Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-13 23:01 (593 d 19:29 ago) – Posting: # 20031
Views: 3,075

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

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,474 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Tuesday 18:31 CET (Europe/Vienna)

No computer has ever been designed
that is ever aware of what it’s doing;
but most of the time, we aren’t either.    Marvin Minsky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5