Quality Management

Quality Management

Klinar 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 QC unit. High quality is maintained throughout the trials by means of;

 

  • SOP compliance
  • Co-monitoring / internal audit visits
  • Project related document (both electronic and hard copy) controls
  • Clinical trial supplies accountability
  • Ensuring availability of essential documents
  • Maintenance of archiving system
  • SOP trainings (both company and sponsor SOPs 
 

There are three levels of quality control systems established in Klinar 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.

Klinar 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

Klinar 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.

 

Klinar CRO is Certified for ISO:27001 Information Security Certificate

 
Current Klinar CRO SOPs are:
 
  • SOP on General Features of SOPs
  • Safety Reporting SOP
  • Patient Information Sheet /
    Informed Consent Form Preparation and Procedures SOP
  • Non drug Supplies Management SOP
  • Handling of Suspected Fraud in Clinical Trials SOP
  • Protocol Writing SOP
  • Medical Writing SOP
  • Translation SOP
  • Computer SOP
  • Company Task Management SOP
  • Archive SOP
  • Audit Inspection Preparation SOP
  • Site Selection SOP
  • Monitoring Visit SOP
  • Investigational Product Management SOP
  • Data Management SOP
  • CRF Design SOP
  • Ethics Committee Submission SOP
  • Patient Recruitment and Retention SOP
  • Collaborating with Partners SOP
  • Meeting Organization SOP
  • Emergency Management &Disaster Recovery SOP
  • Quality Control and Assurance SOP
  • Documentation SOP
  • Training SOP
  • Site Management Organization SOP
  • Laboratory and Medical Center Organization SOP
  • Post-Marketing Surveillance Studies SOP
  • Project Management SOP
  • Database Life Cycle SOP
  • Electronic Data Capture SOP
  • Import Licence and Customs Clearance Procedures SOP
  • Risk Management SOP
  • Corrective and Preventive Action Plan
  • Product and Patient Tracking Systems SOP