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Back to the forum  Query: 2017-11-22 17:40 CET (UTC+1h)
 

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

posted by ElMaestro - Denmark, 2017-07-06 22:59  - Posting: # 17513
Views: 816

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.:-)

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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