Academic medical centers, CTSAs, research hospitals, and cancer centers confront challenges in clinical research management that are distinct from those of pharmaceutical companies and contract research organizations. They contend with hundreds of trials at once in an environment where there are many other, often competing, concerns ranging from limited resources to meeting ever-changing regulatory requirements.
OnCore® supports best practices and operational workflows to help institutions meet their goals.
The foundation of OnCore clinical research management, this protocol and subject life cycle management functionality provides the capabilities to set up and activate studies, manage committees, verify subject eligibility, register subjects, monitor accrual, and report on studies. The Audit Console enables organizations to manage internal audits.
Institution-wide oversight for safety monitoring activities with automated notifications within the protocol context or across all protocols. Notifications are based on key regulatory and safety functions including AE and SAE tracking, Outside Safety Report tracking, and IRB reporting.
Calendars maintain study parameters including treatment administration, evaluations, and data collection schedules. Subject-specific calendars are automatically generated to provide subject visit tracking which directly drives financial management functionality to help ensure accurate and timely billing.
Manages financials for the life cycle of a protocol including budget negotiation, standard of care versus research-related charge delineation, milestone-based payments, automated invoicing rules, invoice creation, and payment reconciliation. This functionality also includes an enterprise charge master. The Coverage Analysis module assists with maintaining billing compliance.
Learn more about Study Financial Management in OnCore.
Provides flexible capabilities for the design, utilization, monitoring, and export of electronic case report forms (eCRFs) and the data they contain. This functionality provides granular control over clinical data and monitoring activities across the entire research center in support of investigator initiated trials.
Learn more about EDC/Data Management in OnCore.
OnCore features integrated functionality for tracking staff effort throughout a study, from pre-activation through study closure. This can assist institutions with effectively budgeting and negotiating for clinical trials, establishing performance benchmarks, and supporting requests for more staff or funds.
Learn more about the Effort Tracking Console in OnCore.
An electronic system for submitting, tracking, reviewing, revising, and approving clinical trials by a scientific review committee. The online submission and review console offers immediate access to electronic protocol documents, eliminating the need to track, copy, and collate multiple binders for reviewers.
Supports community outreach activities by providing up-to-date protocol information to the general public and referring physicians. Dynamic web content tied directly to the OnCore database allows users to search and view select protocol information by criteria such as disease type or treatment type.
Augmenting the rich collection of standard reports, institution-specific custom reports are available via integration with the third-party report engine technology, JasperReports. Leveraging the built-in access and security controls maintained by the OnCore platform, reports can be produced as needed in a variety of file formats. Customizable dashboards provide quick access to protocols, subjects and reports.