Research Center Profile:
PRACS Institute, Ltd.
PRACS opened its research services in 1983 and offers clinical,
bioanalytical and statistical services to the pharmaceutical
industry. Clinical research services conduct studies for
bioavailability, bioequivalence, drug interactions, dose ranging,
product concept, safety and efficacy. Bioanalytical services
include method development, method validation, cross validation and
routine bioanalytical drug sample analysis.
PRACS has over 20 years research experience in Phase I, II, III
and IV, OTC and cosmetic product studies with concurrent experience
in bioanalytical sample analysis and statistical data evaluation
and reports. PRACS has over 50 current pharmaceutical sponsors
ranging from international innovator and generic companies to
start-up manufacturers and formulators in North America and
Europe.
PRACS has two clinical research facilities represented by 14
outpatient exam rooms, 10 screening rooms, and 13 clinical study
units offering approximately 420 beds. Flexible inpatient units
allow expansion or contraction of study units for dosing 15 to 96
subjects concurrently. Bioanalytical services offers HPLC-UV, LC-MS
and LC-MS-MS with 96-well technology and Tomtec sample handling.
Our facilities range from our 7,000 sq.ft. bioanalytical site to
our 28,000 sq.ft. satellite clinic to our 123,000 sq.ft.
headquarters.
James D. Carlson, Pharm.D., President
Over 25 years clinical research experience
Alan Copa, Pharm.D., Director of Clinical Research
Over 14 years clinical research experience
Rick Wanderi, BA in Chemistry & Biology, Associate Director
of Bioanalytical Research
Over 25 years of bioanalytical research experience
James Havel, Sr. Bioanalytical Scientist
Over 14 years of bioanalytical experience
James Kapron, Ph.D., Sr. Bioanalytical Scientist
Over 18 years of bioanalytical experience
Peter Boldingh, Pharm.D., Associate Director of Clinical
Research
Over 6 years of clinical research experience
Ross Nygaard, Pharm.D., Associate Director of Clinical
Research
Over 4 years of clinical research experience
Scott Harrison, M.D., Medical Investigator
Over 23 years of medical experience
Craig Sprenger, M.D., Medical Investigator
Over 8 years of medical experience
Thomas Cariveau, M.D., Medical Investigator
Over 17 years of medical experience
Thomas Ary, Ph.D., Director Quality Assurance
Over 23 years of research experience
PRACS has over 56,000 persons in our database with over 34,000
active potential study participants. Our active female database
includes over 6,800 women of child bearing potential, over 1,150
natural or surgical post-menopausal women, over 1,100 surgically
sterile women and over 2,200 women on various oral contraceptives.
Our female and male database ranges from 18 to 96 and 18 to 92
years of age, respectively.
Fargo area population approximately 250,000
East Grand Forks area population approximately 100,000
PRACS in-house services include protocol, consent, and case
report form development, certified clinical laboratory, quality
assurance staff, bioanalytical sample analysis for drug bio-sample
content, bioanalytical method development, bioanalytical method
validation and/or cross validation, electronic data transfer,
interim and final statistical analysis of in-house or external
data, and extensive experience with paper and electronic ANDA and
NDA submissions. PRACS has completed over 1,600 in-house projects
since 1983.
John Pottier
Director of Business Development
PRACS Institute, Ltd.
4801 Amber Valley Parkway
Fargo, ND 58105-9358
USA
Phone: 701-461-8202
Fax: 701-239-4955
EMail: jpottier@worldnet.att.net
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the E-mail form below. A representative from
the research center will then follow up with you.
