Inspection Readiness Assessment, Training, and Mock Inspections
The Avoca Group’s Consulting Services for Inspection Readiness provide full management through point-of-need support for inspections.
We aim to help sponsors and CROs develop a culture and mindset that are committed to quality through proactive risk management, ensuring an inspection readiness state throughout the entire clinical program.
Leverage Our Expertise
This service is based on our 20+ years of experience with risk mitigation, quality improvement, and commitment to efficiency in clinical trial execution. Our inspection preparedness model offers a comprehensive system that provides confidence for our clients.
We develop strategies, plans, and tools to navigate the diverse, changing inspection environment.
- Leveraging our knowledge and information from daily inspection experiences
- Utilizing the Avoca Quality Consortium® (AQC) Knowledge Center repository of global regulatory agency approaches to inspections and other industry experiences
- Proactively aligning all Avoca processes and materials with new regulatory guidelines (e.g., ICH E6 (R2))
Clients benefit from a full team of dedicated experts—subject matter experts (SMEs) are paired to each project based on their expertise and ability to assess the areas of need.
- Support for inspection readiness
- Quality and compliance consulting/remediation support
- Dedicated, embedded inspection lead to manage and report on inspection preparation activities
Trust Our Proven Process
Our agile inspection preparation process is based on industry-leading practices and tools for inspection readiness and proactive, ongoing inspection preparedness developed in collaboration with the 90+ AQC Member companies.
Be Inspection Ready
With The Avoca Group’s Consulting Services for Inspection Readiness, you can: