Clinical Quality Assurance

APCRA’s clinical quality assurance (CQA) auditors are knowledgeable about local, national and international regulations, standards and guidelines and have extensive experience and training in GCPs, GLPs, 21 CFR Part 11, computer system validation and auditing techniques. In addition, they have also conducted quality assurance audits for clinical trials in Asia, US and Europe.


Clinical Quality Assurance Audits

    Among our range of CQA services, we conduct the following:

     

  • Clinical investigator site audits. We provide routine, directed, specialized and pre-inspection audits to help sites prepare for regulatory agency reviews
  • Clinical database audits and study report reviews
  • Clinical study document reviews
  • System audits in which we assess client standard operating procedures (SOPs), processes and staff training programs and recommend improvements where needed
  • Vendor audits in which auditors evaluate a client’s vendors, to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations

  • GCP quality system development

  • GCP compliance and due diligence auditing, including overall and study-specific compliance.
  • Development of Corrective and Preventive Actions (CAPA)
  • Creation and review of SOPs, standard forms and templates, and study-specific procedural documents