Industry-Leading Phase 1 Clinical Development Capabilities
Moving quickly and safely through phase I trials is critical to successfully carrying out the clinical phase of development. Our Phase 1 research facilities feature more than 700 beds across eight strategically located facilities on three continents.
QPS is well known for its success in first-in-human clinical trials. All phase I sites are staffed by expert clinical pharmacology teams that routinely conduct hundreds of phase I/IIa studies annually. We also have scientific expertise in the design of all types of phase I studies (formerly referred to as “first-in-man” studies), including dose response, SAD, and MAD studies, as well as the interpretation of study data.
We specialize in conducting proof-of-concept (POC) studies in special and patient populations. Our proof-of-concept studies help ensure a study’s safety and value and prevent resources from being wasted on targets and molecules that aren’t likely to succeed. When well designed and properly conducted, proof-of-concept studies establish the basis for large-scale dose response, efficacy, and safety studies that will assess efficacy, tolerability, side effects, and associated risks.
Our Early Phase Clinical Trial Sites:
- 58 beds in Groningen, the Netherlands
- 138 beds in Hyderabad, India
- 8 beds in Leeuwarden, the Netherlands
- 95 beds in South Miami, Florida, USA
- 240 beds in Springfield, Missouri, USA
- 60* beds in Suzhou, China
- 40 beds in Taipei, Taiwan
- 100* beds in Taizhou, China
*Alliance Partners
In addition to one of the world’s largest phase I site offerings, we provide fully integrated services to seamlessly move your project from first-in-human clinical trials through early clinical development. QPS’s large, global bioanalytical labs support this early phase clinical study work by defining pharmacodynamic endpoints and developing laboratory biomarker assays for the evaluation of your early stage compounds, targeted for a wide variety of therapeutic indications.
Our expert staff uses disciplined processes to supply accurate, superior-quality data so you can make confident decisions – earlier and faster.
FULL-SERVICE EARLY PHASE CLINICAL OFFERINGS
- Study Design and Protocol Writing
- Regulatory Support
- Data Management, Statistics & Pharmacokinetics, and Medical Writing
- Bioanalysis/Biomarker Assays/Genotyping
- Bioanalysis/Biomarker Assays/Genotyping
- On-site PBMC Processing and FACs Analysis
- Pharmacy and Compounding Capabilities
- First-in-Man Programs (SAD + MAD + FE + gender)
- Dose Response Studies
- Dermal and Transdermal Studies
- Clinical PK/PD Studies
- BE/BA Studies
- Vaccine Studies
- Proof-of-Concept Studies
- Drug-Drug Interaction Studies (CYPs and Transporters)
- 505(b)(2) NDA Studies
- Human Mass Balance Studies
- Microdosing Studies
- Imaging (PET, fMRI) Studies
- Thorough QT/QTc Studies