want our clients to give up points
of probability on the trial’s success
to save time,” Resnik says.
The focus of reducing
variables, while still delivering
a product that will achieve a
positive FDA or regulatory board
perception is not a task for the
naively experienced; it takes a
veteran like Bio Rasi to truly
navigate through all factors.
“
We have two clients. One of the
clients is the sponsor of course.
But the second one is the FDA
or the regulatory authority at
hand. Our aim is to adhere to all
the peculiarities which come our
way including the perceptions of
the FDA,” says Resnik.
September 2012
thcare Initiatives
page 337
