Klinar QMS

PRIVATE SOLUTIONS

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 supervisors coordinators 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 QMS will include all the quality related materials to comply with the below levels of the quality control and assurance including our 35 effective SOPs as follows:

  • 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

The Best Outsourcing Solution!

Full service CRO with Customer-Oriented project management and proposals

Excellent expertise with more than 350 completed projects.

High level of customer satisfaction with dedicated team work and synergy.

Clear strategies for your projects starting from the beginning.

Project and staff stability.

Quick start-up timelines with good communication to the ECs and RA.

Flexible, proactive, professional teamwork.

Competitive costs, Efficient processes

Open communication to our clients and employees

Good risk mitigation processes and planned business continuinity

Quality Certificates such as MoH GCP Certificate, ISO:27001 Information Security Management.

Micromanagement on project and site performence.

High patient recruitment level and efficient patient retention policies.

Recruitment strategies for targeted populations.