Inspection Readiness for Clinical Research Inspections

At MVG Consulting Services, we feel that inspection readiness should be built into all processes during the clinical development of a product. It is our experience that, with good planning upfront at the beginning of the program, many of the issues found during an inspection can be either prevented or their impact lessened. When we start a project with one of our clients, we help them incorporate strategies for a successful inspection that can be followed throughout the development lifecycle of a product.

We incorporate these strategies in the following areas: 

• Regulatory documentation review
• Investigator selection and management
• Vendor selection, management and oversight
• Trial Master File oversight
• Monitoring procedures and activities
• Clinical site management
• Evaluation and reporting of adverse events and serious adverse events
• Standard Operating Procedures
• Training
• Investigational Medicincal Product (IMP) accountability and documentation

Our experience has been that many clients think about inspection readiness when an inspection is imminent due to the filing of a marketing application. Keeping an Inspection Readiness mindset throughout your clinical development program will help in the long-run to increase the odds of a successful inspection.