Implementation of Enterprise-Wide Clinical Trials Management System Begins

The University of Minnesota is beginning the process of implementing OnCore® from Forte Research Systems as a single enterprise Clinical Trials Management System (CTMS). The solution will be University-hosted and will support a broad range of clinical research, from the Clinical and Translational Science Institute research units, to cardiology, oncology, public health, pediatric medicine, and other University health-research programs. 

The CTMS addresses a campus-wide need for better support of cancer trials, pharmaceutical clinical trials, device studies, case report studies, multi-center studies, and large-scale epidemiological studies.

"The CTMS is critical to our continued success as a leader in health research."

Brian Herman, Former Vice President for Research

It is designed to enhance the efficiency and quality of health research at the University of Minnesota by:

  • Reducing the cost of redundant software infrastructures
  • Consistently capturing and tracking protocol, study, administrative, and financial data needed for management of trials
  • Increasing the capability to provide meaningful reports and data regarding the financial status of a study to Principal Investigators
  • Reducing costs to manage clinical research within individual units
  • Reducing multiple isolated, informal environments for managing and tracking study data
  • Improving regulatory compliance

"The CTMS is critical to our continued success as a leader in health research," explains Brian Herman, vice president for research. "Using a single, centrally supported system to manage our clinical research enterprise allows us to achieve new efficiencies, eliminate redundant processes and, ultimately, translate our discoveries into better health, faster. It's a great example of President Kaler's operational excellence initiative in action." 

The enterprise CTMS is supported by the CTSI, which is part of the national NIH-funded Clinical and Translational Science Award program.

Biomedical Health Informatics Director Connie Delaney notes, "The CTMS has been a consistent and core need for our research enterprise and in partnership with CTSI, the Office of Biomedical Health Informatics has formed an expert, experienced inter-professional team to create the UMN enterprise CTMS to meet operational excellence objectives, ensure successful implementation and ongoing sustainability."

The system will be rolled out in phases, with the Medical School Division of Cardiology, the Masonic Cancer Center, and Pediatric Oncology among the first users.

CTSI director Bruce Blazar explained, "Through the Biomedical Health Informatics team, we've been listening closely to faculty and staff about what systems and tools are needed on campus. We've heard overwhelmingly that we need to reduce duplication of effort, provide user-friendly financial and administrative reports, offer better support for meeting regulatory requirements, and reduce overall costs associated with managing clinical research. The CTMS is key to meeting those needs, not just within the Academic Health Center, but for all those conducting and supporting health research across the University."

The implementation team is collecting and posting answers to Frequently Asked Questions on the Biomedical Health Informatics website, and the Clinical and Translational Science Institute's monthly e-newsletter will feature regular updates and announcements about the project.