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Rutgers-Cleveland Clinic Consortium of AFIRM Selects OnCore(r) to Support its Collaborative Clinical Research on Regenerative Therapies

November 4th, 2009

MADISON, Wis. (November 4, 2009) — When evaluating what was needed to support a widely distributed consortium comprised of 15 organizations across the country who are conducting cutting-edge collaborative clinical research, the Rutgers-Cleveland Clinic Consortium (RCCC) selected the OnCore Clinical Research Management system (OnCore-CRM) to administer their studies and coordinate the group’s efforts.

The Rutgers-Cleveland Clinic Consortium is part of the Armed Forces Institute of Regenerative Medicine (AFIRM), a multi-institutional, interdisciplinary network working to develop advanced treatment options for the nation’s severely wounded servicemen and women.

Administrative oversight for all of the RCCC trials will be provided by the Clinical Trials Core which is housed at Case Western Reserve University. It is this group, headed by director Stanton Gerson, MD, that will implement and maintain the OnCore system as well as provide consortium-wide training on its use.

“Our primary need was to assist the Clinical Trials Core (a non participant in any of the trials) to manage the data and regulatory reporting from remote and multicenter sites. Secondarily, OnCore will help us track the regulatory approval and other review processes from all of the sites,” said Jane Reese, Operations Director at University Hospitals Case Medical Center.

Through OnCore’s web-based interface, each of the participating organizations will be entering data throughout the lifecycle of their clinical trials. They’ll enter information related to their local regulatory and administrative processes prior to opening the trials at their institution; they’ll enter clinical and safety data throughout the conduct of the trials; and they’ll track follow-up milestones after the trials are completed. With this central database, the Clinical Trials Core will be able to monitor patient safety and track study progress across all the participating organizations.

In addition to its web-based platform, OnCore was desirable because of the control it provides.

“Two of the things we like best about OnCore are that it is configurable by us and the data is housed by us. This is in contrast to other affordable systems in which configuration and modifications are performed by the vendor,” said Reese.

Led by principal investigator, Joachim Kohn, PhD of Rutgers, the State University of New Jersey, and co-principal investigator George F. Muschler, MD of Cleveland Clinic, the RCCC team is built around an outstanding group of experts, working at advanced performance sites with approximately 160 personnel including about 40 faculty members and more than 40 post-doctoral associates. Participating institutions include Carnegie Mellon, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, Thayer School of Engineering at Dartmouth, Massachusetts General Hospital, Massachusetts Institute of Technology, Mayo Clinic, Northwestern University, Stony Brook University, University of Cincinnati, University of Medicine & Dentistry of New Jersey, University of Virginia, and Vanderbilt University. For more information on the AFIRM RCCC, visit the website at www.afirmrccc.org.

The OnCore platform is the product of PercipEnz Technologies, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations. The nation’s most widely adopted clinical research platform among academic research organizations and cancer centers, the OnCore platform is the result of nearly 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 ePRMSM
  • Study Information Portal
  • Custom Reporting Technology

In addition to the clinical research management system, two other systems complete the OnCore family of products. These are OnCore for Biospecimen Management (OnCore-BSM) and OnCore for Unified Registries Management (OnCore-URM).

For information about the OnCore research informatics platform, contact PercipEnz Technologies at (608) 826-6000 or visit the company online at www.PercipEnz.com.

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