Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-20 07:10 CEST (UTC+2h)

Centralized monitoring for BE? [GxP / QC / QA]

posted by ElMaestro - Denmark, 2017-07-06 22:59  - Posting: # 17513
Views: 1,661

Hi all,

with the new R2 revision of ICH E6 the issue of centralized monitoring is becoming a hot topic.
It is my understanding that CM is a process that is well accomplished in trials involving electronic data capture in devices that are regularly "phoning home" to deliver a load of data and progress indicators, or in multicenter trials where individual centers are communicating froma distance about their enrollment status.
EDC wizardry is still rare in BE. I have come across CM a few times the past year or two where honestly CM seemed to be mere excuses for not being on site, possibly due to a desire to avoid the logistical expenses. I have yet to see CM in an obviously meaningful manner for traditional BE. But perhaps it is just me overlooking some important points (that has happened so often before).

Could anyone here comment? Are you experts out there introducing CM in ordinary BE trials involving specialised CROs? How? How are risks identified and ranked in those case where CM is being scheduled?

Have a good day and thanks so much in advance for any input.:-)

if (3) 4

Best regards,

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,395 posts in 3,909 threads, 1,174 registered users;
online 37 (0 registered, 37 guests [including 18 identified bots]).

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

BEBAC Ing. Helmut Schütz