How do I find an integrated solution for first-in-human and clinical pharmacology programs?
Quotient is your answer.
Proven track record spanning 30 years
>1,300 Phase I studies completed
Experts in first-in-human (FIH) and drug-drug-interaction (DDI) studies
Industry leadingPhase I medical directors
Ability to rapidly recruit large cohorts of volunteers
Fully integrated programs led by experienced project managers
Dedicated to your Phase I study
- Purpose-built Phase I units in U.S. and U.K.
- 245 beds globally
- Experienced team of 16 physicians and principal investigators
- Database of >25,000 healthy volunteers
- MHRA- and FDA-inspected facilities
- Industry-leading U.S. IRB and U.K. CTA approval timelines
- Clinical pharmacology expertise including FIH (SAD/MAD), DDI, food effect and ADME experience
- Experienced project managers guiding your study to successful on-time delivery, within budget and to the highest quality
- On-site pharmacy compounding and integrated real-time adaptive GMP manufacturing
- Formulation development for all dosage forms including oral solutions and suspensions, capsules and tablets, sterile preparations (IV and 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
Experience and study types
- FIH (SAD/MAD)
- Food effect
- Thorough QT (TQT) / cardiac safety
- Bioavailability, dose proportionality and absolute bioavailability
- 14C ADME / mass balance
- Pharmacodynamics / biomarkers
- Japanese bridging
- Healthy participants
- Ages 65 and older
- Male and female infertility
- Type II diabetics
- Asthma and allergic rhinitis
- Healthy smokers
- Gastrointestinal diseases
How can I simplify the delivery of my human ADME study? Quotient is your answer.Learn more
How do I ensure high-quality regulatory submissions? Quotient is your answer.Learn more
How do I access expert data services for my clinical pharmacology studies? Quotient is your answer.Learn more
Modeling and Simulation
How do I enhance my clinical development program using modeling and simulation? Quotient is your answer.Learn more
When you are looking for a partner who is dedicated to Phase I trials and early development, rely on Quotient Sciences. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier.
PBPK Modelling & Simulation
Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies.
Application of a Novel ‘Make and Test in Parallel’ Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects
GDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers.
An Open-label, Two-period Study Designed to Evaluate and Compare the Mass Balance Recovery and Metabolite Profile of 14C-Deutetrabenazine and 14C-Tetrabenazine in Healthy Male Subjects
Deutetrabenazine (Austedo, Teva) is approved for the treatment of chorea associated with Huntington’s disease (HD) and tardive dyskinesia (TD). Deutetrabenazine is the first deuterated product approved by the FDA and only the second product approved in HD and TD. Deutetrabenazine is a novel VMAT2 inhibitor that is structurally related to tetrabenazine, with two trideuteromethoxy groups at the 9- and 10-positions in tetrabenazine