EARLY STAGE CLINICAL DEVELOPMENT …
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 six highly experienced Phase I sites around the globe, all having extensive databases of (patient) 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 \
- Food effect
- Pharmacokinetics/pharmacodynamics (RAC)
- Formulation assessment
- Special population
- Safety pharmacology (QTc interval, GI motility, etc.)
- Enzyme inhibition/induction
- CYP profiling
- Human Mass Balance
- Imaging (PET, fMRI)
For more information, please visit our website: www.qps.com or contact us by e-mail: firstname.lastname@example.org.