Inspection Readiness Assessment, Training, and Mock Inspections

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) and (R3))

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 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.

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.