Quality Assurance/Auditing

Averion provides Quality Assurance services to support clients throughout the clinical research and development process. At Averion, dedication to quality is our commitment. Our global Quality Assurance (QA) team has the clinical and technical expertise to ensure that the appropriate quality systems are in place for our client's clinical study.

In addition to providing routine internal quality assurance support, Averion's QA team provides auditing services to its clients.

Auditing Services include:

• Pre-Regulatory Inspection GCP Audits/Inspection Readiness
• Clinical Investigator Site Audits
• GMP/Investigational Product Storage, Distribution & Manufacturing
• GLP/Central or Local Laboratories
• Clinical and Specialty Vendor & Service Provider Audits/Assessments
• IRB Audits
• Trial Master File Audits
• Validation/21 CFR Part 11 Compliance Audits
• Standard Operating Procedure (SOP) Evaluations
• Systems/Process Audits