The Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials provides complete biostatistical and operational support for clinical trials in the area of autoimmune diseases. Studies currently being supported include multiple autoimmune disease clinical protocols sponsored by the Autoimmunity Centers of Excellence, as well as autologous stem cell transplantation for autoimmune disease. Support for these and other studies in autoimmunity will include: 1) statistical leadership for the design and analysis of clinical trials, including periodic safety and administrative reports, Data Safety Monitoring Board reports and final analyses;2) clinical site monitoring and training;3) data collection, management and quality assurance programs;4) regulatory support for IND and associated regulatory submissions, including serious adverse event data collection, evaluation and report preparation;5) distribution and quality control of study products;and 6) support for technical and administrative functions of the clinical trial consortiums.

Agency
National Institute of Health (NIH)
Type
Research and Development Contracts (N01)
Project #
272200900057C-3-0-1
Application #
8750923
Study Section
Project Start
2009-09-30
Project End
2014-09-29
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$1,229,326
Indirect Cost
Name
Rho Federal Systems Division, Inc.
Department
Type
DUNS #
362726007
City
Chapel Hill
State
NC
Country
United States
Zip Code
27517