Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-13 23:01 (674 d 19:40 ago) – Posting: # 20031
Views: 3,178

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
21,303 posts in 4,441 threads, 1,487 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Saturday 18:42 CET (Europe/Vienna)

If you can’t solve a problem, then there is an easier problem
you can solve: find it.    George Pólya

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