Inspection Readiness Assessment, Training, and Mock Inspections
WCG Avoca’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 120+ AQC Member companies.
Mock audits: assessment of sites, CROs, and vendors. Mock inspections: assessment of sponsors. Integration of findings as needed.
Population of Inspection/ Audit Playbook with findings, management of risks/issues, and activation of teams.
Training and coaching during mock inspections/ audits inclusive of a recap of the observed positives and negatives.
SME support to address findings and ensure ongoing GCP compliance.
Be Inspection Ready
With Avoca’s Consulting Services for Inspection Readiness, you can:
- Discover trial-related issues with sufficient time to effectively manage the inspection risk.
- Provide your staff with the experience and tools they need for inspection preparedness and situational competency to handle inspectors and auditors.
- Gain insight into the inspection focus of health authorities.
- Organize and collate trial-related documentation ensuring documentation is as organized and whole as possible in advance of a true inspection/audit.
- Avoid delayed product launches and internal remediation costs resulting from inspection findings.
Leverage Our Expertise. Trust Our Proven Process. Be Inspection Ready.
Contact us to discuss your Inspection Preparedness needs: