Clinical Services Quality Assurance

Quality Assurance

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. This 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. In addition, our Quality Assurance team also conducts vendor audits and conducts reviews of protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), and regulatory submission documents. Our Quality Assurance team provides staff training opportunities based on industry trends, audit findings and regulatory updates.

Roy Wells
Senior Auditor, Quality Assurance
Roy has over 20 years of industry experience in quality assurance and regulatory affairs. His knowledge of global regulatory and quality assurance requirements, along with his ability to respond quickly to the needs of CTI employees, sponsors, and sites, have made Roy a strong resource in quality assurance.

Roy Wells

 

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

Request Information

Icon Clinical Small Retina

Find out how CTI's clinical trial services can help your next trial

Contact Us