Office of Clinical Research Making Strides
Now that the new OnCore clinical trial management system is up and running, the UR CTSI’s Office of Clinical Research (OCR) has begun to build out several service lines to help researchers with various aspects of their clinical trials. From educational opportunities to study feasibility and financial services, the OCR is taking the University of Rochester Medical Center’s clinical research enterprise to the next level.
Last year, the OCR supported unlimited institutional attendance of Advarra’s Onsemble conference for the first time. The conference, which is held annually in the spring and fall, covers a wide range of topics related to conducting clinical trials, including leveraging technologies to improve the conduct of clinical research. In the fall of last year, the OCR supported attendance of 38 University of Rochester staff, faculty or trainees. In the spring that number nearly doubled to 60 attendees from the university.
Over the past year, the OCR launched two service lines offering research finance and study feasibility services.
The Research Finance service line provides uniform and central services for both pre- and post-award clinical trial financials. At a rate of $50 per hour – which can be built into the study budget, clinical researchers can select from an extensive list of financial services: coverage analysis, study cost and timeline analysis, budget negotiation and creation, sponsor invoicing, revenue reconciliation, monthly research billing review and more.
Currently, the OCR provides financial services for more than half of URMC departments running clinical trials that have billable services – and the return on investment is substantial. Across 12 studies, the OCR Research Finance service line has negotiated on average nearly $40,000 more into each research study budget. for protocol and subject-related costs. That amounts to a cumulative return on investment of nearly $480,000.
Laurie Passalacqua, M.S., the director of Finance and Administration for Pediatric Adolescent Medicine, Pediatric Endocrinology and Pediatric Infectious Diseases, says the benefits of using OCR’s Research Finance service line have been huge. “We are actually recouping funds for what we budgeted and negotiated. By using OCR, we know we're getting our startup costs paid for. We know we're getting reimbursed for our storage costs. We know that we're billing out for extraneous procedures that may have been done in the past,” she said.
The OCR is also helping clinical research teams assess the feasibility of their proposed clinical studies and develop meaningful study metrics through its Study Feasibility service line. The OCR feasibility assessment will examine the feasibility of a study in terms of resources (staff, investigators, space, equipment and patient population) as well as financial feasibility, and the timeline as it relates to start up and enrollment. Research teams can also get help with cohort discovery and with developing and submitting confidentiality and non-disclosure agreements.
The Study Feasibility line also connects researchers with multisite clinical trial opportunities from TriNetX Connect and the OCR’s relationships with industry sponsors and clinical research organizations. In the 2021-2022 fiscal year, the OCR received 215 such opportunities.
While the OnCore rollout is complete, the OCR team continues to improve its training and services for OnCore users. From a recent survey of 329 active OnCore users, 78% of respondents preferred remote demonstration and hands-on training. As a result, the office will begin supplementing current self-guided training with additional live weekly trainings and workflow labs as well as OnCore consultations and one-on-one support.
The training team has also aligned OnCore training with relevant workflows in order to allow study teams to realize the full benefit of OnCore’s integrations with Epic and Workday. Utilization of OnCore enhances regulatory compliance while streamlining the management of clinical trials.
Interested in using an OCR service? Fill out a service request form.
Susanne Pritchard Pallo |