Clinical Pharmacology
Clinical Pharmacology Experts Focus on the Science of Your Compound
In Phase I clinical trials, you want to determine product viability and monitor patient safety to inform Phase III studies. You need a partner who will help you maximize your product benefits and minimize the side effects. With a deep bench of scientific experts, we provide the full spectrum of pharmacokinetic / pharmacodynamic (PK/PD) services – from coordinating first-in-human studies to negotiating pharmacokinetics labeling.
Our clinical physiology team of Phase I/IIa scientists is devoted to developing specialist techniques and conducting complex research. These scientists carry out specialist procedures and investigations on healthy volunteers and patients, ensuring quality data by critically evaluating its accuracy. They provide expert opinions on protocol design and scientific integrity as well as participate in protocol and clinical study report development. The team conducts self-funded research projects to develop and validate translational biomarkers and methodologies that can be applied to healthy volunteers and patients providing important information on safety as well as drug efficacy.
Collaborate with Leading Pharmacology Experts
Quintiles scientists apply their extensive experience and expertise to design and conduct your early clinical trials. Together we work with you to:
- Develop a clinical pharmacology strategy for each product
- Incorporate the latest thinking from key opinion leaders via the Quintiles Academic Collaboration Network and from the Quintiles Phase I Global Safety Committee
- Advise and review pre-clinical strategy for successful regulatory submissions
- Prepare Phase I components of IND, CTA and NDA submissions
- Design product-specific studies to inform decision-making for further development
- Use single and adaptive trial design to enable a safe, focused investigation to achieve both study and product objectives
- Advise on starting doses, dose stagger, dose escalation and titration regimens as appropriate
- Employ and develop novel methods to accelerate Phase I/IIa proof of concept
- Provide quality-controlled safety, PK/PD data and review to support dose escalation
- Perform PK/PD modeling to guide dosing-regimen design for current and later phase studies
- Establish definitive QT and perform TQT analysis with the industry’s largest staff of cardiologists
- Study human metabolic fate/mass balance
- Support end-of-Phase II, pre-NDA and advisory panel meetings
