The Statistical Analysis of Biomedical and Educational Research Group (SABER) unit of the Department of Biostatistics provides expertise in the design, conduct, and analysis of multi-center clinical trials and multi-disciplinary research.
A message from Director Cathie Spino, ScD
"What truly sets SABER apart is our willingness to work in partnership with investigators to tackle new challenges in clinical research --- Whether it be a statistical methodological issue such as handling non-compliance in a randomized clinical trial of a behavioral intervention, or an operational issue such as development of a bar-coded specimen tracking process and database for an observational cohort study, SABER applies its resources to deliver time-effective design and quality-based output that meet investigational needs."
Founded as the Center for Clinical Investigation & Therapeutics (CCIT) by biostatistics professor Dr. Morton Brown in 1999, the center has also been known as the Center for the Advancement of Clinical Research (CACR) and Biometrics and Outcomes Research Core (BORC) prior to the 2011 launch of SABER.
We have served as the data coordinating center (DCC) for NIH network-based, individual-investigator, and pharmaceutical company-sponsored studies. We have the capacity to simultaneously support multiple clinical studies at various stages of development. These collaborations have led to numerous publications in peer-reviewed journals and presentations or posters at scientific meetings.
Statistical expertise and experience differentiates SABER from other groups that support clinical studies. SABER is housed within the department of biostatistics at the University of Michigan School of Public Health, rated the top biostatistics program in the country by the National Academies. We bring biostatistical design and analysis expertise to a wide spectrum of health-related issues. Our faculty, students, and staff work in important and diverse areas of current biostatistical research including image analysis, survival and event history analysis, statistical genetics and bioinformatics, clinical trials, Bayesian methods, statistical computing, longitudinal data analysis, methods for missing data, and survey research.
SABER employs dedicated personnel and tools that provide collaborative expertise in design, conduct, and analysis, administrative coordination and communication, study planning and management, data management, quality control and assurance, and human subjects' protection and regulatory affairs for single and multicenter clinical studies. SABER has a robust internal training and quality control environment, with standard operating procedures, work instructions and checklists for common activities. Study start-up and study close-out debriefing sessions present training opportunities for new staff and faculty.
Data is at the core of our center's business ... and to that end, we provide a robust computing environment that includes secure, redundant servers for database and web applications, an Oracle back-end database, and a web interface for site data entry and management. We collaborate with MICHR (another University of Michigan Institute dedicated to clinical research) on the deployment of a 21 CFR Part 11 compliant database system, OpenClinica, for many of our current studies; however, that product is being sunsetted and we are transitioning to our new 21 CFR Part 11 compliant platform, REDCap Cloud.