Hi all,
My understanding of Japan's Clinical Trials Act and current practices there are limited, and I couldn't find an answer to this question in searching previous posts, so hoping someone can assist!
-- Is Japan currently permitting remote site monitoring or remote site initiations, or do these need to all be in-person?
We'll be working with a partner there, but we're trying to identify costs to budget for that would differ from what we do here in the U.S. (We typically do site initiations remotely for sites we have prior experience with and we use a mix of remote and on-site monitoring visits)
Also if anyone can identify other major costs we should plan for that would differ vs. in the US, I'd be most appreciative!
Thank you! Ken
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Kenneth Rockwell PharmD, MS
Director of Regulatory Affairs
Philadelphia PA
United States
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