Quality Assurance

 Quality assurance (QA): the systematic and independent examination of all clinical trial-related activities and documents.
 We are concerned whether our system is working effectively and is compliant with current regulatory requirements to be competitive and meet the expectations of today. Therefore, we have implemented quality assurance procedures which meet both local regulatory requirements and international scientific standards.
Our SOPs ensure that the minimum requirements under national and international regulations and guidelines are met. Our SOPs also guarantee that each specific task and function within our operations is conducted in a uniform and standardized manner.
    Quality assurance department
The staff of our quality assurance department, who have an extend practical experience in the area of clinical trial’s monitoring, audits carried out by the sponsor and inspections of the regulatory authorities, carry out independent GCP audits, system audits and preparation of centers.
 
    Our services include audits:
      -   GCP audits: CRO, Investigational sites, documents of Trial Master File, audit of laboratories, depot audit, Pharmacovigilance audit
      -   Preparing sites to audit and inspection
      -   System Audit 
 
    The customer receives:
      -   Plan of the audit
      -   Audit report with detailed description of the findings and their gradation according to their importance.
      -   After the audit, a detailed discussion of the report, proposed corrective and preventive measures with the purpose of the desired goal achievement are pursued. Additionally, we train the team in order to avoid future violations.
 
We have developed a full quality system to cover all aspects of trials. With ESMAR you are sure to get the best quality!