A comprehensive and insightful 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 various strategies in order to shorten the total drug development time and/or reduce its cost. In several of the studies we have seen through to FDA approval, our clients’ ultimate success has been a result of enhancing or adjusting the clinical plan. Versante provides value at each stage of the drug development process. Our efforts to improve the clinical plan have proven crucial to ultimate regulatory approval.
Versante has expertise in all phases of drug development:
Phase I/II Safety and Dose Finding Studies
Phase II Proof of Concept Studies
Randomized Controlled Phase III Trials
Phase IIIb and IV Trials
Pharmacokinetic and Pharmacodynamic Studies
Bio-equivalence and Therapeutic Equivalence Trials
   
 
 
Statistical Analysis and Reporting
Biometrics
Clinical Plan Development
Protocol Development and Study Design
Therapeutic Expertise Consultation
Data Management
Electronic Data Capture (EDC)
CDISC Conversion
 
 
 
 
 
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