Mary Kay Sobcinski, Clinical Senior Principal Advisor
The time to answer “yes” to the question “are you ready for an FDA Bioresearch Monitoring Program (BIMO) inspection?” is not near or at the end of a trial……it’s at the beginning. And in the middle. And of course, at the end. Inspection readiness is an ongoing and vital component of every clinical study. Readiness requires corporate commitment and departmental prioritization to ensure staff are confident and well-trained, processes are adequate and adhered to, and documentation is in place to demonstrate compliance.
RCRI is frequently asked by sponsors to draft standard operating procedures (SOPs), perform gap analysis of existing SOPs, perform clinical compliance and trial master file audits, train staff on inspection behavior and conduct mock BIMO inspections. Through these activities, we’ve learned how to best counsel our clients to be ready for an inspection at all stages of a clinical development program.
Tips to be Ready for a BIMO Inspection
Perhaps the most important piece of advice we give our clients is to always be ready. It’s very common for sponsors to assume its SOPs are adequate and files are complete and well-organized, but it’s less common for sponsors to proactively assess these critical elements. To always be ready, we recommend the following actions:
- Conduct regularly scheduled review of your “real practices” against your SOPs and applicable regulations to ensure you are compliant and can prove compliance through documentation. If you are not compliant, either revise your SOPs to match your practices and regulations or update your practices to be compliant.
- Ensure clinical study file maintenance, whether paper or electronic, is a priority throughout the study, from start to finish. File maintenance, at best, is unglamorous and tedious, but its importance cannot be underestimated. At the end of a study, you have two things: a collection of study data and a collection of study paper. Both need to be complete, accurate and pristine to ensure you pass regulatory reviews and inspection and ultimately attain regulatory approval.
Getting Buy In
Corporate management does not typically understand the critical importance of ongoing inspection readiness. But they understand that failure to pass an inspection can result in a Form 483, a Warning Letter, or even rejection of the study on which many months and dollars were spent. Helping management understand the “penny saved is a dollar earned” philosophy toward inspection readiness will help ensure the clinical department has the resources dedicated to robust trial management and documentation to assure successful inspection readiness and ultimately, finding-free inspections.
Need to Know More?
RCRI consultants are available to help you think about your clinical quality strategy. To be put in touch with an RCRI expert, contact Samantha Spence at email@example.com or 952-224-2260.