EDC Functionality, Ease of Data Entry, and Access to Data All Factors in University of Virginia Cancer Center's Selection of the OnCore Clinical Research Management System
MADISON, Wis., Jan. 12, 2011 /PRNewswire/ -- The University of Virginia (UVA) NCI-designated Cancer Center recently made the move from a comparatively sophisticated home-grown clinical trials management system (CTMS) to the OnCore Clinical Research Management System (OnCore-CRM) from Forte Research Systems, Inc.
"We were using a home-grown system that included both Access and Web-based front ends. As a locally-designed system, it fit our workflow well in some ways and offered some modules that were comparable to the best commercial systems," said James H. Harrison, MD, PhD, Director of Biomedical Informatics at the UVA Cancer Center, who helped lead the project to enhance the Cancer Center's informatics infrastructure for clinical research.
While the existing system was good, it had grown incrementally for over 10 years with a number of developers, so aspects of its structure were awkward and difficult to maintain. The system lacked some capabilities of interest to the center such as a standards-based data representation, a unified user interface, and study financials management capabilities.
With the OnCore system, the UVA Cancer Center looks forward to reducing the amount of effort required to maintain their systems and eliminating the need for installed software on users' computers, which had previously caused version management issues. With OnCore, the Cancer Center will now be able to grant access to users via physically remote computers using a standard web browser over the Internet. OnCore also offers more options to be interoperable with other systems throughout the institution as well as with software provided by the NCI's caBIG program.
The choice to upgrade their clinical research informatics was part of a larger objective at the Cancer Center. "We wanted a secure and comprehensive system that is web-based, supports protocol design and tracking, data management, and adverse event reporting. In addition, we wanted a system that was able to track billing information for budget management. Finally, we wanted a system that would be able to generate reports necessary for our NCI Cancer Center Support Grant (CCSG)," said Paula M. Fracasso, MD, PhD, Deputy Director of the UVA Cancer Center.
The University of Virginia Health System has recently implemented EPIC as their electronic medical records (EMR) system. Future plans include communication between OnCore and the EPIC EMR to facilitate information transfer from EPIC's inpatient and outpatient records to OnCore's database for patients who are enrolled on clinical trials.
Work to implement the OnCore system at the UVA Cancer Center has already begun. OnCore will be administered via the Cancer Center's Office of Clinical Research (OCR), which provides comprehensive support for clinical trial research. Members of the Cancer Center will require access to the OnCore system, and they were included in the system selection process. "We have directly engaged these groups during super user and user training," said Harrison. "Our Cancer Center members are looking forward to OnCore and they are excited to have a more comprehensive system that is friendlier to use."
The Cancer Center plans to roll out the new OnCore system in the early part of 2011. The initial implementation will manage all Cancer Center protocols and associated information. This information will include protocol descriptions, protocol documents, research subject demographics, adverse event tracking and reporting, scientific protocol review, and IRB tracking.
By 2012 the Cancer Center hopes to see data exchange between OnCore and the new EPIC EMR system become a reality as the manufacturers of both systems are committed to the Retrieve Protocol for Execution (RPE) data exchange standard being put forth by the Integrating the Healthcare Enterprise (IHE) initiative.
"Our future vision includes transparent communication of data between our clinical EMR, our research data repository, and OnCore. Thus, we expect to manage patients in the clinical setting using the EMR, with information about protocols flowing transparently to both the EMR and the clinical data repository from OnCore, and information about subjects and research visit data flowing transparently from the EMR and the clinical data repository to OnCore without redundant entry," said Fracasso.
Ultimately, the Cancer Center is interested in using the OnCore system for project budgeting, and for billing for all patients on clinical trials.
About the UVA Cancer Center
At the UVA Cancer Center we don't just treat diseases. We treat whole persons and entire families. We do this through a unique disease-specific team approach to care, and an array of services for those who encounter one of life's greatest struggles - a battle against cancer.
As a "National Cancer Institute Designated Cancer Center," the Cancer Center's goal is to deliver cutting edge cancer care, and to create that cutting edge with novel research. Leading programs in clinical and discovery research are supported by over $70 million a year from the National Institutes of Health, the National Cancer Institute, the American Cancer Society, and other agencies. Additionally, the Cancer Center receives philanthropy from friends and grateful patients that supports our mission. Over 150 basic scientists and clinical researchers are involved in cancer research, and there are more than 75 interventional clinical trials actively accruing patients to test new therapies.
The OnCore platform is the flagship product from Forte Research Systems, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations. As the nation's most widely adopted clinical research platform among academic research organizations and cancer centers, OnCore is the result of over a decade of experience working closely with large research organizations, including many world-class NCI-designated cancer centers and institutes funded by the National Institute of Health's Clinical and Translational Science Award (CTSA) program.
OnCore-CRM offers a comprehensive set of modules for managing all aspects of clinical research:
- Protocol & Subject Life Cycle Management
- Subject Safety Management
- Protocol & Subject Calendar Management
- Study Financials Management
- Electronic Data Capture and Data Management
- Paperless Committee Management with ePRMS
- Study Information Portal
- Custom Reporting Technology
In addition to the clinical research management system, two other systems complete the OnCore product portfolio. These are OnCore for Biospecimen Management (OnCore-BSM) and OnCore for Unified Registries Management (OnCore-URM).
For information about the OnCore clinical research informatics platform, contact Forte Research Systems at (608) 826-6000 or visit the company online at www.ForteResearch.com.