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Program Management
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Phase IIa proof-of-concept services
Once you have completed first-in-human studies, proof-of-concept studies may begin. These Phase IIa studies are conducted under controlled conditions in a small population of target patients to demonstrate efficacy of a new drug.
Utilizing our Program Management expertise, your program smoothly transitions into Phase IIa. You will have access to our clinical and pharmacometric staff for study design and conduct, to our bioanalytical staff for correlating PK/PD parameters and to the capabilities of Covance Central Laboratories for safety monitoring.
Phase IIa services
- Feasibility and risk assessment
- Site selection and prequalification
- Project management
- Monitoring
- Site management
- Study design
- Contract and financial management
- Recruitment support
- Staff training
- Protocol and CRF development.
Therapeutic experience
- Vaccines
- Pulmonary
- Cardiovascular
- Renal and hepatic
- Endocrine and metabolic
- Neurology (CNS)
- Immunology and anti-infectives
- Analgesics, anesthetics and anti-inflammatory
- Gastrointestinal
- Oncology.
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