Quality Assurance

    CTI’s Quality Assurance team provides valuable input into improving internal processes and ensuring compliance with regulatory requirements, protocol adherence, and global standard operating procedures (GSOPs), promoting research subject safety and data integrity.

    CTI has an independent Quality Assurance team reporting directly to the CEO. Our Quality Assurance team has decades of industry experience and performs audits of internal systems and processes, departments, and study-related services and procedures.

    Providing insight into clinical practice at all phases of study conduct:

    Our Quality Assurance team internally supports:
    • Internal system audits
    • Trial Master File (TMF) audits
    • Vendor qualification audits
    • Investigative site audits
    • Regulatory document audits (protocols, CSRs, IBs, regulatory submission documents)
    • Database audits
    • Computer system validation audits
    • Staff training
    • GSOP reviews and system oversight
    • Hosting sponsor audits
    • Management of a Corrective and Preventive Action (CAPA) program
    CTI can also provide the following auditing services for sponsors:
    • Trial Master File (TMF) audits
    • Vendor qualification audits
    • Investigative site audits
    • Regulatory document audits (protocols, CSRs, IBs, regulatory submission documents)
    • Database audits
    • Computer system validation audits
    • Site preparation for regulatory inspections