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Compliance In Focus
Posted by John Lehmann on Mon, May 2, 2016

Learning to Trust the Process

Trust_2rev.jpgMerriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something. Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.

We wanted to share with you a case study that we call “Trust the Process,” written to help highlight a situation we often face. IMARC Research is often hired to conduct FDA Bioresearch Monitoring (BIMO) preparation audits at sites. This type of visit is used to identify and mitigate any weaknesses that may surface during an FDA inspection, educate the sites on what to expect during an FDA inspection, and provide tips on how to interact with the FDA investigator. Conducted by a senior level monitor or management personnel who has experience with preparing sites for FDA audits, these types of preparation visits have been done at both US and OUS investigational sites.

Please take time to download our case studyand review how IMARC helps sites to gain confidence and achieve success when facing an FDA audit. Let us know your thoughts on our process for audit prep. How would you help a site prepare for an FDA inspection? What would you do first? Leave your thoughts below!

In Vitro Diagnostics

photo credit: day 5 via photopin (license)

Topics: Case Study, FDA Audit, Trust the Process


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