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RegisterAnother two... [GxP / QC / QA]
Dear all,
It looks like the FDA has just keelhauled 2 CROs again: Panexcell and Synchron Research. The FDA will reject all data from both CROs due to data manipulation. All Panexcell data had already been rejected in the EU.
The FDA letters are very explicit regarding what they have found, and their conclusion is crystal clear:
Put simply, because you have been responsible for the creation of false data in the studies discussed here, we have no reason to believe that any data that you have produced are reliable. Thus, FDA has determined that all study data from all studies conducted at your firm must be rejected.
It looks like the FDA has just keelhauled 2 CROs again: Panexcell and Synchron Research. The FDA will reject all data from both CROs due to data manipulation. All Panexcell data had already been rejected in the EU.
The FDA letters are very explicit regarding what they have found, and their conclusion is crystal clear:
Put simply, because you have been responsible for the creation of false data in the studies discussed here, we have no reason to believe that any data that you have produced are reliable. Thus, FDA has determined that all study data from all studies conducted at your firm must be rejected.
—
Regards
Ohlbe
Regards
Ohlbe
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Ing. Helmut Schütz