Quality Management

qa

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. Seconday level of QC is performed by project supervisors and general manager. 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 comprehensive and detailed SOPs to guide and train all staff, to ensure operations to be carried out in compliance with ICH/GCP and regulations to fulfill the sponsor companies’ requests and requirements.
 
 
Klinar CRO quality managers have prepared and approved the SOPs in compliance with ICH/GCP and the new bylaw published in Turkey at the end of 2008.
 
 
In addition, in Klinar CRO‘s project management system, it is always possible to work with sponsor companies’ SOPs.
 
 
Current Klinar CRO SOPs are:
 
  • SOP on General Features of SOPs
  • Patient Information Sheet / Informed Consent Form Preparation and Procedures SOP
  • Safety Reporting SOP
  • CRF Design SOP
  • Audit Inspection Preparation SOP
  • Investigational Product Management SOP
  • Quality Control and Assurance SOP
  • Non drug Supplies Management SOP
  • Company Task Management SOP
  • Protocol Writing SOP
  • Translation SOP
  • Meeting Organization SOP
  • Documentation SOP
  • Ethics Committee Submission SOP
  • Project Management SOP
  • Monitoring Visit SOP
  • Data Management SOP
  • Database Life Cycle SOP
  • Electronic Data Capture SOP 
  • Training SOP
  • Collaborating with partners SOP
  • Patient Recruitment and Retention SOP
  • Computer SOP
  • Handling of Suspected Fraud in Clinical Trials SOP
  • Archive SOP
  • Medical Writing SOP
  • Emergency Management & Disaster Recovery SOP
  • Site Management Organization SOP
  • Laboratory and Medical Center Organization SOP
  • Post-Marketing Surveillance Studies SOP
  • Site Selection SOP