In the world of clinical research, effective trial management is crucial for academic medical centers and cancer treatment facilities. With the complexity of clinical trials, especially in oncology, strong financial oversight is necessary. Clinical Trial Management Systems (CTMS) have become vital tools, helping institutions ensure compliance, improve operations, and enhance patient safety and financial management.
Clinical Trial Management Systems are meant to support the planning, tracking, and management of clinical trials. Institutions focused on oncology and complex medical research need comprehensive solutions to manage operational efficiency and compliance mandates. The OnCore Clinical Trial Management System, developed by Advarra, is a widely adopted solution in this area, used by more academic medical centers and cancer centers than any other system.
CTMS platforms typically include centralized billing processes, streamlined budget management, oversight of study lifecycles, and comprehensive analytics capabilities. These functions help coordinate among multidisciplinary teams, which is essential for conducting research in compliance with regulatory standards while maintaining financial health.
A key benefit of CTMS like OnCore is their ability to centralize billing information. Academic centers and cancer treatment facilities face unique billing challenges. These include varying protocols for patient billing, inconsistent invoicing practices for sponsors, and the need for effective financial compliance.
Kelly Anastasio, Senior Associate Director at the Yale Center for Clinical Investigation, noted significant improvements in billing compliance due to the integration of OnCore with their existing electronic medical record system, Epic. By centralizing billing processes, institutions can enhance their budgeting capabilities and streamline the routing of financial documentation. This leads not only to improved billing compliance but also reduces the risk of financial discrepancies that can arise from fragmented information.
Visibility into trial finances is important for medical practice administrators and owners seeking ways to optimize their resources. CTMS platforms provide real-time dashboards that offer business intelligence features, enabling professionals to analyze accrual rates and identify trends. This capability aids in operational planning and allows organizations to make decisions based on clear operational data.
Additionally, CTMS solutions help stakeholders manage budgets more effectively, revealing trends that can impact overall financial performance. Institutions can evaluate the financial health of specific trials to determine which projects are successful and which may need adjustments.
As healthcare evolves, the integration of advanced technologies into clinical trial management is essential. In this context, artificial intelligence and automation play important roles in enhancing trial efficiency.
AI technologies can automate routine administrative tasks such as scheduling, document management, and basic reporting functions. This shift reduces the burden on clinical trial staff and allows them to concentrate on more strategic decision-making aspects of trial management. The OnCore CTMS, for instance, features built-in workflow automation capabilities that improve communication among team members and ensure timely execution of critical tasks.
The adoption of AI-driven insights in these systems can lead to better study designs and adaptive trial methodologies. By analyzing historical data, AI can spot patterns that may improve patient recruitment strategies or resource allocation. This data-driven approach promotes informed decision-making, optimizing trial outcomes while ensuring financial accountability.
Despite the advantages offered by CTMS tools, institutions still face challenges in effectively adopting and implementing these systems. A significant obstacle is the cost of integrating a CTMS into existing infrastructures. The licensing fees for tools like OnCore vary based on the chosen modules and the organization’s protocol volume. Institutions must align their CTMS choice with their budget constraints and operational needs.
Additionally, the complexity of integrating a CTMS with existing EMR systems requires careful planning and staff training. A successful integration is crucial for realizing the full benefits of a CTMS, especially regarding financial oversight and operational compliance.
The communal aspect of clinical research is important. The Advarra Onsemble Community provides a platform for clinical research professionals to share best practices and address challenges together. By leveraging insights and experiences from a network of leading centers, administrators can access knowledge that helps improve their financial oversight capabilities.
This peer-driven approach to problem-solving is important for organizations in a competitive environment, where continuous improvement is necessary. The collaborative nature of the Onsemble community promotes shared learning, helping organizations identify common issues in financial oversight and find solutions to enhance efficiency.
CTMS solutions like OnCore offer flexibility, allowing institutions to tailor their subscriptions based on the modules relevant to their operational needs. This adaptability is especially significant for academic medical centers and cancer centers, which may conduct a varying number of active trials, often ranging from 50 to over 500.
By customizing their CTMS solutions, healthcare institutions can better align their financial management practices with specific research activities. This includes integrating clinical research management, biospecimen management, or billing compliance modules.
OnCore CTMS is a widely used system developed to manage clinical research effectively, focusing on compliance, operational efficiency, and coordination across research institutions.
OnCore centralizes billing information, enhancing consistency, budgeting, and streamlining routing, thereby improving compliance in billing operations.
It improves visibility and financial oversight in clinical research, allowing institutions to manage studies effectively with standardization.
Yes, OnCore integrates seamlessly with EMR systems like Epic and Cerner, increasing patient safety and operational efficiencies.
OnCore enables oversight of the study lifecycle from protocol setup, subject screening to study close-out, facilitating smooth operations.
The system offers comprehensive dashboards for actionable insights, enabling organizations to make informed strategic decisions based on operational data.
It mainly serves academic medical centers and cancer centers conducting 50 to 500+ active trials with needs in clinical research management.
The licensing fee depends on the modules licensed and the volume of protocols, with a subscription covering license and maintenance.
An enterprise license includes clinical research management, billing compliance, and many integrations, while some modules are available separately.
Advarra fosters collaboration through the Onsemble Community, allowing researchers to share best practices and tackle industry challenges together.
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