How do I find an integrated solution for first-in-human and clinical pharmacology programs?
Quotient is your answer.
Clinical Pharmacology
When you are looking for a partner who is dedicated to Phase I trials and early clinical development, rely on Quotient Sciences for the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier and faster. Whatever Phase I clinical pharmacology study you require, you can expect a fully integrated program from study design and startup to data reporting.
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Proven track record spanning 30 years
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>1,300 Phase I studies completed
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Experts in first-in-human (FIH) and drug-drug-interaction (DDI) studies
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Industry leading Phase I medical directors -
Ability to rapidly recruit large cohorts of volunteers
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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
Benefit from dedicated study resources
Quotient has the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. If you need a fully integrated solution including data management, data analysis, statistics and medical writing, Quotient is your answer.
- 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)
- DDI
- Food effect
- Thorough QT (TQT) / cardiac safety
- Bioavailability, dose proportionality and absolute bioavailability
- Bioequivalence
- Biosimilars
- 14C ADME / mass balance
- Proof-of-concept
- Pharmacodynamics / biomarkers
- Japanese bridging
Special populations
- Healthy participants
- Ages 65 and older
- Post-menopausal
- Male and female infertility
- Hypertensive
- Type II diabetics
- Asthma and allergic rhinitis
- Obese
- Healthy smokers
- Gastrointestinal diseases
- Japanese
Partner with us to develop your integrated early drug development program
Ready to accelerate your molecule from FIH to proof of concept?
Quotient is your answer.
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Human ADME
How can I simplify the delivery of my human ADME study? Quotient is your answer.
Explore Our Human ADME Capabilities -
Regulatory affairs
How do I ensure high-quality regulatory submissions? Quotient is your answer.
Access Our Regulatory Capabilities -
Data Sciences
How do I access expert data services for my clinical pharmacology studies? Quotient is your answer.
Discover Our Data Sciences Services -
Modeling and Simulation
How do I enhance my clinical development program using modeling and simulation? Quotient is your answer.
Explore Our Capabilities -
Gamma Scintigraphy Imaging
How do I design and conduct my scintigraphic studies?
Learn more
Resources
Learn more about clinical pharmacology
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Fact Sheet
Clinical Pharmacology
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.
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Webinar
Tufts CSDD Study Assessing the Financial Benefits of Translational Pharmaceutics®: A Platform for Accelerating Product Development
This webinar will summarize the key findings of the recent Tufts CSDD research into Translational Pharmaceutics, the innovative approach to drug development. It demonstrates significant time savings of >12 months and financial gains of >$100 million per drug approved.
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Scientific Posters
AAPS 2019 Poster- Applications and Benefits of Healthy Volunteer Trials to Accelerate Oncology Drug Development
Presented at AAPS 2019: Phase I drug development for oncology compounds is traditionally conducted directly in patient populations. Oncology molecules have historically been cytotoxic, meaning their safety and risk:benefit profile makes them unviable for dosing in healthy subjects. While this ensures reduced nonclinical requirements, rapid access to patient data and an earlier assessment of efficacious potential, it can also present challenges. For example, patients recruited in Phase I trials typically are at end of life care and will be taking multiple co-medications and have multiple co-morbidities (e.g. liver and kidney function may vary greatly among the recruited subjects). Practically, recruiting patients into Phase I studies can also be problematic, requiring multiple clinical sites and protracted recruitment times for what would traditionally be single site, quickly recruited healthy volunteer studies.
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Scientific Posters
AAPS 2019 Poster- Comparison of Two In-Silico Modeling Programs, ADMET Predictor® and Percepta® to Predict Intrinsic Solubility and pKa of Poorly Soluble Drugs
Presented at AAPS 2019: Aqueous solubility is a prerequisite for oral absorption of a drug and the pH-dependence of aqueous solubility is critical information to guide formulation development strategies. The purpose of this study was to evaluate the physical property modules in two commercially available in-silico modelling programs in predicting the pH solubility profiles as described by the ionization constant (pKa) and the intrinsic solubility of the unionized form.