Statistical and Data Management Center

Statistical and Data Analysis Center  (SDAC)

Senior-level biostatisticians at the Statistical and Data Analysis Center (SDAC) provide complete statistical support, from study design through data analysis and publication.

These biostatisticians:

  • Are among the leading experts in clinical trial design and analysis and are associated with the Harvard School of Public Health
  • Are core members of each protocol team, providing statistical input from study inception through publication
  • Design, review, and revise the statistical section of protocols, as necessary
  • Prepare and present interim analyses to an independent Data and Safety Monitoring Board
  • Provide special toxicity reports, as required
  • Conduct the final analysis described in the protocol, as well as secondary analyses suggested by the data

Michael Hughes, Ph.D. is the Director of the Statistical and Data Analysis Center.

Data Management Center (DMC)

Data management is provided by Frontier Science Technology and Research Foundation (FSTRF) of Amherst, N.Y. Experienced clinical data managers employ advanced system technologies to collect data from remote sites to a central mainframe computer. Each protocol team is assigned a clinical data manager who:

  • Designs and develops the protocol-specific case report forms to optimize data collection (with input from the protocol team and selected clinical sites)
  • Participates in protocol- and site-specific training
  • Monitors the timeliness and quality of the data and contacts sites for corrections and delinquencies
  • Provides advice and instruction to the clinicians in the accurate completion of study forms
  • Runs standard reports at specified intervals for purposes such as preparation of annual FDA progress reports
  • Acts as liaison between the team and the clinical sites concerning all aspects of data required during conduct of the study

Marlene A. Cooper, M.S. is the Director of the Data Management Center.