Clinical Pharmacology Services

Our experience spans more than 30 years and more than 1,300 Phase I studies delivered at our clinical units in Miami (US) and Nottingham (UK). Our programs are led by experienced project managers alongside skilled scientists and industry-leading Phase   I physicians numbering over 15 across both sites. Our team has expertise in the full suite of healthy volunteer studies, including first-in-human (FIH), drug-drug-interaction (DDI), food effect (FE), bioequivalence (BE), thorough QT (TQT) and ADME. You can feel confident that your molecule is in safe hands.

Our project management team has over 200 years of collective experience. Each manager leads a matrix team that integrates functions, sites, and stages of development. And they are all committed to forming strong partnerships and true collaboration—by putting you at the heart of how we deliver every project. It’s why over 90% of our customers say they plan to work with us again in the future.

Accelerate your study start-up at our clinical units in Miami (US) and Nottingham (UK) with industry-leading IRB and REC/MHRA approval timelines.  Our highly experienced regulatory specialists and scientists prepare, submit, and manage your submission.  In-depth understanding of the regulatory environment, and strong collaborative relationships with key stakeholders result in a high-quality submissions and fast approvals. 

Our robust databases comprise more than 31,500 active healthy volunteers, and our dedicated recruitment and screening teams are focused on meeting the needs of your study.      
We have a volunteer-centric approach, regularly engaging our volunteers to help us maintain our outstanding metrics for delivery. We consider our volunteers to be partners in our clinical trials—their safety, comfort and feedback is important to us. And our statistics prove our success: 99% of our studies start on time; 98% enroll with full cohorts; and 99% of our subjects are retained throughout.
 

We manage every aspect of end-to-end clinical pharmacology services across healthy volunteer study programs—including data management, analysis and interpretation, all the way through generation of the clinical study report.
Our expert scientific and medical teams advise on your optimal design by leveraging their extensive experience in complex protocols, including multi-part, flexible, and umbrella designs. This approach ensures seamless execution and delivery of high-quality results tailored to your needs, all under a single contract and led by a single project manager.
 

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.

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.