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.

For more information, please contact:

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
E-mail:

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Last updated on August 21, 2008