This hands-on workshop, led by Advarra's training team, will walk attendees through several calendar-building scenarios. Participants will practice building segments and visits and tackle common calendar troubleshooting scenarios. In this hands-on workshop led by Advarra experts, learners will walk through post-award financial workflows in OnCore. This includes creating invoices, applying payments, and reconciling vendor payables. The workshop will include the new Sponsor Payments functionality.

AI is rapidly taking the clinical research industry by storm. It can be hard to keep track of all of the tools available, or even know which ones could best suit your needs. This session will cover different types of AI or AI-like tool sets used currently (or in development) to address operational needs in clinical research administration. Learn how AI can help with administrative data analysis, aid in prompt-a-thons for advancing local team usage and idea generation, and tackle complex repetitive actions such as QCT, MCA, or billing designation decisions.

CEU available.

In this session, presenter Erwin Go will share how his team utilizes tools in OnCore to improve efficiency for study teams at Inova. Erwin will show how to use tools such as separate calendar line segments for imaging, adding alternative procedures to a calendar line up, optional segments for unscheduled visits, and more. He will also provide OnCore tip sheets for study teams to reference as they work to navigate studies in OnCore more efficiently.

CEU available.

Recent technical advancements and decreasing costs have made artificial intelligence (AI) accessible to nearly anyone. Such prevalent use has both benefits and limitations. However, this raises caution for its use in high-risk applications, such as in clinical research settings. It’s imperative for clinical research professionals to be aware of existing and emergency regulatory and ethical frameworks surrounding AI with medical products. In this presentation, David Vulcano of HCA Healthcare will outline why responsible AI oversight is crucial, as well as discuss encompassing regulatory issues, organizational oversight, and professional standards.

CEU available.

The University of Kentucky and Avacare leverage role-based training models to provide focused and efficient staff training for research applications. This practice prepares staff to use applications with the functionality required to perform their duties as soon as they return to their teams. By attending this presentation, trainers and system administrators will learn about methods to increase efficiency during the research technology onboarding process from user account creation to strategies for creating and maintaining a training environment. Attendees will also learn about maximizing training resources by utilizing a blended approach, including instructor-led training, Advarra University, training videos, and tools such as access request forms, and Microsoft Bookings. Strategies for tracking and reporting training will also be discussed.

CEU available.

Ensuring billing compliance is an important, yet extremely complex process in clinical research. While it can be intricate, there are tools available to help in planning and executing billing compliance. In this session, learn how using OnCore streamlines billing compliance workflows, while also providing greater visibility so everyone can better understand the billing process.

CEU available.

Advarra recently released the 2024 Site-Sponsor-CRO Collaboration Survey Report. Survey respondents weighed in on the top challenges impacting their collaboration among sites, sponsors, or CROs. This session goes in-depth on the findings and recommended actions, offering organizations specific actions to overcome barriers, improve trial execution, and advance clinical research.

CEU available.

This panel session features leaders from the Onsemble Community discussing the industry's biggest challenges and how sites are facing them head on. The discussion is supported by data and analysis from Advarra's recent Site-Sponsor-CRO Collaboration Survey Report. Panelists will provide actionable insight into how their organization is navigating these challenges, improving collaboration, communication, and overall trial execution.

CEU available.

Just like the famous comic-book series, how do we align our future state with our current state? In the beginning of any project the best you can do is a safe and effective implementation. The future goal is then to find efficiencies, foster adaptability and buy-in, as well as implement a practical and sustainable training program. Discover the steps you can take today to build an ideal state tomorrow.

CEU available.

In this session, presenters from UC Davis will walk through how their organization transformed financial management processes for clinical trials using OnCore, turning a previously chaotic and decentralized system into a streamlined, centralized process. They will explore how they leveraged existing OnCore fields, developed custom Jasper reports, and revamped the invoicing workflow to ensure separation of duties, audit compliance, and improved financial reporting. Attendees will gain insights into how UC Davis' innovative use of OnCore's capabilities enhanced efficiency, reduced administrative burdens, and significantly improved payment reconciliation. These solutions are scalable and adaptable for other organizations looking to optimize financial workflows.

