Integrated, seamless studies.
Our experience spans more than 30 years and 1,300 Phase I studies, including FIH (SAD/ MAD), DDI, TQT, bioavailability, food effect, and 14C ADME studies.
Accelerate your study startup at our clinical units in Miami (U.S.) and Nottingham (U.K.) with industry-leading IRB/EC and CTA approval timelines. In addition, 99 percent of our studies start on time, 98 percent enroll with full cohorts, and 99 percent of our subjects are retained throughout. If you need to access a challenging healthy volunteer population for your study, we rapidly recruit large cohorts of volunteers.
Leverage our experience in all dosage forms, and save time with our strategic approach. For over 30 years, our drug product teams have helped formulate compounds and develop scalable drug products to transition customers from Phase I into Phase II patient trials and beyond.
Our fully integrated programs are led by experienced project managers alongside industry-leading Phase I medical directors who are experts in first-in-human (FIH) and drug-drug interaction (DDI) and thorough QT (TQT) studies.
We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier. How? Our in-house data sciences team rapidly delivers clinical data and insights to move you on to the next milestone as fast as possible.
Experience and Study Types
Over 30 years of expertise to seamlessly deliver your studies with the highest quality service and speed.
Benefit from dedicated study resources
We have the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. If you need a fully integrated solution, including data management, data analysis, statistics, and medical writing, Quotient Sciences is your answer.
- Clinical pharmacology expertise, including FIH (SAD/MAD), DDI, food effect, and ADME experience
- Experienced project managers- guiding your study to successful on-time delivery, within budget and to the highest quality
- On-site pharmacy compounding and integrated real-time adaptive Good Manufacturing Practice (GMP) manufacturing
- Formulation development for all dosage forms, including oral solutions and suspensions, capsules and tablets, sterile preparations (intravenous [IV] and subcutaneous [SC]), inhaled and nasal devices, topical creams and gels
- Early-phase data sciences group providing full-service data management, statistics, and medical writing
- Regulatory support to ensure a seamless FDA or MHRA submission and approval process for clinical trial applications
Clinical Pharmacology Facilities
- Over 650 Phase I studies completed
- Clinical unit with a dedicated 14C ADME ward and laboratory
- On-site pharmaceutical laboratories and GMP manufacturing
- 7,000 active healthy volunteers in our database
- 45 Phase I CTA submissions annually (more than any other UK unit)