The Clinical and Behavioral Research Team supports pharmaceutical and consumer healthcare clients at all stages of their clinical development programs, both pre- and post-FDA approval.  This comprehensive approach facilitates the development of sound, science-based research to support prescription to over-the-counter (OTC) switches, new drug applications, and marketing claims.

The Clinical and Behavioral Research Team:

• Designs comprehensive clinical development programs based on existing scientific knowledge, previous clinical studies, commercial strategy, and project objectives
  
  
• Designs clinical studies, from pilot studies to Phase III studies for new indications (including safety and efficacy trials, label comprehension studies, and actual use trials [AUTs]) and Phase IV studies for novel marketing claims or post-marketing surveillance research
  
  
• Develops study protocols, case report forms, questionnaires, and statistical analysis plans necessary to conduct clinical research
  
  
• Plans, designs, and analyzes survey and market research (including mail, telephone, and online surveys) in coordination with our Data Management and Analysis Team
  
  
• Develops behavioral support programs to accompany medications, to enhance efficacy, and/or to promote appropriate use, as part of a risk management plan
  
  
• Designs and analyzes clinical research to evaluate the efficacy of behavioral support programs
  
  
• Assists in preparations for regulatory submissions, regulatory meetings, and FDA Advisory Committee meetings
  
  
• Produces reviews of the scientific literature and other detailed reports based on scientific and public health assessments
  
  
• Produces peer-reviewed publications and presentations for scientific meetings and conferences