High-quality clinical pharmacology studies, delivered safely and quickly
Comprehensive Phase 1 clinical pharmacology studies that offer the insight you need.
Quotient Sciences offer comprehensive clinical pharmacology services for exploratory and regulatory-driven studies. Our end-to-end services encompass expert clinical study design, thorough data analysis, and detailed reporting. With our fully integrated approach, we ensure seamless execution and deliver high-quality results safely and quickly.
- A full range of clinical pharmacology programs
We apply our extensive clinical and medical experience to conduct exploratory studies, and studies for registration and product labeling, including DDI, human ADME, BA/BE, and more. These can be run individually or as part of a package to streamline your clinical testing.
Additionally, our integrated services including bioanalysis, PK, and data sciences enable rapid data turnaround and reporting.
- Access to healthy volunteers and special populations in the US and UK
Our dedicated volunteer management team are able to quickly find and recruit healthy volunteers and special populations, such as healthy smokers, healthy elderly, high BMI, or post-menopausal women for your phase 1 study.
- Trusted experience that puts you in control
Our goal is to keep your clinical study on-course, while always keeping volunteer and patient safety in mind. Programs are led by experienced project management and medical staff, with scientific and regulatory support.
Your path through clinical development
Trust Quotient Sciences for the support needed to deliver your clinical programs, safely and reliably.
Clinical services
- Clinical trial design & clinical conduct
- Project management
- Medical writing (synopsis, protocol, ICF)
- Regulatory submissions and management
- Volunteer recruitment and screening
- Pharmacy compounding
- Data sciences
- Pharmacokinetics
- Statistics
- Clinical programming & statistical programming
- Vendor management & quality oversight
Clinical study types
- Human ADME studies
- Drug-drug-interaction studies
- Cardiac monitoring & thorough QT
- Bioavailability & pharmacokinetics
- Bioequivalence
- Biosimilars
- Pharmacodynamic & biomarker
- Food effect studies
- Microdose & microtracer
- Ethnobridging
Special populations
- Healthy volunteers
- Healthy elderly
- Post-menopausal women
- Women taking oral contraception
- Men and women of non-child-bearing potential
- Healthy obese (high BMI)
- Healthy smokers
- Japanese and Chinese
Purpose-built Phase I units, dedicated to the success and safety of your study.
Ensuring the safety of trial participants while mitigating risk are critical in clinical research.
Our purpose-built Phase I units in Miami, FL and Nottingham, UK are FDA- and MHRA-inspected, with trained staff to ensure the success and safety of your clinical program.
We provide 24/7 resident medical cover on a risk-assessed basis, and both clinical units are located in close proximity to University Hospital Emergency Departments. Additionally, our Nottingham unit has supplementary Phase I accreditation—the highest safety rating for the conduct of higher risk studies in the UK.
With a high number of experienced full-time physicians and an extended clinical team of licensed personnel, nurses, and technicians, we keep volunteer safety as our focus.
A clinical pharmacology study in early development involves the study of drugs in either healthy volunteers or small cohorts of patients (Phase 1, 1b, 2a).
The aim of these studies is to assess the safety, tolerability, pharmacokinetics and pharmacodynamic response to inform the next stage patient studies.
At Quotient Sciences, our clinical pharmacology services cover all aspects of these trials, from trial design through to final reporting.
We can support all study types including first in human (FIH; including SAD/MAD), relative bioavailability (BA) / pharmacokinetics (PK), bioequivalence (BE), biosimilars, pharmacodynamic (PD) / biomarker, food effect (FE), drug-drug interaction (DDI), cardiac monitoring/Thorough QT (TQT), human ADME, microdose/microtracer, and ethnobridging (Japanese and Chinese).
Many different functions and a range of expertise are required to successfully deliver a clinical pharmacology trial in early development.
At Quotient Sciences, our expertise covers all aspects from the initial trial design through to final reporting, with the entire program managed by our skilled Project Managers.
We provide all required services including trial design, medical writing, regulatory submission, participant recruitment and screening, and clinical conduct.
Drug product is managed in either our GMP suites at our Nottingham facility, or using our pharmacy compounding services at our Miami, FL CRO facility.
Our expertise extends to data management, pharmacokinetics, and statistical analysis, including clinical and statistical programming using our in-house team.
Additionally, we provide vendor management and ensure quality oversight throughout the entire process to guarantee successful trial execution and compliance.
From facilities located in the US and UK, Quotient Sciences offers coordinated contract research, development, and manufacturing services (CRO services and CDMO services) as part of one organization.
Phase I clinical testing and clinical pharmacology services are done from facilities in Nottingham, UK and Miami, FL.
Contract research and manufacturing services are often separate services. Simply put, a company that offers CRDMO services integrates different areas that would typically be found by selecting multiple vendors.
A CRDMO offers a contract research, development, and manufacturing as part of one organization.