Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-14 00:01 (1960 d 01:32 ago) – Posting: # 20031
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Dear Osama,

❝ I have already dealt with such study conducted for an anti-cancer drug in different CRO's in different cities.


Well, I've seen a few too, and all used a single, central bioanalytical lab...

It is true that it requires some logistics: local processing and storage of the samples, delivery of dry ice, pick-up of the samples by specialised transporters etc. All this does have a cost. On the other hand, you save on the development and validation of a bioanalytical method at each local laboratory. Plus the audit of each lab and QC of what they do. And an increased variability means a loss of power, thus additional patients needed.

CROs involved in this type of studies usually have a network of clinical sites with which they are used to working. They take care of all the logistics. If not: find another... It's worth it.

Regards
Ohlbe

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