Optimum-cro :: Optimum Contract Research Organization

Opening Hours : Monday to Friday - 09am to 6pm
  Contact : (+90) (312) 231 76 46

Overview

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)

siringali-ilaclar

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

quality_control

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.

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