•   White Paper: Risk-Based Inspection Readiness
•    Inspection Readiness Q&As
•   Article: (R2) Guidelines & Industry Inefficiency
•   Blog: Prepared for Risk-Based Inspections?
•   Blog: IR: How do we get there?
•   Blog: Avoca Shares Inspection Experiences
•   Blog: Insp Preparation Risk-Based Approach
•   Download Printable PDF
•   Request more information

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.

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

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 200+ 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.

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.