4801 Amber Valley Parkway
Fargo, ND 58104, USA
Contact Person: Katherine Cloninger
Analytical Assay Development and/or Laboratory Service, Clinical Pharmacology, Data Management, Inpatient/Outpatient Facilities, Investigational Site/Network, Medical Writing, Patient Recruitment, Pharmacokinetic/Pharmacodynamic Modeling, Therapeutic Specific Research, Trial Management
PRACS – Innovative, Flexible, Dedicated Industry Leaders
PRACS Institute is an early phase clinical research organization providing comprehensive services and expertise to support product development of large and small molecules, novel compounds and generics. Three clinical pharmacology facilities have been designed to meet both standard and specialized study designs. Two bioanalytical facilities specialize in small molecule analysis. A full range of scientific affairs services, including PK/PD, biostatistics, data management and medical writing provide analytical support to take projects from start to finish.
Scope of services
With three clinical sites across North America and 30 years of clinical pharmacology experience, PRACS is the clinical pharmacology expert. Our clinical pharmacology study experience includes first-in-human, proof-of-concept, drug-drug interaction, bioavailability, bioequivalence, PK/PD and Thorough QT studies.
The experienced R&D team at PRACS can develop and validate methods, or transfer your method to our laboratories. With more than 30 LC/MS/MS and two laboratories in North America, we offer method development, transfer and validation; and LC-MS/MS services.
PRACS offers a full range of scientific affairs services to support your early phase drug development program from initial study design to final reports. These services include study design, protocol development, biostatistics, data management and medical writing.
Therapeutics and Specialty Areas
PRACS offers a suite of cardiac safety services that provides you with the ability to accurately evaluate the potential for unintended effects of drugs on the heart. With an impressive track record of conducting more than 55 TQT trials since 2005, PRACS is your cardiac safety specialist.
Environmental Exposure Chambers
The Environmental Exposure Chambers (EECs) are a validated, rapid and FDA-accepted clinical solution for the development of small molecule drugs, immunotherapies and therapeutic devices. Our six chambers are ideal for a broad range of indications within the respiratory, immunology and ophthalmic areas.
Dermal and Transdermal
The PRACS dermatology team offers comprehensive in vitro and in vivo bioavailability, bioequivalence and safety testing services, from preclinical formulation assessments to early phase human studies, for both topical products and transdermal delivery systems. Our extensive experience spans the successive stages of product development, pharmacokinetic, safety and claims testing.