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Re: freethemice post# 95877

Thursday, 09/27/2012 11:36:17 AM

Thursday, September 27, 2012 11:36:17 AM

Post# of 347009
I asked a related question on the BV board. This is the response from a former Genentech employee:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79985310
dependent on the contract, but most likely the CRO will have to pay some penalty but not be financially responsible for a full trial. You wouldn't want that same CRO doing the next trial anyway.

This is hard to blame on a CRO as the sponsor should have oversight. Every trial I have worked on as a separate unblinded person (in the company or consultant) who doublechecks the vendors's(CRO) treatment assignments.

Randomization and treatment assignment mishaps are the most important aspect to control and have good oversight on because they can completely ruin a trial. You can be hands off in other areas if you are low on resources, but not in this area.


http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79879413
You either have an unblinded statistician in house or another unblinded consultant to oversee or just double check. This is a given in every trial I have worked on and the lack of shows pphm's inexperience
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