(Total Views: 636)
Posted On: 05/23/2023 8:33:16 AM
Post# of 154171
Re: Buddyboy20 #134644
Quote:
4:05: Now, with that being said, we are confident that the primary findings of the study are sound. Since these assessments did not find any serious integrity issues at the level of the clinical trial sites, and due to the CRO's inadequate process and performance around the Monitoring and Oversight of the Data*, there are* significant challenges to meeting the high bar of passing an FDA GCP Audit*.*
So when there are no serious íntegrity issues with the clinical trial sites why is it not possible to start over with the original data from the trial sites?
Can I assume the inadequate "Monitoring and Oversight of the Data" by Amarex is the key phrase for the death sentence of this trial?
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