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Posted On: 08/23/2021 12:05:14 PM
Post# of 72443
Imputing Russian ability to Manipulate Data at Russian sites... is a "WELL DONE NOTHING BURGER". Otherwise, FDA would not have approved IPIX Trial protocol and site selection!
Quote:
' You gonna trust letting Russia run most of our trial sites?
Russian Trials... are done with random FDA "site review".
The FDA confirms MO as compliant with FDA standards...and approval by FDA makes the quoted comment above and its inference... baseless.
The RAW results of the trials in Russia and the U.S. (blood samples, etc)...data is assembled and shipped by the US Supervised CRO at the site, then forwarded, assembled, and scrubbed at the US or EU Lab chosen by U.S Supervising CRO outside Russia...that information is received off-site and is entered by FDA approved Data Computer company, which generates computer data for analysis...none of the scrubbing, assembly, and data entry is a function of a Russian (or US) Clinical Trial site...
The ultimate CRO Supervisor (engaged by IPIX) in the U.S. The sub-CRO engaged in Russia by U.S. CRO causes the delivery of raw information to or under direction and review of Supervisory CRO...to western labs...not Russian labs.
Nothing to fret about here...process and ALL CROs were disclosed by FDA when IPIX received approval for trials...
KNOW WHAT YOU OWN...and Just hold on to what you have...everything will come out in the wash...when Trial Results reported, IMO, in days...
Quote:
' You gonna trust letting Russia run most of our trial sites?
Russian Trials... are done with random FDA "site review".
The FDA confirms MO as compliant with FDA standards...and approval by FDA makes the quoted comment above and its inference... baseless.
The RAW results of the trials in Russia and the U.S. (blood samples, etc)...data is assembled and shipped by the US Supervised CRO at the site, then forwarded, assembled, and scrubbed at the US or EU Lab chosen by U.S Supervising CRO outside Russia...that information is received off-site and is entered by FDA approved Data Computer company, which generates computer data for analysis...none of the scrubbing, assembly, and data entry is a function of a Russian (or US) Clinical Trial site...
The ultimate CRO Supervisor (engaged by IPIX) in the U.S. The sub-CRO engaged in Russia by U.S. CRO causes the delivery of raw information to or under direction and review of Supervisory CRO...to western labs...not Russian labs.
Nothing to fret about here...process and ALL CROs were disclosed by FDA when IPIX received approval for trials...
KNOW WHAT YOU OWN...and Just hold on to what you have...everything will come out in the wash...when Trial Results reported, IMO, in days...
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