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At TRI, we approach quality assurance from the inside out! Our independent Quality Assurance department regularly assesses the quality of all of the services we provide. Internal process audits are conducted to validate our compliance with SOPs, GCPs, and other applicable standards of Good Clinical Practice. We routinely perform both individual project and overall quality system audits. Because quality assurance is a critical aspect of any clinical study, we also provide a range of quality assurance services to our clients. These services include:
- Case Report Form Review
- QA/GCP/ICH/HIPAA Training and Implementation Oversight
- Clinical Study Document Audits
- Good Clinical Practice Site Audits
- Regulatory Risk Assessments
- Pre-submission Regulatory Documents Audit
- Pre-FDA Inspection Site Preparation
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