Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-14 00:01 (2315 d 08:12 ago) – Posting: # 20031
Views: 6,060

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:

UA Flag
Activity
 Admin contact
23,436 posts in 4,932 threads, 1,677 registered users;
38 visitors (0 registered, 38 guests [including 10 identified bots]).
Forum time: 09:14 CEST (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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