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PRACS Institute
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Frequently Asked Questions from the Public
Why
is PRACS Institute, Ltd. in the Red River Valley?
The reason is simple. Dr. Carlson was teaching at the College of Pharmacy
at North Dakota State University when he became involved in evaluating
generic drug products. The original game plan was to build a small study
unit to provide a site for university faculty to follow their clinical
research interests. Now, with over 20 years of growth, with over 12,000
annual study participants, with over $12,000,000 paid in annual volunteer
fees, with great staff and with great study participants … it now
all seems very logical and very appropriate to be located in the Red River
Valley ... just because! As a side note, there is no university research
or faculty at PRACS Institute, Ltd.
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Why
do companies place drug research at PRACS?
PRACS is contracted by North American pharmaceutical drug manufacturers
(and some international companies) to evaluate their product in an open,
unbiased manner and without conflict of interest. PRACS is an independently
owned research organization with no links to or stock investments in the
drug industry. The management at PRACS has worked very hard for over 20
years to assure our ethics will not be compromised and our integrity cannot
be questioned. Because PRACS has an excellent integrity reputation with
the U.S. FDA and the drug industry, that same integrity is passed on to
the products evaluated at PRACS and we expect the same ethical standards
from our clients.
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Why
does PRACS do drug research?
We evaluate drug products to determine if they meet the standards established
by the U.S. Food and Drug Administration (FDA). These strict standards
are required for both brand new drugs and generic drugs. If these standards
do not meet federal requirements, the FDA will not allow the drug company
to sell those prescription or non-prescription products to U.S. consumers.
Therefore, work completed at PRACS must be meticulous and intensely accurate.
Likewise, our integrity has a tremendous impact on assuring safe drugs
are dispensed in pharmacies all over the U.S. and North America (not just
North Dakota and Minnesota). Our staff knows they are having a tremendous
impact on U.S. healthcare.
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Why
do drug companies continue to work with PRACS?
This answer is simple … it is because of our staff and our study
participants. With regard to staff, we have happy, responsible, reliable,
honest and friendly staff. In contrast to some of our competitors, our
staff has worked at PRACS for years and typically only leave for educational
opportunities outside our area or to accompany their mobile significant
other. This means our clients will have the opportunity to work with the
same staff with each project. Clients like the stability and employment
duration of our staff.
And of course,
of equal importance are our study participants. Our participants are friendly,
compliant and clean. From the drug companies point of view, this means
if we enroll and dose 36 participants, we will probably complete 35-36
subjects. Our volunteers also have a very, very low incidence of positive
drug abuse screens as well as positive hepatitis and AID’s lab results.
This makes handling blood specimens safer for our lab staff and the company’s
staff. And last of all, our participants are just plain clean, friendly
and open to queries from our clients.
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Why
should you participate in a PRACS study?
There are two major reasons. The first may be your personal needs …
a few extra dollars to pay bills, college tuition, or maybe fun dollars.
And secondly, your participation in a study may ultimately result in either
a new drug regimen for patient care or cheaper generic drugs. Either way,
your time will positively impact the healthcare for several million people
in North America and potentially the world. You may have more impact on
healthcare by participating in a study than you ever imagined.
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What
happens to the drugs studied at PRACS?
The drugs studied at PRACS go to the FDA for review and, if accepted,
they are sold to the U.S. consumer as either prescription or non-prescription
drugs. Assuming you have friends or relatives who require medications
for immediate problems or for chronic treatment, you can also assume a
significant portion of those friends or relatives are taking medication
previously evaluated by PRACS. Now it may be a little clearer why the
PRACS staff are so meticulous and pay so much attention to detail.
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Copyright © 2003, PRACS Institute, Ltd.
