How do I achieve rapid study start up and fast participant recruitment?
Quotient is your answer.
Clinical Pharmacology
Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment through our locations in Jacksonville, Miami (U.S.) and Nottingham (U.K.).
Our full-service science and medical teams will work with you to design a tailored program, based on the needs of your compound, to meet the rigorous requirements of major regulatory agencies. Your clinical pharmacology program can include exploration of drug metabolism pathways, drug-drug interactions and an assessment of cardiac safety. These programs will be delivered under the leadership of a single project manager to ensure that you reach your targets as efficiently as possible.
Dedicated to your study
- Purpose-built Phase I units in U.S. and U.K.
- More than 400 beds globally
- Experienced team of more than 25 physicians and principal investigators
- Database of >25,000 healthy volunteers
- >1,200 Phase I studies completed
- MHRA/FDA inspected facilities
- Industry leading U.S. IRB and U.K. CTA approval timelines
Quotient has the experience and expertise to seamlessly deliver your studies with the highest quality service and speed to clinical data. If you need a complete service including data management, data analysis, statistics and medical writing, Quotient is your answer.
Your program will benefit from dedicated study resources
- Clinical pharmacology expertise including first-in-human (SAD/MAD), DDI, food effect and ADME experience
- Project management with experienced project managers guiding your study to successful delivery on time, to budget, and to the highest quality
- Onsite pharmacy and ISO Class 7 clean room and Class 5 laminar flow for aseptic preparation
- Integrated real time adaptive GMP manufacturing
- All dosage forms including oral solutions and suspensions, capsules and tablets, sterile preparations (IV and SC), inhaled and nasal devices, topical creams and gels
- Rapid subject recruitment based on a database of a broad population and more than 25,000 healthy volunteers
- Bioanalytical support with rapid turnaround
- Full-service data management, statistics and medical writing to support protocol development, data analysis and reporting
- Regulatory support to ensure a seamless FDA/MHRA submission and approval process for clinical trial applications
Experience and study types
Access Quotient's expertise with a variety of study types and subject populations.
- First-in-human (SAD/MAD)
- Drug-drug interaction (DDI)
- Food effect
- Thorough QT (TQT)/Cardiac safety
- Bioavailability, dose proportionality and absolute bioavailability
- Bioequivalence
- Biosimilars
- 14C ADME/Mass Balance
- Proof-of-Concept
- Pharmacodynamics/biomarkers
- Japanese bridging
Special populations
- Healthy participants
- Ages 65 and older
- Post-menopausal
- Male and female infertility
- Hypertensive
- Type II diabetics
- Asthma and allergic rhinitis
- Obesity
- Healthy smokers
- Gastrointestinal diseases
- Japanese
Which clinical pharmacology support service could help me?
If you want your study to start fast with recruitment on time and in full, Quotient is your answer.
Related Links
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