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Quality Management System Design, Gap Analysis, Implementation, and Improvement

Gain Peace of Mind. Remove the Guesswork. Fill the Resource Gap.

WCG Avoca’s Consulting Services for the design, development, and implementation of a Quality Management System (QMS) aims to help sponsors and CROs develop a culture of risk prevention rather than one of managing issues.

A proactive, risk-based approach ensures patient safety, improves data quality, provides data integrity, and increases inspection preparedness.

Why is a Quality Management System Important?


To be compliant with ICH E6 (R2), risk-based quality management for clinical trials is required. A QMS is a framework for all activities, including quality control, quality assurance, quality improvement, and the reporting of these activities within an organization.

Learn how quality management system components affect inspection readiness – watch our webinar.



The Avoca Advantage

– Consulting –


Over the past 20 years, Avoca has built a proven process to help sponsors and CROs drive efficiency in clinical trial execution. We developed a 12-component construct to facilitate comprehensive, robust gap assessments of existing QMS.



Using our construct, we help to ensure your QMS is compliant with current regulatory requirements (e.g., ICH E6 (R2)) and leading industry practices and standards.


We leverage knowledge and information from daily inspection experiences to develop strategies, plans, and tools to navigate the diverse, changing inspection environment. All Avoca processes and materials are proactively aligned with new regulatory guidelines. Subject matter experts (SMEs) are paired to each project based on their expertise and ability to assess the areas of need, resulting in a full team of dedicated experts.


– Tools –


We alleviate time, staff, and other resource constraints that prevent compliance and preparedness assurance — allowing your team to focus on their core responsibilities. To simplify and streamline the successful implementation of your company’s QMS, we leverage the more than 400 quality management and inspection readiness leading practices, tools, and standards developed and refined by the Avoca Quality Consortium® (AQC).



Leverage Our QMS Consulting Service




Contact us to ensure your QMS is appropriate and compliant: