Question: What do you think are compliance differences and considerations ( if any ) for the conduct of a clinical trial in an emerging country, where

What do you think are compliance differences and considerations (if any) for the conduct of a clinical trial in an emerging country, where basic medical standards and practice may be much less sophisticated than here in the US. How do you feel about a US company conducting its clinical studies in another country instead of (or in addition to) conducting clinical trials in the US? Does this raise any ethical or quality considerations? Will it impact what you monitor and what are your expectations? Will it impact FDA's acceptance of the data based on where the study was conducted?

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