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
Project management plays a major role in our clinical programs at Quotient Sciences. With each clinical trial, there are many moving parts and our project managers strive to operate with agility and flexibility in order to successfully deliver projects on-time and on-budget, helping to get new medicines to patients faster. Quotient Project Management will provide end-to-end support from concept and project scoping, to project delivery. We will adapt along with your clinical trial to ensure your needs and the needs of your program are continuously met, manage and mitigate any risks that may arise and provide you with recommendations for the next stage in development. Our project managers make communication a priority by actively listening to what is important to you and delivering the results of your trial openly and honestly. We actively encourage open discussion, feedback and criticism, in order to ensure the best outcome for all. For more information about Quotient Project Management, click here.
- 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
Quotient's Clinical Pharmacology Facilities
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
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
How can I simplify the delivery of my human ADME study? Quotient is your answer.Explore Our Human ADME Capabilities
How do I ensure high-quality regulatory submissions? Quotient is your answer.Access Our Regulatory Capabilities
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
Integrating Pharmacy Compounding and GMP Manufacturing
Accelerate through First-in-Human Testing and Seamlessly Supply Drug Product into Patient TrialsLearn 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.
Strategies for Accelerating the Development of Modified Release Oral Forms
MR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.
Accelerating the Developing of Orphan Drugs for Rare Diseases
Worldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.
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 pipeline. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review. 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.