Practice Areas

The right clinical and behavioral research program can make or break a new drug application, an Rx to OTC switch, or risk management program or REMS.

PinneyAssociates 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 Rx to OTC switches, new drug applications, risk management programs and REMS, and marketing claims.  

Our clinical and behavioral research experts design and analyze a broad range of research programs.  Our team:

• Designs comprehensive clinical development programs from pilot studies to Phase III studies for new indications (including safety and efficacy trials, label comprehension studies, and actual use trials) and Phase IV studies for novel marketing claims or post-marketing surveillance research
• Plans, designs, and analyzes behavioral research, including focus groups, one-on-one interviews, quantitative surveys and market research (including mail, telephone, and online surveys), laboratory studies, and clinical trials
• Develops study protocols, case report forms, questionnaires, and final study reports
• Develops behavioral support programs and educational materials to accompany medications, to enhance efficacy, and/or to promote appropriate use
• Writes reviews of the scientific literature and other detailed reports for regulatory submissions and FDA Advisory Committee meetings
• Produces peer-reviewed publications and presentations for scientific meetings and conferences.