PIs will have a centralized platform to efficiently manage and oversee their clinical trials, with seamless access to detailed trial data and tools for tracking progress. OnCore enhances collaboration with study teams, streamlines the monitoring of regulatory compliance, and reduces the risk of erroneous billing of research subjects.

• Streamlined Workflow: OnCore will centralize your workflow, making it easier to manage everything from subject data entry to tracking and reporting—all in one place. This means less time switching between systems and more time focusing on the details of your studies.
• Stay On Top of Milestones: OnCore's configurable notifications will alert you to important study or subject milestones, ensuring you never miss a critical moment. Plus, the task lists feature will help you stay organized, offering a checklist approach to your daily tasks across all your studies, so you can keep everything on track with ease.

OnCore, as a comprehensive clinical trial management system (CTMS), will significantly impact regulatory staff in clinical research by streamlining and enhancing various aspects of their work. The following are a few examples of the benefits of OnCore:
• Centralized Document Management: regulatory staff will benefit from a centralized repository within OnCore where all essential documents (IRB Approvals, informed consents, regulatory submissions) can be stored and easily accessed.
• Improved Compliance: facilitates real-time tracking of regulatory submissions and approvals, allowing regulatory staff to monitor compliance with protocols and regulations more effectively.
• Automated Workflow Processes: Monitoring: automates routine tasks associated with regulatory management, such as tracking submission deadlines, sending renewal date reminders, and generating regulatory reports.
• Enhanced Communication and Collaboration
• Audit Readiness: comprehensive documentation and tracking capabilities enhance audit readiness

Coverage analysis within OnCore is a critical process that ensures accurate delineation of costs associated with clinical trials, determining which expenses are covered by the sponsor, insurance, or the participant. The information entered here will flow to Epic and ensure accurate billing and compliance.
The CA will also complete the QCT Checklist to record the rationale used to determine whether the study qualifies according to Medicare guidelines.

Serves as the main communication liaison for a research site, coordinating interactions and logistics in the absence of a centralized study contact model. Identified as the contact on the Advarra Site Information Portal (SIP) page in CTMS, and distinct from other roles due to their primary focus on site-level communication which includes research subject recruitment materials, referral forms, or links to external recruitment databases of resources.

Data managers will oversee the data management process, including data collection, validation, and analysis. They will ensure the integrity and confidentiality of study data so accurate data can be extracted and valid conclusions can be obtained.
The study team will need to ensure they are efficient with data entry for data managers to properly perform their roles.

OnCore will facilitate data monitoring reviews, data locks, query resolution, and data clean-up processes, helping to build and maintain data integrity throughout the study lifecycle.
Study monitors will have access to comprehensive study data and tools to streamline their monitoring activities.

These teams will be involved in various aspects of OnCore implementation, such as budgeting, resource tracking, and streamlining billing processes through integration with the other financial systems, i.e., Epic, Financial Edge, and PeopleSoft. Once these steps are completed, the study coordinators can set rules within OnCore to automatically create invoices for specific milestones, or manually create invoices to be sent for billing.

Staff will familiarize themselves with relevant OnCore functionalities and adapt their workflows accordingly during the training process. The financial teams may need to utilize OnCore's Financial Console to manage budgets, track milestones, and generate invoices for sponsored studies.

Affiliate sites and Healthcare Partners will now have a central location to capture all information on their research participants and site activities. These personnel will have appropriate access rights and permissions and will be restricted to only the activities they are authorized to view and perform.