Clinical Research
Clinical Research Overview
Initiating the study of a compound’s effects in humans is the first step in generating the required data for a New Drug Application (NDA).
QPS provides full integrated phase 1 services starting from protocol development, patient stratification/genotyping, clinical conduct, bioanalysis, data management/statistical analysis, PK/PD modeling and medical report writing.
QPS Bio-Kinetic is an early-phase clinical research facility headquartered in Springfield, Missouri. Established as Bio-Kinetic Clinical Applications in 1994 by Dale Bourg and David Koenigsfeld, QPS Bio-Kinetic began operations in a small, 12-bed facility with only a few key team members. Today, we offer clients a 240-bed state-of-the-art clinical research facility, an extensive database of healthy volunteers in a rich recruiting environment and a highly-skilled and experienced staff using disciplined processes to give you the highest accuracy and data integrity.
QPS can conduct the following clinical studies to support an application for marketing approval:
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Single and multiple-dose safety, tolerability and pharmacokinetic
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Drug/drug interaction
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Bioequivalence/bioavailability
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Food effect
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Pharmacokinetics/pharmacodynamics
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Formulation assessment
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Special population
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Gender
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Safety pharmacology (QTc interval, GI motility, etc.)
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Mechanistic
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Enzyme inhibition/induction
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CYP profiling
Beyond these services, QPS Bio-Kinetic has other unique offerings such as:
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Recruitment speed: We can enroll large panels of subjects faster than most other sites
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Unparalleled success recruiting postmenopausal studies full, with a database of over 2,400
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Conduct large group cardiac safety studies (TQTc)
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Extensive experience with vaccine studies, completing thousands of subjects in 24 studies over the last 5 years
QPS can offer services covering clinical/bioanalysis/biomarker, as well as a full clinical package. Click on the link to have a brief look at the process maps.
