“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution.” – William A. Foster Quality is one of Vantage BioTrials’ most important elements when conducting monitoring or quality assurance audits of investigational sites or Contract Research Organizations. Here’s a list of what we can do for you to help maintain Quality for your studies: Generate audit reports and review for accuracy, clarity and completeness. Ensure that impact/validity assessments are clearly written and, where appropriate, support the facts. Manage event investigation process and ensure regulatory compliance for all studies reviewed. Conduct general inspections/monitoring of Phase I-IV studies in compliance to Protocols, SOPs, GLPs, GCPs and generally accepted scientific principles. Audit raw data records for completeness and within compliance to Protocols, SOPs, GLPs, GCPs, 21 CFR Part 11 and generally accepted scientific principles. Audit of reports to ensure that the results incorporated accurately reflect the raw data. Gap analysis of processes and organization Vendor audits Quality System Optimization including development of quality manuals and policies, SOPs, work instructions, QA processes, training, and regulatory inspection readiness programs.