Services

QAS offers the following types of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) services:

Quality Management:

• Clinical QA Management
• GCP Training
• SOP Evaluation & Development
• Inspection Readiness Assessments
• GCP and GLP Auditing
• Expert Testimony

Auditing Services:

• Good Clinical Practices
• Pre-Approval Inspection Readiness
• Trial Master File
• Safety Surveillance
• Adverse Event Reporting & Safety Surveillance Audits & Assessments
• Clinical & Specialty Lab Audits & Assessments
• Clinical Research Process Audits and Assessments
• Clinical Study Report Audits
• Clinical Trial Center Audits (“Site” Audits)
• Computer System Validation Audits
• Contract Research Organization (CRO) Audits & Assessments
• Core Lab Audits & Assessments
• Data Management, Statistics & Statistical Programming Audits
• Database Audits
• GLP Laboratory Audits
• Regulatory Submission Audits (e.g., NDA, BLA and PMA)
• Data Trend Analysis
• 21 CFR Part 11 (Electronic Records; Electronic Signatures) Audits & Assessments
• Application Integrity Policy Auditing and Consulting
• Institutional Review Boards (IRBs) Audits

Training Courses:

• Auditing Techniques
• Retrospective Data Collection
• Good Clinical Practices
• Clinical Quality Assurance Auditing
• Computer Systems Validation
• Pre-Approval Inspection Readiness

SOP Development:

• Clinical Development
• Clinical Quality Assurance
• Clinical Data Management
• Computer Systems Validation