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Posted On: 10/06/2021 2:52:41 PM
Post# of 148902
Re: FredWasHere #106868
Fred -
A couple of decades ago, I had to step in as Chief Info Officer at a good-sized biotech (I was Treasurer when issues emerged), so I have been responsible for an EDC system, as we were our own CRO on most trials.
You aren't just talking software. You are talking all the workflows relating to getting it into the system, validating it and being able to prove computer results back to physical pieces of paper.
The FDA pulled flash audits - they would show up with a team and you would have twenty minutes to have your team sitting in the (huge) dedicated EDC automated file room to answer every question they posed.
It's so hard to imagine a group like Amarex is described not having being sanctioned by the FDA already.
A couple of decades ago, I had to step in as Chief Info Officer at a good-sized biotech (I was Treasurer when issues emerged), so I have been responsible for an EDC system, as we were our own CRO on most trials.
You aren't just talking software. You are talking all the workflows relating to getting it into the system, validating it and being able to prove computer results back to physical pieces of paper.
The FDA pulled flash audits - they would show up with a team and you would have twenty minutes to have your team sitting in the (huge) dedicated EDC automated file room to answer every question they posed.
It's so hard to imagine a group like Amarex is described not having being sanctioned by the FDA already.
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