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.
Clinical pharmacology involves the study of drugs in either healthy volunteers or patients. At Quotient Sciences, our clinical pharmacology services cover all aspects of Phase I clinical trials, including trial design, project management, and medical writing (such as synopses and clinical protocols). We can support study types including first in human (FIH), including SAD/MAD, bioavailability/pharmacokinetics, bioequivalence (BE), biosimilars, pharmacodynamic/biomarker, food effect (FE), drug-drug interaction (DDI), cardiac monitoring/Thorough QT (TQT), human ADME, microdose/microtracer, and ethnobridging.
Clinical pharmacology involves the study of drugs in either healthy volunteers or patients. At Quotient Sciences, our clinical pharmacology services cover all aspects of Phase I clinical trials, including trial design, project management, and medical writing (such as synopses and clinical protocols). We also handle regulatory submissions, project management, subject recruitment and screening for healthy volunteer studies, and offer pharmacy compounding services at our Miami, FL CRO facility. Our expertise extends to clinical conduct, data management, pharmacokinetics, and statistical analysis, including clinical and statistical programming. 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.