Clinical Pharmacology Expertise at Quotient Sciences
Your partner in providing integrated
first-in-human & clinical pharmacology programs that reduce time and complexity in bringing new drugs to market.
Quotient Sciences is focused on seamlessly delivering your Phase I, healthy volunteer trials with the highest degree of quality. We're here to help you make critical decisions earlier as you're accelerating from first-in-human (FIH) to proof-of-concept (POC).
Our Expertise
- Proven track record spanning 30 years
- More than 1,300 Phase I studies completed
- Experts in FIH studies
- Industry-leading Phase I medical directors
- Ability to rapidly recruit large groups of volunteers
- Fully integrated programs led by experienced project managers
- In-house data sciences team
- On-site pharmacy compounding & integrated real-time adaptive GMP manufacturing capabilities
Our Study Types Include
- FIH single ascending dose (SAD)
- FIH multiple ascending dose (MAD)
- Relative bioavailability/pharmacokinetics
- Drug-drug interaction (DDI)
- Food effect
- Thorough QT (TQT)/cardiac safety
- Bioequivalence
- Biosimilars
- 14C ADME/mass balance
- Isotopic labeling
- Gamma scintigraphy
- Pharmacodynamics/biomarkers
- Japanese bridging
A trusted team to help you accelerate your programs
- Purpose-built Phase I clinical units in the US (Miami, FL) & UK (Nottingham)
- 229 beds globally
- Experienced team of 16 physicians and principal investigators
- Database of more than 25,000 healthy volunteers
- UK Medicines and Healthcare products Regulatory Agency (MHRA)- and US Food and Drug Administration (FDA)-inspected facilities
- Industry-leading US Institutional Review Board (IRB) and UK Clinical Trial Authorization (CTA) approval timelines
- Dedicated program managers will provide you with full project oversight and third-party management.
- Formulation development for all dosage forms, including oral solutions and suspensions, capsules and tablets, sterile preparations (intravenous [IV] and subcutaneous [SC]), inhaled and nasal devices, topical creams and gels
- Early-phase data sciences group providing full-service data management, statistics, and medical writing
- Regulatory support to ensure a seamless FDA or MHRA submission and approval process for clinical trial applications
Download our info sheet to learn more about our capabilities.
Take a virtual tour of our clinical pharmacology facility in Miami, FL
Watch Our Latest Webinar
Human ADME Q&A Roundtable:
Leveraging a Synthesis-to-Clinic® Approach to Rapidly Support Regulatory Approval
Approaching the end of your Phase II milestone & gearing up for phase III and beyond? For most drug programs, a key step for inclusion in a successful global regulatory filing is to conduct a 14C human ADME study. In our latest webinar, Iain Shaw, Sr. Director of 14C Drug Development at Quotient Sciences, along with a panel of experts from our drug development, radiosynthesis and clinical pharmacology teams discuss efficient ADME study design, common challenges that can occur and mistakes to avoid, and how human ADME studies can improve decision making at critical drug development milestones.