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 (RAC)
  • 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)

Early Stage Clinical Development Leadership Team

Howard I. Schwartz
Howard I. Schwartz
Chief Medical Officer
Wim Tamminga
Wim Tamminga
Vice President and Global Head of Early Phase Clinical
P
Paul Lehman
Vice President of Dermal and Transdermal Research Services
Radjagobal Radakichenane
Radjagobal Radakichenane
General Manager – Clinical Operations
Mark A. Slama
Mark A. Slama
Vice President and General Manager, QPS Bio-Kinetic

Phase I Clinics

With six highly experienced Phase I sites established around the globe, QPS is a true global leader in early stage clinical research services. QPS Clinical Pharmacology Teams routinely conduct hundreds of Phase I/IIa studies annually. QPS provides you with one of the world's largest Phase 1 site offerings with more than 500 Phase I beds on three continents:

  • 58 in Groningen, The Netherlands
  • 40 in Taipei, Taiwan
  • 92 in Hyderabad, India
  • 240 in Springfield, Missouri, USA
  • 75 in South Miami, Florida, USA
  • 20 in Hollywood, Florida, USA

Proof of Concept Studies

For Proof of Concept (POC) studies in patient populations, QPS works together with local university and general hospitals.

QPS can measure a wide range of pharmacodynamic endpoints and laboratory biomarker assays that are critical to your early stage studies for the evaluation of compounds targeted for a wide variety of therapeutic indications including but not limited to:

  • Adrenal/Pituitary Disorders
  • Allergy
  • Alzheimer's Disease/CNS Disorders
  • Anemia
  • Asthma/COPD
  • Bone Disease/Metabolism
  • Cardiac MarkersCell Response Reproductive Endocrinology
  • Diabetes/Obesity/Lipid Metabolism/Carbohydrate Metabolism
  • Female Health Care/Gynecological Endocrinology
  • Gastrointestinal
  • Hemostasis/Angiogenesis
  • Immunology/Autoimmune Disease/Rheumatoid Arthritis
  • Infectious Disease
  • Inflammation/Immune Status/Cell Response
  • Phenotypic Markers of Drug Metabolism
  • Renal Function
  • Thyroid Function
  • Tumor/Neoplasia Markers

PK/PD Modeling

As part of Phase I integrated services or as a stand-alone service, QPS provides clinical PK or PK/PD data analyses with either non-compartmental PK methods using WinNonlin and SAS software applications, or population PK or PK/PD modeling using NONMEM, SAS and other associated software applications.

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