CEU available.

The FDA is moving towards a mandate of the use of a sIRB in Q2 2025 for multicenter trials. The mandate states sites must follow the sponsor's choice of the IRB. This is following a similar suit from the NIH policy for the use of sIRB that went into effect in 2018. Institutions need to prepare their processes to ensure they are aligned with the requirements. This session will help attendees understand the importance of establishing a workflow to streamline process while ensuring compliance with both federal and institutional guidelines.

CEU available.

Do you have protocols that just don't seem to fit in OnCore? A budget format you've never seen before? Do you ever wish sponsor protocols were built with OnCore standard functionality in mind? While most calendar and financial aspects can be easily built in OnCore, some scenarios require some creativity. This presentation will focus on a variety of strategies the Fred Hutch/University of Washington OnCore team has implemented to tackle the uncommon and complex protocol and budget scenarios. Presenters will describe their rationale behind the workflows they've implemented to accommodate cases including crossing over to a new therapy from follow-up, multiple screen fail payments, and a billing grid integration with an EMR.

CEU available.

The University of Kentucky has developed an in-house process to perform the billing review of all clinical research through implementing a sustainable, process-based team structure. This presentation will walk through the four principles this process is based upon. Additionally, this presentation will cover the administration and billing review of the protocol and study content – including protocol review, developing calendars or initial OnCore data entry, and coverage analysis or billing grid processes taking precedence over individual tasks. Attendees will be able to apply process improvements to enhance their own organization’s billing integrity program.

CEU available.

In this panel discussion, users of Advarra eReg will discuss strategies for getting the most from the system. They will outline how their sites have improved efficiency through their use of eReg, explore best practices for new and experienced sites, and highlight how they have continually improved their use of the system over time. They will also share integration strategies, discussing how connecting eReg to OnCore and other internal systems can help improve productivity, data quality, and compliance.

CEU available.

Research sites sometimes struggle to get full user engagement and adoption when implementing enterprise technology, and a CTMS is no different. Combined with high turnover, the need to support remote team members, and other factors, this challenge has grown in complexity over the past few years. In this session, members of the Onsemble Community will share their strategies for improving user adoption and engagement within their CTMS. They will also share the downstream impacts of their efforts, including how they leverage improved data and metrics to make more informed, strategic decisions.

CEU available.

In this session, representatives from Hackensack will share how their team utilizes task lists in their study startup process. They will cover how their task lists are set up to track budget and contract negotiations, along with any other reviews that may be applicable. In addition, they will discuss how it allows Hackensack to have a comprehensive view and timeline of the study startup process via reports, and how study teams can gain clarity on project statuses through this method.

CEU available.

Representatives from Duke School of Medicine Finance and Duke Office of Clinical Research will present a two-part session highlighting how Duke has leveraged OnCore to centralize and streamline study startup and financial tracking in a decentralized environment. Part one will cover OnCore’s role in centralizing and streamlining clinical trial startup. Part two will highlight OnCore Financials’ role in providing visibility and key metrics across the institution. In addition, the team will share how Duke has achieved financial visibility and trend key metrics across the institution.

CEU available.

Note: This is an extended session. If you choose to attend this session, please do not register for a session in the following block to avoid overlap.

Gear up for game day with the University of Michigan as we unveil our interactive football playbook approach to CTMS Tech Talks!  Just like a winning team adapts their strategy, UM has tackled the challenge of re-engaging users by shifting from a traditional super user group to dynamic, quarterly meetings open to all players.    At Michigan, our CTMS Tech Talks empower end users through engaging discussions, practical skill-building activities, and collaborative problem-solving—all designed to address the unique challenges busy study teams face in a remote work environment. Just as every player is crucial in driving the ball toward the end zone, every user's effort is essential in enhancing accuracy, streamlining clinical trial operations, and ensuring compliance with billing workflows. Get ready to call the plays and break through the defensive line together— we play to win!

CEU available.

