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PRACS Institute

Description: 

PRACS – Innovative, Flexible, Dedicated Industry Leaders

Corporate description

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

 

Clinical Pharmacology

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.

 

Bioanalytical

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.

 

Scientific Affairs

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

 

Cardiac Safety

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.

 

Services: 

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

Contact Information: 

PRACS Institute
4801 Amber Valley Parkway
Fargo, ND, 58104, USA
Phone : 8777238376
Fax : 7012394955
Internet : www.pracs.com
Email : info@pracs.com
Contact Person : Katherine Cloninger