Agenda

Clinical research contracting has historically been managed by staff with high legal acumen, but limited understanding of the approved billing plan, coverage analysis determinations and levels of risk associated with the contracted scope of work. Lack of familiarity with the subject matter and relying on scripted playbook positions is problematic and can lead to unnecessary risk exposure. In this presentation, Brian Sevier, Director, Office of Clinical Research and Jason Cline, Contracting Officer III of the University of Florida will document their experience with the implementation of OnCore and how UF’s clinical research contracting unit leverages all information available to deliver accurate and timely redline reviews of contracts.

While not currently mandated by any regulating body or funder, feasibility reviews are being implemented at many research organizations. With an estimated 20-50% of protocols closing without a single accrual at the site-level, organizations see the importance of determining where to invest resources prior to investing significantly in the entire activation process. To ensure fairness and success, these decisions should be evidence-based, not subjective. Forte has been utilizing machine learning to develop an accrual prediction algorithm. In this session, Wendy Tate, Director, Analytics at Forte will share Forte's progress, including initial collaborations and how this algorithm can fit into the feasibility review process.

Years have passed since you implemented OnCore. The goals you had during implementation are perhaps long in the past. How do you review and assess organizational goals to see if things are on track, or to make continuous improvements? And how do you revisit and realign your use of OnCore to support those goals? In this session, Natalie Hellmer, Senior Project Manager at Forte and Jill McKinley, Staff Augmentation at Forte will help you learn the key steps to driving a process improvement project to reality.

When Duke implemented OnCore, they wanted to create a standardized clinical research experience to manage research from protocol creation to project closeout, create data transparency and align metrics with institutional goals. Emphasizing the minimum footprint, reports were developed and distributed to all Clinical Research Units (CRUs) for monitoring system use and required data capture. In this session, Denise Snyder, Associate Dean for Clinical Research at Duke University will share how Duke reviewed data and distributed information to CRUs. The process made their research leadership and business management have a better understanding of their clinical research portfolio and demonstrated how standardized data capture drives improved research business decisions.

When managing a website for a cancer center or academic medical center, there are a variety of ways to design sites, technologies to use and best practices to consider. This panel discussion, featuring representatives from University of Nebraska Medical Center, Medical College of Wisconsin and Case Comprehensive Cancer Center, will share their experiences with creating websites, accounting for ease of use and accessibility, what information is kept public or private, and more.