"Different languages,medical cultures, computer systems, computer software"
No.
Even Russian sites will enter data in English (just like Russian pilots speak to Aircraft Control in English - even in Russia).
The Clinical Record Forms and the software for registering them will have been uniform across all the sites, US and Russia alike.
"missing test results especially dealing with ill patients."
The first part is true. It's clear that validating the data hasbeen an issue with this study, given that three months after LPLV they still haven't locked the database.
But as for "especially dealing with ill patients", it may come as a shock to you, but every Phase II and Phase III study deals with sick patients. Quelle suprise, hein?!!
"It is challenging dealing with 200 different patients."
But presumably it would be 40% less challenging dealing with 120 patients in the brilacidin study?
Makes you wonder how Merck and others deal with the thousands of patients in their COVID-19 studies.
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