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Validated Assays

Early Stage Clinical Development

 

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 fully 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.

 

Today, we offer clients access to four highly experienced Phase I sites around the globe, all having extensive databases of healthy volunteers in rich recruiting environments and employing 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:

• First-in-Man: single and multiple-dose safety, tolerability and pharmacokinetic
• Drug/drug interaction
• Bioequivalence/bioavailability
• Food effect
• Pharmacokinetics/pharmacodynamics
• Formulation assessment
• Special population
• Gender
• Safety pharmacology (QTc interval, GI motility, etc.)
• Mechanistic
• • Enzyme inhibition/induction
• CYP profiling
• Human Mass Balance
• Microdosing • Vaccine
• Imaging (PET, fMRI)

 

PDF Download: QPS Early Stage Clinical Research Overview