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Clinical Quality Assurance

At CBCC-Vibgyor, we have a dedicated team for Quality Assurance that strives to provide thorough coverage for our internal as well as Sponsor’s quality requirements. Our QA team ensures adherence to applicable regulations and guidelines through carefully planned audits and detailed reports.

Our Clinical QA Service includes following:

  • Due diligence audits (CROs, ECs,clinical study sites, clinical/diagnostic/core laboratories, clinical data management, clinical supplies distributors)
  • Audit of clinical trials including the audit of prospective,site documents study documents, investigational sites, databases, and final reports
  • Clinical study report and regulatory submission document audits
  • Clinical data management process audits
  • Systems audits (pharmacovigilance and drug safety reporting, computer system validation documentation compliance,clinical research operations)
  • Clinical research SOP gap analyses and needs assessment
  • Training for GCP requirements
  • Assistance in the implementation of regulatory and GCP requirements
  • CAPA (Corrective and Preventive Action) plans and implementation
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