Agenda

In this session, Kristen Matta and Tim Van Dijk, analysts from the University of Michigan’s Calendar Review & Analysis Office (CRAO), will discuss their experiences optimizing OnCore calendaring workflows. With the OnCore calendar playing a central role for so many end-users, increasing calendar quality was identified as a high-priority goal with wide-ranging benefits. Kristen and Tim will highlight the collaborative practices that helped to jump-start the development of process efficiencies, share creative solutions that were identified in the process, and review challenges encountered along the way.

Maintaining billing compliance is a challenge within clinical trials. In this session, Jake Meyer will review common site practices that conflict with Medicare’s policies and best practices. These topics include hepatitis and HIV screening in oncology, maintaining consistency across your patient population, the use of Medicare’s ‘Seven Desirable Characteristics of a Clinical Trial’ decision memo, and accounting for the many new national and local coverage determinations.

In the constant efforts to accelerate drug development and bring treatments to market faster, collaboration between sites and sponsors is vital. In this session, Aidan Gannon of Advarra will provide strategies for sites and sponsors to ensure a positive site experience for industry trials. He'll discuss the importance of streamlined process, open communication, and a site-centric approach to technology to keep research moving forward.

Intermountain Healthcare recently implemented a Clinical Research Process Content (CRPC) billing grid integration between Clinical Conductor and their Cerner EMR. The integration allows them to centralize their billing workflows and improve billing compliance across their research portfolio. In this session, Anuja Gutal and Casey O'Hara from Intermountain will outline their implementation process and share lessons learned after launching the integration.

Presentations frequently address center-specific outreach strategies and various approaches to increase minority participation in clinical trials. Much less common are discussions of how best to track, calculate, report, and share minority clinical trial accrual rates within our centers. OnCore can be a valuable tool in such work. In this session, Nick Fisher of Siteman Cancer Center will discuss several different metrics that can be used to perform extensive analysis of minority clinical trial accrual and how OnCore can support such efforts. He will also explore how integrations with other data sources, including EMRs, can further advance these efforts. Finally, he will consider optimal ways to report data to key personnel within our centers as well as policies and procedures related to enforcement and accountability.

Since implementing the Clinical Conductor CTMS, Prism Health North Texas has improved financial management and reporting across their portfolio. In this session, Lauren Rogers, Director of Clinical Research, will discuss lessons learned in building budgets, tracking completed study visits, creating monthly reports, and tracking payments with the CTMS.

We will share our experience in rebuilding and optimizing the OnCore financials management at our site. We will discuss the evolution of our OnCore calendar builds and how we transitioned the process from our Informatics Team to our Pre-Award Team and recently to the Advarra BOS Team. We will share how we engaged Advarra for Financials Training to determine the best approach to restructuring and utilizing our OnCore Charge Master and building our final budgets in OnCore. This training, combined with our BOS calendar builds, has positioned us to more efficiently invoice out of the system and better manage our research billing compliance. We have also recently implemented Vendor Payables and will share our experiences with this new feature!

Duke successfully implemented OnCore® in May 2018, creating a standardized clinical research experience to manage research from protocol creation to project closeout. In this session, Denise Snyder will outline Duke's efforts to improve portfolio management and optimize data collection by measuring data entry efforts as part of their Clinical Research Unit (CRU) Scorecard. The CRU Scorecard was started several years ago to address areas that needed improvement across the research enterprise. Key areas include enrollment, CRU protocol review times, research practice manager review of OnCore use (subject visit tracking, summary accrual, minimum footprint), and financial practice manager review of OnCore financials (industry budgets, review and signoff, invoicing). Snyder will share how Duke used the scorecard to drive improvements across units in enrollment, operational adoption, and financial attention.

In many organizations, GCP practices remain on the clinical/regulatory side, while billing compliance remains on the finance side. When these teams collaborate, the organization can make the most of their internal resources decrease their clinical research operational risk and non-compliance. In this session, Dawn Pittinger of Moffitt Cancer Center will share strategies and experiences using this collaborative process to improve compliance across an organization.

Key performance indicators (KPI) provide sites evidence-based metrics to promote the health of their research sites. Monitoring KPIs offers an in-depth risk-based assessment to analyze and identify areas of practice to strengthen clinical research trial operations. As time is of the essence when deploying clinical trials, a site's ability to be agile with data metrics offers sponsors and CRO quick implementation timelines based on a site's past performances validated by KPIs. This presentation will discuss how to categorize, track, measure, and implement quality indicators within your business and clinical operation to monitor and track your KPIs to monitor your clinical research site's health.

Late in 2019, Cedars-Sinai Medical Center began the process of integrating their financial system with OnCore to maximize transparency and centralize clinical trial billing within the Office of Research Administration. Once completed, new budget and billing practices went into place in the middle of 2020. This presentation, led by Omid Zia and Sami Naber of CSMC, will discuss what they've learned on multiple levels, including items they became aware of during the technical process, how budget creation and builds have evolved, their new billing process, and the rollout to study teams across the institution. They will share where they are now and outline their next steps going forward.