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Phase I-II Clinical Trial Services for Biotech and Drug Companies
Currently, we have 4 free standing clinical research units (CRUs) designed to conduct Phase I and Phase II clinical trials determining the effects of a study product in humans. Each CRU has on site laboratories to process pharmacokinetic data to determine how the study product is being absorbed, metabolized and excreted. We conduct these early phase studies in both healthy and patient populations. For many of our clients we also advise and develop the Phase I study design, objective and methodology to enhance safety while maximizing dose optimization with the smallest amount of subjects using population PK study design models when possible.
Most of our Phase II trials can be completed within our CRUs, eliminating or limiting the number of outsourced study centers. We have used several different Phase II study designs to help maximize the product's ability to show sufficient biological activity against the disease, disorder or symptom to warrant further investigation.
Below is a summary of the Phase I and Phase II CRO services offered by Exodon:
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Drug Study Design and Consultation
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Multinational Regulatory Affairs Filing
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Phase I-II Clinical Trials Project Management
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Drug Safety and Pharmacovigilance
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Medical Monitoring
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Data Capture and Management
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Statistical Analysis and Medical Writing
We also have a partnership with another multinational CRO specializing in larger Phase III clinical trials that is also to bridge our clients Phase II and Phase III projects.
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