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Program Management
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First-in-human services
A critical milestone in drug development is initiation of a first-in-human clinical trial. The nonclinical drug disposition and safety assessment studies completed prior to Phase I provide data to enable evaluation of the safety of single and multiple doses in human volunteers.
Guided by your Program Manager, your project seamlessly progresses to first-in-human studies. You have access to two state-of-the-art Clinical Research Units in Madison, WI and Leeds, UK. Each unit is staffed with physicians, clinical pharmacologists, project managers, clinical research associates and data managers to help you develop and execute your Phase I protocols.
First-in-human services
- Preclinical summary
- Single/multiple rising dose design
- Pharmacodynamics
- Pharmacokinetics
- Pharmacometrics
- Clinical monitoring
- Phase IIa clinical design.
Facilities
- 72 beds/facility
- Complete telemetry capabilities
- Electronic data capture system
- Dietary services
- 24/7 medical coverage
- Radiopharmacy services
- Independent Quality Assurance Units
- Healthy and special population volunteer database
- Access to consultants including physicians, scientists and QPs (qualified persons)
- Extensive pharmacodynamic capabilities
- Dedicated Phase I IEC/IRB
- Security controlled.
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