers and tertiary Level of QC is performed by quality managers.
Quality Assurance is also performed in many aspects including general management activities, fulfillment of contract requirements, inspection and corrective/preventive actions.
Optimum CRO has succesfully completed ;
* Eight site audits performed by representatives of the sponsor company’ s quality department
* Ten system audits performed by representatives of the sponsor company’ s quality department
Optimum CRO has completed many site audits and also some system audits performed by representatives of the sponsor companies’ quality departments. All of these audits were completed successfully.