Data Management and Statistical Analysis

The Data Management and Analysis Team provides critical support for the planning, management, analysis, and interpretation of data from client-sponsored market research and clinical trials, and from public use data sets. Data analyses allow for data submissions to the FDA in support of regulatory and marketing efforts, and augment internal responses to FDA and thought leader concerns.

The Data Management and Analysis Team:

Develops statistical analyses of market research data, clinical studies, behavioral support programs, and public use datasets for internal and external use, including peer-reviewed articles, reports for submission to FDA and assessment of risk management programs
Develops data analytic plans to assess the protocol and objectives of clinical trials and market research (including mail, telephone, and online surveys), and behavioral research
Assist in the development of study protocols, case report forms, and questionnaires necessary to conduct clinical research, and in preparations for regulatory submissions, regulatory meetings, and FDA Advisory Committee meetings
Establishes and directs quality assurance and quality control procedures
Develops sample size estimates for clinical research projects, in coordination with our Clinical and Behavioral Research Team
Develops and implements database management systems to ensure the validity and consistency of data
Produces peer-reviewed publications and presentations for scientific meetings and conferences