Mission: To facilitate quality clinical trials by providing the research community with comprehensive trial design, data and project management, and analysis services that help move innovative research studies efficiently and rigorously from the initial proposal through execution, analysis and dissemination.
Description: The Department of Biostatistics Clinical Trials and Data Coordination Section offers comprehensive study design, data and project management, and analysis support services to investigators conducting clinical trials using a team approach. We assist with studies supported by federal and foundation grants and industry contracts, including investigator-initiated trials. We offer a team of individuals with experience in the design and conduct of multicenter clinical trials.
Statistical Methods & Analysis
Data Capture and Management
CRIS (Comprehensive Research Information System powered by Velos eResearch) is a secure web-based Clinical Information Management System such that data and protocol information can be entered efficiently and in a standardize format compliant with NIH reporting standards. The comprehensive clinical trials management system supports participant recruitment, study monitoring, trial design, protocol management, and data safety monitoring; case report form construction and dissemination; integration of tissue and clinical information; clinical trial execution and query management; and integration with third party clinical systems. We have designed a web-based software application utilizing the Velos eResearch system. Our Comprehensive Research Information System (CRIS) provides capabilities to:
The system includes in its software programming to maintain compliance with 21 CFR Part 11 as well as various industry and federal standards. The system can support multi-center, cooperative group and investigator-initiated research through advanced technology and security features, all contained in one comprehensive environment. Through utilization of this comprehensive system great improvements in the research productivity, efficiency, collaboration and integrity of data can be achieved. We have designed the Comprehensive Research Information System using the Velos eResearch product as it allows us to design and develop an extensive and custom application while maintaining a data standard shared by other institutions.
Click here for the CRIS Training Request Form
OpenClinica is the world's first commercial open source clinical trial software for Electronic Data Capture (EDC) Clinical Data Management (CDM). In just a few years since its first release, OpenClinica became one of the world's most widely adopted clinical trial software technologies powering research in over 100 countries. During this time, a rich community of innovation has arisen around OpenClinica making it both a robust and uniquely flexible platform used across diverse types of clinical research.
It's easy to use
Application at KUMC: https://Openclinica.kumc.edu
For more training and access information, please contact the CRIS Support Team at firstname.lastname@example.org
For questions regarding the section, please contact
Matthew Mayo, Ph.D., MBA
Professor and Founding Chair, Department of Biostatistics
For analytical services, please submit your project or grant by clicking the Register Now link.