Quality Assurance & Control
Quality Assurance (QA) and Quality Control (QC) help to prevent flaws or errors in both the product and the process and enhance quality consistent with the Sponsor’s goals.
LBR professionals have conducted various types of QA and QC audits including:
- Routine QA Site Audits
- For-Cause Site Audits
- Site Inspection Readiness Audits for FDA/EMA Inspections
- Vendor Qualification Audits (including IP manufacturing vendors, preclinical providers, clinical laboratories & IP storage/shipment vendors)
These QA and QC audits have been performed in many different geographies:
- North America (United States, Canada and Mexico)
- South America (Brazil & Colombia)
- Europe (Germany and UK)
- Eastern Europe (Poland, Czech Republic, Serbia, Romania, Georgia, Russia, Bulgaria, Ukraine, Hungary & Austria)
- Asia (China & South Korea)
- India
LBR Program Management and Project Management Services
Quality Assurance Services Include:
- Clinical Site Audits
- Database Audits
- Site Qualification/Audits
- For-Cause Audits
- Clinical Study Report Audits
- Regulatory Submission Audits (IND, INAD, NDA, NADA, etc.)
- Quality Systems Audits
- Site Inspection Readiness Audits
- Vendor Audits
- Preparation & Maintenance of Audit Plans
Quality Control Services Include:
- Clinical Monitoring Activities
- Verification of Regulatory Document Start-up Packets
- Data Listings
- Data Base
- Final Clinical Study Reports
