Contract Research Organizations
Mary Rose Keller, Sangart: Commodification of clinical research
is not attractive to R&D; colleagues. It suggests that success lies in
faster and cheaper, not in better outcomes for patients or investors. Bid defense should be more about how the CRO approach
will deliver quality data to define a clear outcome than reviewing
hundreds of lines of cost detail. Metrics are important, but how
they are achieved is more important. Keep the messages simple. If
you can draw your study management organization on the back of
a napkin in the lobby of the hotel, you can probably run my study.
DESCRIBE A SITUATION WHEN YOU WISH YOU HAD
OUTSOURCED SOONER AND WHY?
Green: I can share a time when I wish we had switched vendors
sooner. We were working with a small non-GMP protein manufacturer to take a university manufacturing process from the first
small-scale validation of the process through to making the first
material. As the lots grew slightly larger, the material was tending
to be more insoluble, and therefore, would require the expertise
of a team with experience in removing proteins from inclusion bodies. The vendor didn���t have that expertise. A mistake can occur when work shifts and the focus moves
outside the vendor���s level of expertise.
of the work could have been performed at the same time,
thus resulting in the earlier (and potentially less
stressful) completion of the entire project.
Keller: In a previous company, we
needed to conduct a very simple
classical Phase 3 study in a
common condition. At
the same time, we
were going to
start a new
program
with the
same
Mitch Katz, Purdue Pharma L.P.:
While implementing certain
development plans, I have
needed to work sequentially. If I had utilized
outsourcing, much
In the big world of clinical trials,
it���s the small stuff that counts.
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