Clinical Pharmacology
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 (FIH) to proof of concept (POC), helping you make critical decisions earlier. Whatever clinical pharmacology study you require, you can expect a fully integrated program, from study design to data reporting.
Experience and study types
- FIH (single ascending dose [SAD]/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
- POC
- Pharmacodynamics/biomarkers
- Japanese bridging
Our expertise
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Proven track record spanning 30 years
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More than 1,300 Phase I studies completed
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Experts in FIH studies
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Industry-leading Phase I medical directors
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Ability to rapidly recruit large groups of volunteers
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Fully integrated programs led by experienced project managers
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In-house data sciences team
Dedicated to your Phase I study
- Purpose-built Phase I units in the US and UK
- 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
Project management
Your dedicated early-phase project manager will provide you with a customized service and third-party management/oversight. We deliver full-service programs on time, within budget, and to the highest quality to meet your rigorous requirements and those of the regulatory agencies. For more information about Quotient Sciences Project Management, click here.
Benefit from dedicated study resources
Quotient Sciences 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 Sciences 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 Good Manufacturing Practice (GMP) manufacturing
- 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
Special populations
- Healthy participants
- Ages 65 and older
- Post-menopausal
- Male and female infertility
- Hypertensive
- Type II diabetics
- Asthma
- Allergic rhinitis
- Obese
- Healthy smokers
- Gastrointestinal diseases
- Japanese
Quotient Sciences' clinical
pharmacology facilities
Nottingham, UK
- Over 650 Phase I studies completed
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Clinical unit with a dedicated 14C ADME ward and laboratory
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On-site pharmaceutical laboratories and GMP manufacturing
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9,000 active healthy volunteers in our database
- 45 Phase I CTA submissions annually (more than any other UK unit)
Miami, USA
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Over 650 Phase I clinical studies completed
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144-bed clinical unit with dedicated FIH wards
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On-site pharmacy, with clean rooms for aseptic products
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19,000 active healthy volunteers in our database
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Recruitment for special subject populations
Partner with us to develop your integrated early drug development program
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First in human (FIH) to proof of concept (POC)Accelerating molecules to POC
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Human ADMEHow can I simplify the delivery of my human ADME study?
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Regulatory affairsHow do I ensure high-quality regulatory submissions?
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Modeling and simulationWe can help you pinpoint the question you need to answer and identify the data you need to collect to enhance your clinical development program.
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Integrating Pharmacy Compounding & GMP ManufacturingAccelerate through first-in-human testing and seamlessly supply drug product into patient trials.
Resources
Learn more about clinical pharmacology
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Info SheetClinical PharmacologyWhen 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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Scientific PostersClinical Pharmacokinetics and Pharmacodynamics of ME-401 - AACR 2016Clinical Pharmacokinetics and Pharmacodynamics of ME-401, an Oral, Potent and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ, Following Single Ascending Dose Administration to Healthy Volunteers
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WebinarUpcoming Webinar: Strategies for Achieving Regulatory Milestones FasterSave your spot for our next webinar featuring a customer case study from Ensysce Biosciences on April 19, 2023. Dr. Vanessa Zann, Senior Drug Development Consultant, will be joined by Lynn Kirkpatrick, CEO of Ensysce Biosciences for this special presentation.
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WebinarUpcoming Webinar: Quotient Sciences and Charles River Collaboration WebinarJoin experts from Quotient Sciences & Charles River for a webinar taking place on 18 May, "Integrated Strategies for Accelerating from Discovery to IND and Beyond: Charles River & Quotient Sciences Collaboration."
What Our Clients Say
"Quotient have a very valuable experience in conducting radiolabeled studies with microtracer technique and are open to customer requests and advice."
-Sanofi