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Quality Assurance & Audits

Through well-established Quality Management Systems and methodologies in order to achieve risk-based quality management, reduce operational costs, maintain compliance and improve the quality of clinical trials.

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    • Quality Assurance 
      &Audits

      Through well-established Quality Management Systems and methodologies in order to achieve risk-based quality management, reduce operational costs, maintain compliance and improve the quality of clinical trials.

    Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. As more and more Multi-Regional Clinical Trials (MRCT) are conducted in China, it has never been more important for local CROs to conform to ICH standards. Luckily for CSC, we have incorporated it in every aspect of our work since establishment.

    Our Quality Assurance & Audit team is composed of audit consultants and full-time QA personnel, has an average of more than 15 years of experience in global and local clinical trial projects, more than 10 years of experience in clinical trial audits and Quality Management System verification. Many of our QA team are experts nominated by FDA and EMA. Some of them have also served as experts or trainers of local and foreign regulatory authorities, as well as professional training in the clinical trial training sites.

    Our auditors are familiar with global clinical trial laws, regulations guidelines and understand relevant disease treatment guidelines, and have rich practical experience in clinical trial design and planning, implementation and supervision, data collection and analysis, quality control and quality assurance, auditing and meeting pharmacovigilance inspections.

    • We can provide you with the following services:

      Third-party Audits

      QMS Audits

      Training Service

      Document quality and integrity verification and Trial Master File (TMF) qualification

      Pre-Inspection Preparation and Facilitation of Health Authority Inspections

    Third Party Audit:

    Clinical trial research centers (including drugs, medical devices, diagnostic reagents)

    Database and Statistical Analysis Audits

    Contract Research Organization

    Central Laboratory

    Investigational Medicinal Product Management

    Logistics

    IWRS/IVRS

    Audit Methods:

    Remote Audit

    On-Site Audit

    Flexibly develop/adjust the audit program according to your clinical plan and study progress, and provide you with more suitable audit services based on risk and problem management.