| A comprehensive clinical plan that meets regulatory requirements is the key to successful drug development. Our team will work closely with you to optimize your clinical plan by exploring alternate strategies that may shorten the total drug development time and/or reduce its cost. In several of the studies we’ve seen through to FDA approval, our client’s ultimate success has been a result of enhancing or adjusting the clinical plan. Versante provides value at each stage of the drug development process and our efforts to improve the clinical plan have proven crucial to ultimate regulatory approval. |
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| Versante has expertise in all phases of drug development: |
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Phase I/II Safety and Dose Finding Studies |
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Phase II Proof of Concept Studies |
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Randomized Controlled Phase III Trials |
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Phase IIIb and IV Trials |
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Pharmacokinetic and Pharmacodynamic studies |
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Bio-equivalence and Therapeutic Equivalence Trials |
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