Retention of clinical biosamples / blank matrices [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2019-04-23 18:15 (751 d 18:10 ago) – Posting: # 20212
Views: 2,107

Hi jag,

» "we can always ask the CRO to extended the stability" :confused:

"...if we stored the samples along with appropriate QC's."

The thing is regulators throw a curve ball every now and then. Sometimes there is even a degree of rationale behind it. If the study is inspected or someone asks for re-analysis or any other activity of this type then you simply have much better chances of answering if you have the samples and the QCs still frozen.
CRO compliance suddenly questioned by an evil inspector? Send the B-set to another CRO, show BE with those samples, and Bob's your uncle!

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,460 posts in 4,486 threads, 1,513 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time: Friday 12:26 CEST (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

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