Azopharma’s new state of the art clinical pharmacology research unit brings together an impressive blend of experience and services. Members of our clinical pharmacology team have performed a broad spectrum of clinical studies across virtually every therapeutic indication.
Working with local hospitals and academic research units, we can offer customized solutions for our clients’ early phase clinical research needs.
Resources:
- Two custom designed research units
- State of the art clinical monitoring and laboratory facilities
- Experienced clinical leadership team
- Dedicated Medical Director and study coordinators
- University and hospital relationships for unique study collaborations
Clinical Pharmacology Services and Capabilities:
- First-in-human: SD / MAD safety and tolerance studies
- Pharmacodynamic endpoint studies
- Cardiac safety studies
- Drug interaction studies
- Bioavailability / Bioequivalence (SD / MD / Food Effect)
- PK profiling for multiple matrices (Cmax, tmax, AUC determinations)
- POC to Phase II inpatient / outpatient trials
- ADME
- GLP/GCP compliance
- Divisional bioanalytical support
Azopharma’s clinic is strategically located to meet the appropriate demographic profile for recruiting healthy volunteers and specialty patient populations for early phase clinical trials. Our experienced staff of investigator physicians, nurse coordinators, staff scientists and dedicated clinical technologists ensure that studies are conducted in compliance with FDA/ICH guidelines and regulations.
Additionally, our Phase I Express™ process is designed to help clients successfully manage the transition from preclinical to Phase I studies, enabling them to make effective and fast decisions about safety and efficacy of their compounds. Our goal is to streamline the development process, saving our clients time and money.