PRACS Institute is a leading early-phase contract research organization.
A pioneer in the eary phase research space, PRACS Institute has conducted more than 20,000 clinical pharmacology studies, more than any other CRO. With facilities across North America, PRACS offers flexible, quality clinical development services in a range of therapeutic areas, including asthma and allergy, dermatology and diabetes, as well as bioanalytical services to support clinical, preclinical drug and biomarker analysis for small and large molecules.
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1-10 employees
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Research
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4801 Amber Valley Parkway,Fargo,ND,US
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1983
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Medical Writing, Biostatistics, Dermatology, Data Management, Bioavailability, Lc/Ms/Ms, Asthma, Allergy, Pk/Pd, Bioanalytical, Scientific Affairs, Central Lab, Fih, Tqt, Franz Cell, 400+ Assays, Accelerated Poc, Interaction Studies
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The decision makers in Cetero Research are Alex Walker, Gilbert Weiner, Janna Chambers, etc. Click to Find Cetero Research decision makers emails.
PRACS Institute specializes in early-phase clinical studies, particularly in clinical pharmacology. They have extensive experience conducting a wide range of studies, including First-in-Human (FIH) trials, Thorough QT (TQT) studies, and bioavailability assessments. With a portfolio of over 20,000 clinical studies, they are equipped to handle various therapeutic areas, including dermatology, asthma, and allergy.
PRACS Institute provides comprehensive data management services that include data collection, validation, and analysis. Their team utilizes advanced statistical methods and biostatistics expertise to ensure the integrity and accuracy of study data. Additionally, they employ robust data management systems that facilitate real-time data access and reporting, ensuring compliance with regulatory requirements.
PRACS Institute offers a wide range of bioanalytical services, including LC/MS/MS analysis for pharmacokinetic (PK) and pharmacodynamic (PD) studies. They have the capability to conduct over 400 assays, ensuring precise quantification of drug concentrations in biological samples. Their bioanalytical team is experienced in method development and validation, providing reliable results that meet regulatory standards.
The Scientific Affairs team at PRACS Institute plays a crucial role in ensuring that all clinical studies are designed and executed according to the highest scientific and regulatory standards. They provide strategic guidance on study design, protocol development, and regulatory submissions. Their expertise helps clients navigate the complexities of clinical research and ensures that studies are aligned with industry best practices.
Yes, PRACS Institute offers medical writing services that encompass the preparation of clinical study protocols, investigator brochures, and clinical study reports. Their team of experienced medical writers collaborates closely with clients to ensure that all documentation is clear, concise, and compliant with regulatory requirements. This service is essential for facilitating successful submissions to regulatory authorities.
PRACS Institute serves a diverse range of industries, primarily focusing on pharmaceutical and biotechnology companies. Their expertise spans various therapeutic areas, including dermatology, respiratory diseases, and allergy treatments. By providing specialized services tailored to the needs of these industries, PRACS Institute supports clients in bringing innovative therapies to market efficiently and effectively.
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