Imagine you are Senior VP at a company called PharmaABCD Inc. PharmaABCD Inc. just completed Phase III of a drug trial, in which the test article was indicated for the treatment of hypertension. PharmaABCD Inc. used a Contract Research Organization (CRO) located outside the US to conduct and oversee the progress of the trial. All the participating Clinical Investigator sites were located outside of the US. The NDA was recently submitted to FDA, and the CEO has asked you to prepare a strategy in anticipation of an FDA BIMO site inspection. Your task is to develop a plan to get the CRO and clinical sites ready for an FDA inspection.

Some potential issues to consider are:

• There are no paper records at the sites since everything is computerized
• 25% of the subjects enrolled were illiterate, and Informed Consent was electronically documented by the Clinical Investigator
• Clinical Investigators were required to follow all the local rules governing ethical oversight of clinical research

As part of your plan as VP, you may decide to develop a formal SOP to be followed for each entity that could be inspected (i.e.-CRO; Clinical Investigator; Sponsor). Alternatively, you could also develop a plan for conducting mock audits at the sites, and possibly establish criteria for how you may address potential non-compliance identified.

Take into consideration the unique issues associated with conducting international clinical investigations, using computerized systems, outsourcing regulated activities to a CRO, and ethical oversight.

You may also want to reference FDA's BIMO Compliance Program Guidance Manuals (CPGM), which provide instructions to FDA investigators on how to evaluate a site conformance with FDA regulations, during a BIMO inspection: