How do I find an integrated solution for first-in-human and clinical pharmacology programs?
Quotient is your answer.
Proven track record spanning 30 years
>1,300 Phase I studies completed
Experts in first-in-human (FIH) and drug-drug-interaction (DDI) studies
Industry leadingPhase I medical directors
Ability to rapidly recruit large cohorts of volunteers
Fully integrated programs led by experienced project managers
Dedicated to your Phase I study
- Purpose-built Phase I units in U.S. and U.K.
- 245 beds globally
- Experienced team of 16 physicians and principal investigators
- Database of >25,000 healthy volunteers
- MHRA- and FDA-inspected facilities
- Industry-leading U.S. IRB and U.K. CTA approval timelines
- 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 GMP manufacturing
- Formulation development for all dosage forms including oral solutions and suspensions, capsules and tablets, sterile preparations (IV and 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
Experience and study types
- FIH (SAD/MAD)
- Food effect
- Thorough QT (TQT) / cardiac safety
- Bioavailability, dose proportionality and absolute bioavailability
- 14C ADME / mass balance
- Pharmacodynamics / biomarkers
- Japanese bridging
- Healthy participants
- Ages 65 and older
- Male and female infertility
- Type II diabetics
- Asthma and allergic rhinitis
- Healthy smokers
- Gastrointestinal diseases
How can I simplify the delivery of my human ADME study? Quotient is your answer.Learn more
How do I ensure high-quality regulatory submissions? Quotient is your answer.Learn more
How do I access expert data services for my clinical pharmacology studies? Quotient is your answer.Learn more
Modeling and Simulation
How do I enhance my clinical development program using modeling and simulation? Quotient is your answer.Learn more
When you are looking for a partner who is dedicated to Phase I trials and early development, rely on Quotient Sciences. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier.
Development and optimization of MR formulations in the absence of predictive laboratory or preclinical models
The integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic (PK) study in healthy volunteers was successfully applied to develop an HPMC matrix tablet that achieved the desired PK characteristics for SLx-2101.The key formulation variables influencing performance were the range of dose and release rate, hence a two-dimensional (2D) design space was mapped by manufacturing and characterizing four “regulatory batches” bracketing the corners of the compositional ranges.
Application Of Non Standard Approaches To Investigations Of Human Mass Balance And Metabolite Characterisation
Conventional human metabolism studies are well understood study designs which help drug companies generate data to support drug development and registration. Variations from conventional study designs can be required as a result of the specific characteristics of individual drugs or the need for particular data to support drug registration. This poster describes scenarios where alternative study designs and approaches have been required.
First-in-Human to Proof-of-Concept
Our Translational Pharmaceutics approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.