Integrated first-in-human and clinical pharmacology programs

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.

Employee at Quotient Sciences explaining the process of clinical trials to a volunteer

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

  • Proven track record spanning 30 years
  • More than 1,300 Phase I studies completed
  • Experts in FIH studies

  • Industry-leading Phase I medical directors
  • Ability to rapidly recruit large groups of volunteers
  • Fully integrated programs led by experienced project managers
  • 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
  • Clinical unit with a dedicated 14C ADME ward and laboratory

  • On-site pharmaceutical laboratories and GMP manufacturing

  • 9,000 active healthy volunteers in our database

  • 45 Phase I CTA submissions annually (more than any other UK unit)

Miami, USA

  • Over 650 Phase I clinical studies completed

  • 144-bed clinical unit with dedicated FIH wards

  • On-site pharmacy, with clean rooms for aseptic products 

  • 19,000 active healthy volunteers in our database

  • Recruitment for special subject populations

Quotient Sciences' Miami clinical pharmacology facility

What Our Clients Say

"Quotient have a very valuable experience in conducting radiolablled stuies with microtracer techniue and are open to customer requests and advice."

-Sanofi

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