Industry-Leading Phase I Clinical Development Capabilities
Moving quickly and safely through Phase I trials is critical to successfully carrying out the clinical phase of development. The QPS Phase I research facilities feature more than 500 beds across four 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:
- 240 beds in Springfield, Missouri, USA
- 106 beds in South Miami, Florida, USA
- 138 beds in Hyderabad, India
- 40 beds in Taipei, Taiwan
- Additional site partnerships across Australia, Europe and the USA
In addition to >500 Phase I patient beds around the world, QPS has established partnerships with a large number of early phase clinics and late phase clinical trial sites in the USA, the EU and Australia. A few of these sites exclusively run Phase I-II oncology trials and have deep experience with running these challenging studies. If you choose to run your study in Australia, there are some additional potential benefits, such as shorter timelines and a research tax credit for smaller biotech companies. QPS can connect you with a consulting company to learn more, while we discuss your potential project.
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
- 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
Links to Relevant Documents
- Clinical Trials in Special Populations
- Early Phase Clinical Overview
- Expedited Study Delivery – Logistics
- Expedited Study Delivery – Pharmacy
- Studying Sedatives in Phase I Studies
- Pharmacokinetic Studies in Patients
- 2021 QPS NL Clinical Study Infographic
- Selecting the Location of a Phase I Clinical Trial in the EU
- Cerebrospinal Fluid (CSF) Sampling
- QPS Negative Pressure Room
- CNS Drug Development
- Influenza Vaccine Case Study
- Clinical Trial Complexity in a Pandemic Case Study
- Corporate Overview Clinical Sites
