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The following message was posted to: PharmPK
From a theoretical viewpoint-quite off the normal track of discussion,
1) I was wondering about what features of misrepresentation of a CRO's
capabilities on the internet constitute punishable fraud?
Misstatements of experience?
Misstatements of capabilities and assets?
Misstatement of location? Or are these essentially non issues?
2) What features of a CRO-apart from the regular scientific and
technical
assets need to be investigated before placement of work, for example:
A) Years in the business?
B) Past relationships with sponsors and vendors?
C) An understanding of the financial stability of the CRO?
D) Conduct of the CRO towards current and former employees?
E) Record of the CRO's observation of Regulatory Issues?
F) Record of the CRO's observation of the home state's Labor Laws?
G) Record of the CRO's activities (and ROI) towards those who have
invested capital, labor or equipment as shareholders or partners?
If there are additional features please add as needed.
I would appreciate your candid responses to these questions. Thanks
you in
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The following message was posted to: PharmPK
In terms of working with a contract lab, the most basic of principles
applies: caveat emptor. Toward this end, it is always a good idea to
visit
the lab prior to working with them to ensure that there is a match
between
how they have represented themselves and what is observed during a
qualification visit. Misstatements of experience are commonplace on
websites, and finding that a lab has misrepresented itself regarding
experience, capabilities and location (I would hope that the address
should
match the place where the visit occurs) should be grounds for
disqualification. If the lab is used despite any irregularities that
were
uncovered, well, caveat emptor. And if the work is regulated, Godspeed.
As for the 2nd part of your inquiry,
A) Yes;
B) This tends to be confidential;
C) Absolutely, especially today;
D) If you know any of them, but former employees might bear some
resentment
toward the company, better to rely upon comments from current
employees if
you know them;
E) Yes, with careful attention paid not to the fact that they received
a 483
but their response to it;
F) I don't know how this can be investigated, but if it is public
knowledge,
then yes. Perhaps a standard question on a qualifying document might be
whether the company has an pending litigation and what the nature of
such
litigation might be;
G) I would think that this would be hard to discern for a private
company;
Others would include discussions with Scientists and Project Managers
during
the visit to assess technical acumen as well as regulatory compliance if
applicable and adherence to SOPs.
Mickey O'Brien
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