Achieve your FIH and POC milestones.
The transition from preclinical to clinical testing is a pivotal moment in drug development. It’s also one of the most challenging.
Unknown risks, complex protocols, and regulatory hurdles can delay progress and put your investment at risk. Partnering with an experienced first-in-human specialist such as Quotient Sciences is the key to navigating this critical phase with confidence.
Through our work with small molecules and biologics, we provide the expertise, infrastructure, and agility needed to move your novel therapy forward, faster.
Achieve your molecule’s full potential with our extensive experience in clinical testing
Tailored strategies for first-in-human to proof-of-concept testing, backed by trusted data and the insight you need to navigate the increasing complexity of drug development.
We can help you with solutions that:
- Seamlessly integrate early clinical programs
This includes SAD/MAD in healthy volunteers and patient cohorts for initial POC, looking at a range of biomarkers. Integrated bioanalysis, PK and data sciences enables rapid turnaround of data and reporting.
- Provide access to special populations and patients for POC assessments
In the US and UK, access a broad range of patients across therapeutic areas such as inflammation, metabolic diseases, and CNS, along with capabilities for recruitment of special populations such as healthy elderly and post-menopausal women.
- Keep you in control of your program
Programs are led by experienced project management and medical staff, with scientific and regulatory support. We aim to keep your clinical study on-course, while always keeping volunteer and patient safety in mind.
Your path from first in human to proof of concept study
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
Therapeutic Areas
- Cardiovascular
- Dermatology
- Endocrinology & Metabolic
- Gastrotenterology
- Haematology & Immunology
- Hepatology
- Infectious disease
- Muscoskeletal
- Nephrology & Urology
- Neurology & CNS
- Opthalmology
- Psychiatry
- Pulmonary & Respiratory
- Reproductive & Women's Health
- Rheumatology
- Rare & orphan diseases
- and more
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)
Purpose-built Phase I units, dedicated to the success and safety of your study.
Ensuring the safety of trial participants while mitigating risk is 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.
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.