Benefits Include:
Organized Data Management
OnCore serves as a centralized platform for all study-related data, eliminating the inefficiencies of disorganized data storage. With critical information readily accessible, research teams can save time and make informed decisions.
Efficiency in Administration
By automating workflows and reducing redundant data entry, OnCore allows research teams to focus more on scientific breakthroughs instead of administrative tasks. For example, features like auto-study creation and auto-flagging of research subjects in EPIC, streamline processes.
Compliance Assurance
Maintaining compliance with regulatory requirements is crucial in clinical research. OnCore's built-in safeguards, alerts, audit trails, and e-signature capabilities ensure that research teams are always prepared for audits and meet reporting deadlines.
Enhanced Collaboration
Effective teamwork is essential for successful research outcomes. OnCore facilitates collaboration within and across institutions, improving communication and decision-making processes.
Data-Driven Insights
With OnCore's robust reporting tools, research teams can track study progress, optimize resource allocation, and inform their research with actionable insights derived from comprehensive data analysis.
Study Management and Tracking
OnCore provides a comprehensive platform for managing and tracking all aspects of a clinical study, from protocol design and study startup to subject tracking and study completion. Researchers can easily monitor study progress, identify potential bottlenecks, and make informed decisions to keep studies on track.
Subject Management
Efficient subject management is crucial for successful clinical trials. OnCore facilitates seamless subject recruitment, screening, enrollment, and scheduling processes, ensuring that valuable participant data is accurately recorded and securely stored.
Resource Allocation and Budgeting
OnCore enables research teams to optimize the allocation of personnel, equipment, and financial resources across multiple studies. This helps to maximize efficiency, reduce costs, and ensure that resources are effectively utilized throughout the research lifecycle.
Customizable Workflows
OnCore offers configurable workflows that can be tailored to the specific needs of different research protocols, therapeutic areas, and institutional processes. This flexibility allows research teams to streamline their operations and adapt to evolving requirements.
Integration and Interoperability
In addition to its integration with Epic EMR, OnCore can seamlessly interface with a wide range of other systems and data sources. OnCore is integrated with CLICK to facilitate the accurate and seamless transmission of IRB-related data to the study in OnCore. Financial Edge and PeopleSoft will also be integrated ensuring that financial teams supporting research have access to all relevant data and can leverage existing infrastructures and processes.
Differentiating OnCore and the EDC Module
Differentiating OnCore and the EDC Module
It's important to note that while OnCore is a comprehensive clinical trial management system, it does not serve as an Electronic Data Capture (EDC) system for collecting and storing detailed research subject data such as blood results, test results, questionnaires, or any data collected for analysis purposes. These granular research subject data elements are captured and managed within a separate module such as RedCap, which is specifically designed for electronic data collection.
OnCore's primary focus is on facilitating and streamlining the overall management of clinical research studies, including tasks such as:
- Study activation and amendment tracking
- Subject registration and enrollment
- Regulatory compliance tracking
- Study documentation management
- Financials and billing management
- Reporting and analytics
While OnCore does contain study-related data, such as subject demographics, visit schedules, and study milestones, it does not serve as a repository for detailed research-subject-level data collected during the study. This granular data resides within the EDC module, which is designed to support data entry, data validation, query management, and data exports for analysis.
OnCore and its other modules, like eReg, provide a comprehensive and efficient solution for managing clinical research studies while maintaining data integrity and compliance. eReg will be used to pull study documents from CLICK, and work through the electronic signature process, versioning, and document flow to OnCore.