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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.

  • 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 leading Phase 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

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

Resources

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