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.
View Avoca’s Inspection Readiness Webinar Recordings and Slides:
|July 25, 2018: Risk-Based Inspection Preparation|
|September 25, 2017: Inspection Readiness Challenge|
|July 6, 2017: QMS and Inspection Readiness|
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: