Early Clinical Development Services

Make critical decisions earlier with the help of truly flexible, integrated programs. Learn about our expertise in clinical pharmacology, first-in-human to proof-of-concept trials, and more.

High-quality results. Delivered with confidence.

Seamless execution and high-quality results for your early clinical programs.

Dedicated to Phase I trials and early drug development, Quotient Sciences can help accelerate your molecule to your first-in-human and proof of concept milestones. 

We are focused on delivering the insight you need by offering end-to-end services to manage every aspect of your early clinical program. Our experience spans more than 30 years with more than 1,300 Phase I studies delivered at our clinical units in Miami and Nottingham

Whether you are looking for expert clinical study design to achieve your FIH trial, are needing to bridge from FIH to POC trials, or are conducting exploratory and regulatory studies such as DDI and human ADME trust Quotient Sciences for the support needed to deliver your programs, safely and reliably. 

Clinical Pharmacology Fact Sheet
Join us for our next webinar
 

1,300+ Phase 1 Studies

delivered across the last 30 years at our dedicated Phase I clinical units in Miami, FL and Nottingham, UK.

Join us for our next webinar  
 

Database of 31,500+

active healthy volunteers, supported by dedicated recruitment and screening teams at each of our clinics. We are able to also recruit for special populations and patient groups across all therapeutic areas.

Join us for our next webinar
 

99% of our studies

start on time, 98% enroll with full cohorts, and 99% of our subjects are retained throughout.

Upcoming webinar - October 14
Live Webinar: From First-in-Human to Proof-of-Concept — Quicker, Smarter, Streamlined
  • Industry-leading project management

Each project manager leads a matrix team that integrates functions, sites, and stages of development. They are all committed to forming strong partnerships, putting you at the center of how we deliver every project. 

Our experienced project management team is one of the key reasons why over 90% of our customers say they plan to work with us again in the future.

  • Seamless delivery of complex protocols

Our clinical pharmacology programs are led by experienced scientific, medical, and project management teams. 

We advise on your optimal design, leveraging extensive knowledge of how to deliver across complex protocols, including multi-part, flexible, and umbrella designs with both healthy volunteer and patient cohorts. This approach ensures seamless execution and delivery of high-quality clinical results.

  • Rapid recruitment of healthy volunteers, special populations, and select patient groups

Our volunteer-centric approach helps us maintain a high-quality database of healthy volunteers, select patient groups, and special populations that we can rapidly recruit for your early clinical program. 

We consider our volunteers to be partners in our clinical trials—their safety, comfort, and feedback is critical to ensuring that we deliver our clinical programs, effectively and reliably.

Explore our early clinical development services

Quotient Sciences deliver comprehensive clinical pharmacology services, including a full suite of healthy volunteer studies and capabilities to recruit for select patient populations.

Clinical services

Clinical study types

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
  • Patient populations (recruited via direct advertising or in collaboration with specialists)

Endpoints

Our team are specialists in Phase I studies, skilled in the delivery of a range of endpoints, including biomarkers and pharmacodynamic measures.

  • Cardiac telemetry
  • Holter monitoring
  • Laboratory biomarkers, including PBMCs
  • CSF sampling
  • Taste assessments
  • Sleep and EEG recording
  • Scales and ratings (e.g. visual analogue scales, diaries etc)
  • Ophthalmology measures
  • Ultrasound

Have a question about an endpoint that we support? Contact us to discuss your specific requirements.

Image
Clinical Pharmacology Services


Our Miami, FL, USA Clinical Pharmacology Unit

  • 144-bed clinical unit
  • FDA approved
  • Database of more than 25,000 active healthy volunteers
  • Ability to recruit select patient populations
  • On-site compounding pharmacy with clean room for sterile products (USP 795/797/800 compliant)
  • All clinical staff are life support trained as a minimum, and licensed EMTs, nurses and physicians are Advanced Life Support (ALS) certified in accordance with local guidelines


Our Nottingham, UK Clinical Pharmacology Unit

  • 85-bed clinical unit
  • MHRA approved, including supplementary Phase 1 accreditation
  • Database of more than 6,500 active healthy volunteers
  • Ability to recruit select patient populations
  • On-site GMP manufacturing
  • All clinical staff are life support trained as a minimum, and all medical staff are Advance Life Support (ALS) certified in accordance with local guidelines

Meet Quotient Sciences Clinical Pharmacology Experts

Dr. Vanessa Zann

VP, Scientific Consulting, Translational Pharmaceutics & Clinical Pharmacology - USA

Dr. Vanessa Zann has over twenty-five years industry experience providing expert biopharmaceutic support to drug discovery, early ...

About Vanessa
Harpreet Smith, MBA, MSN, RN

VP and General Manager, Quotient Sciences - Miami

Harpreet Smith has been with SeaView Research and Quotient Sciences - Miami since 1999, where she has held various leadership role...

About Harpreet
Dr. Alyson Connor

Executive Director, Strategic Partnerships, Clinical Pharmacology

Dr. Alyson Connor has over 25 years of experience in the design and conduct of early-phase clinical programs, with emphasis on the...

About Alyson
Dr. Andrew Parker

Senior Drug Development Consultant

Dr. Andrew Parker has over two decades of experience in the pharmaceutical industry, spanning from preclinical development, throug...

About Andrew

Clinical Pharmacology FAQs

 

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. 

Get in touch
Let’s talk about your drug program’s potential.