How Can Research Teams Save Time and Money? Ask the Office of Clinical Research
- The Office of Clinical Research helps research teams evaluate studies, manage finances, handle administration, and maintain regulatory and financial compliance.
“We help research teams save time and money so they can focus on the important clinical work of their projects,” said Ashlee Lang, MPH, director of the OCR. “We have a number of tools and services that helps make that possible, including feasibility evaluation, financial services, and the Advarra suite of clinical study management applications which includes OnCore, eReg, and the Participant Payments system.”
Feasibility Services
Research teams can have a proposed study stress-tested through Feasibility Services, which evaluates projects to determine if URMC has the infrastructure, patient count, and resources necessary to make their trial a success.“Feasibility Services empowers departments to make informed decisions about which clinical trials to activate,” Lang said. “These consultations save departments and the larger institution money and time by identifying strong studies and helping teams revaluate and improve projects that need additional planning and support.”
The consultation includes a customized risk assessment for each clinical trial evaluated and provides a financial break-even analysis supported by the Informatics and Analytics branch for medium- and high-risk trials.
“Research teams can learn exactly how many study subjects they need to enroll to make their trial financially viable,” Lang said.
Since its launch, the service has proven quite popular. Feasibility Services requests have increased 191% since 2024.
Research Finance
Once a study is determined to be viable and approved, managing its finances from launch to completion is another significant challenge.The OCR Finance Team can be utilized for budgeting for all possible study-related items, seeking Medicare Coverage Analysis, negotiating the budget, and managing invoices and reconciliation for the project.
“We can be contracted for budgeting, build calendars in OnCore, and we negotiate on your behalf with the study sponsor,” Lang said. “We also work with Research Compliance to move the study through the appropriate signoffs to achieve an 'Open for Accrual' status."
Post-award services include invoicing the sponsor, tracking payments and invoices through OnCore, conducting billing review for each involved patient, and more.
“We focus on ensuring consistency and compliance,” Lang said. “There’s a lot to consider and track, but the OCR team can be your advocate and collaborator when it comes to managing the complex finances of a study.”
Learn more about OCR's Research Finance services.
Study Subject Support
Paid study subjects need to be compensated accurately and on-time. By using the Participant Payments application, the OCR saves study teams time and effort when paying subjects while maintaining compliance with federal tax regulations. The system provides automated stipend distribution, record-keeping, expenditure tracking, and more.“You can pay study subjects immediately and help them feel appreciated and taken care of,” Lang said.
Empowering the Research Team
The OCR provides additional services, including the Advarra eRegulatory Management System, to compliantly store and share protocol documents, staff credentials, and regulatory tracking documents in a 21 CFR Part 11 Compliant application.The largest application OCR supports is OnCore, the University’s clinical trial management system that centralizes study administration, patient enrollment, and tracking of study finances.
“We will give your team everything it needs to plan and execute a successful study,” Lang said. “We help make clinical research happen faster, on-time, on-budget, and with happy study subjects.”
You can learn more about the OCR through its webpage, or contact clinical_research@urmc.rochester.edu to discover how the team can assist you.
Jonathan Raab | 5/6/2025
