Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-13 18:10 (683 d 06:06 ago) – Posting: # 20029
Views: 3,208

Dear Osama,

» Please think about very big clinical trials which required a multi-centers ( e.g for Anti-cancer drugs), you deal here with different CRO's which could have different technologies.

BE trials in patients are indeed usually multi-centre trials. But multiple clinical sites does not mean there has to be multiple bioanalytical labs (unless the analyte is so unstable the samples cannot even afford to be shipped to a central lab ? I don't have any practical example in mind).

The one difficulty could be if due to the study duration the lab closes down half-way through the study and a new lab has to be used.


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