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
Quotient's Clinical Pharmacology Facilities
Nottingham, UK
Quotient Sciences Nottingham facility is the centre of excellence for Translational Pharmaceutics®. All formulation development, analytical, manufacturing and clinical studies are highly integrated across the 4 adjacent buildings to enable rapid delivery of Translational Pharmaceutics programs. Our clinical pharmacology unit capabilities include:
- 85 bed FIH/Clinical Pharmacology Unit
- 14C Radiolabelled Studies
- Inhaled Dosage Forms & Clinical Assessment
- Scintigraphy Capabilities
- Laboratory Experience with Pharmacodynamic PBMC Assessments
- Large Healthy Volunteer Database
Miami, FL
Quotient Sciences Miami possesses a team that's experienced in a wide range of clinical pharmacology studies including first-in-human, drug-drug interaction, bioavailability and pharmacokinetic assessments. Our new, state-of-the-art compounding pharmacy supports the rapid and cost-effective preparation of dosage forms including oral solutions, suspensions, drug or powder in capsule or bottle, and sterile preparations. Clinical studies conducted at our Miami site can be fully integrated with Quotient’s formulation development and GMP manufacturing activities, enabling the delivery of US based Translational Pharmaceutics programs, saving clients on average 12 months of development time and millions of dollars in R&D costs.
- Purpose Built 144 Bed Clinical Pharmacology Unit
- First-in-Human Programs
- Integrated Compounding Pharmacy Capabilities
- Oral and Parenteral Dosage Forms
- Translational Pharmaceutics®
- Regulatory Driven Clinical Pharmacology Studies
- Onsite CLIA Certified Clinical Laboratory
- Extensive Laboratory Experience with Pharmacodynamic PBMC Assessments
- Large Healthy Volunteer Population/Rapid recruitment
Quotient Sciences Miami Facility
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?
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Integrating Pharmacy Compounding and GMP Manufacturing
Accelerate through First-in-Human Testing and Seamlessly Supply Drug Product into Patient Trials
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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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Whitepaper
Accelerating the Developing of Orphan Drugs for Rare Diseases
A rare disease is defined as one affecting less than 200,000 people (in the US) or no more than five in 10,000 of the general EU population. There are approximately 7,000 rare diseases, affecting an estimated 30 million people in each of the US and EU. Worldwide there are over 300 million people living with one or more identified rare diseases representing 3.5% - 5.9% of the global population. The development of new treatments to address these unmet clinical needs clearly represents an important global health priority.
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Whitepaper
Accelerating the Development of Oncology Medicines
Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline1. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review2. Given the number of molecules in development, there is increasing pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.
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Fact Sheet
Project Management at Quotient Sciences
Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.