UC Davis Health has focused on increasing integration with other research applications to minimize manual reentry of data and improve efficiencies for research staff. Besides the standard EMR integrations of Subject Demographics, RPE and CRPC, UC Davis also implementing the financials integration (going live in January 2025), as well as exploring the FHIR SAE interface. In this session, Brian Scates from UCD will review the advances we have made with automation. He will share how, using specific automation software, his team created scripts enabling mass loads of subject accrual data, creating test subjects in OnCore, and importing subjects into trials. He will also share how they are continuing to expand these capabilities to allow more data to be entered without manual work and re-work by research staff.

CEU available.

Clinical trials take significant time and resources to activate. With an estimated 20-50% of protocols closing at a site without a single enrolled participant, considerable resources are wasted. While not mandated, feasibility reviews are being utilized by many organizations to minimize the risk of opening studies that ultimately will fail. Stage-gate process, a framework described in industrial organization management, can help identify projects early that are likely not to succeed and stop them before extensive resources are invested, freeing those resources to support other projects more likely to succeed. This presentation will discuss the stage-gate framework, provide tips on processes that can be used to implement a feasibility process, and provide metrics and data organizations can use to drive the analysis empirically.

CEU available.

In this session, Josh Plassmeyer of UPMC will outline the TWAINS (Trial Workload Analysis Instrument) at Hillman Cancer Center: a custom report and data summary dashboard designed to collate tasks completed at all stages of trial implementation, operation, and close out. The TWAINS has allowed management to assess workload, completed vs anticipated, to make more educated decisions with overall staffing, budgeting, and quality control as clinical trials continue to increase in complexity. Josh will walk through how the TWAINS works for them and enables approximately 200 staff to continue to have workload assessments performed in real time to effectively distribute work amongst them.

CEU available.

In today's competitive and rapidly evolving pharmaceutical research landscape, clinical trials face increasing pressure to meet shortened activation timelines. With numerous teams and stakeholders involved, the complexity of managing trial activation is continually being tested and refined. Traditionally, the Holden Comprehensive Cancer Center relied on legacy Excel systems and OnCore to track milestones. This approach posed challenges in maintaining data consistency, centralization, and overall trial transparency, limiting our ability to effectively track, report, and share pitfalls and progress without improved data-driven outcomes. This presentation explores the development and implementation of a task management system using OnCore as a tool to focus on ensuring consistent input of data, which enhances our ability to understand and streamline the activation process.

CEU available.

Prior to OnCore implementation, Johns Hopkins Medicine (JHM) did not have a central location for potential participants to search for what research studies are available. This presentation outlines how OnCore’s expanded functionality has empowered JHM to create a new platform, allowing for importing and housing clinical trials site within the JHM enterprise. Through this recruitment portal, patients can easily locate faculty members for clinical care while promoting wider and more diverse recruitment into clinical trials conducted within JHM.

CEU available.

The bi-directional integration between REDCap and OnCore utilized by Stanford eliminates the need for duplicate data entry when registering participants in both systems. By generating a daily list of discrepancies between registered participants in each application, study teams can efficiently synchronize subject lists and demographics. The integration will give study teams an easier time registering the participants in OnCore if they are already using REDCap and vice versa. This automated process leverages the OnCore APIs, ensuring security throughout. One of the objectives of this initiative was to develop an external module to share with other REDCap and OnCore institutions via the REDCap External Module Repository. This presentation dives into the technical architecture of this integration and provides a detailed, step-by-step demonstration of its functionality.

CEU available.

All too often we find ourselves the passenger in the car of change management and it turns out there isn't a driver, and the car is already in motion. While trainers don't typically think of change management as being part of our job, the reality is it frequently becomes our responsibility. In this session, Advarra's Cassie Hemmann will show how you can improve change management and boost user adoption through your training.

CEU available.

This presentation offers an in-depth overview of the implementation and use of Advarra Analytics for OnCore at Arkansas Children’s Research Institute (ACRI), emphasizing how teamwork both within ACRI and with Advarra has driven the successful adoption of the Analytics platform. Being part of the Cloud implementation, this session will explore how assembling the right team and collaborators has enabled enhanced data visibility, change management, process development, and user adoption throughout our research operations with the implementation of the Analytics platform.