What is a CRO? How is Quotient Sciences different?
Pharmaceutical CROs provide contract research services, including clinical testing and clinical trials.
At Quotient Sciences, we combine clinical pharmacology and clinical trials capabilities that you would find from a traditional pharmaceutical CRO with our CDMO capabilities for drug product formulation development, clinical, and commercial manufacturing.
We can rapidly recruit for cohorts of healthy volunteers as well as select patient populations to conduct clinical studies from our clinics, located in the UK and US.
Does Quotient Sciences conduct clinical trials?
Dedicated to Phase I trials and early drug development, Quotient Sciences can help accelerate your molecule from first-in-human (FIH) to proof of concept (POC).
Quotient Sciences conduct Phase I clinical trials including:
- First in human clinical studies (FIH)
- Single and multiple ascending dose studies (SAD/MAD studies)
- Drug-drug-interaction studies (DDI studies)
- Bioequivalence studies (BE studies)
- Human ADME studies
- and more
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.
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.
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.