Clinical Quality Assurance

Because quality is a vital aspect of the clinical trials we conduct, every project initiated at Theorem Clinical Research is assigned a clinical quality assurance (CQA) project leader. This experienced professional prepares a quality plan for each study and coordinates all CQA activities and conducts most audits.

Because our CQA team operates as an independent business unit, their services are offered as part of our integrated service or on a contract basis. This independence also allows them to conduct internal compliance audits throughout each study and across all functions. A comprehensive report is issued for all contracted CQA services, including practical recommendations for issue resolution and recommendations for preventive actions. Multilingual Theorem CQA professionals are stationed around the world to ensure rapid mobilization of our resources.

Clinical Quality Assurance Services

• Audits
• Process Assessments
• Trending Databases of Audit Findings
• Risk Assessment of Audit and Inspection Findings
• Development of Corrective and Preventive Actions (CAPA)
• Comprehensive Training