The Clinical Research Computing Unit (CRCU) was contracted by Dr. Carl June in 2012 to provide a 21 CFR Part 11 compliant Data Integration System in support of the Engineered T Cells for Cancer Project. The goals of this project was to develop an integrated, personalized medicine data system incorporating a comprehensive set of clinical, manufacturing and biomarker data from an extensive array of data sources.
The CRCU collaborated with the Testosterone Trial Steering Committee for four years in the development of this randomized, placebo-controlled, double-blind study of seven coordinated trials. This preliminary period included a feasibility pilot study and a validation study of several standard instruments using the interactive voice response system. The multi-center set of trials include 12 clinical sites geographically distributed across the United States, a central laboratory, investigational drug service, cognitive function reading center, interactive voice response calling center and prostate biopsy reading center, and pharmacogenomic laboratory.
The Penn Center for AIDS Research (Penn-CFAR) is one of 18 NIH-funded CFARs, and includes HIV and AIDS investigators at the University of Pennsylvania, the Children's Hospital of Philadelphia (CHOP), and the Wistar Institute.
The HOPE Trial is an NIDDK-funded randomized clinical trial to evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease.
The CRCU provides expertise in project management, data coordination and research computing tailored to meet your project requirements.