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Clinical Research Support

OnCore

Key Features of OnCore

Key Features of OnCore
There are eight core components to the OnCore clinical trials management system. They are:

Protocol and Subject Life Cycle Management
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. The Effort Tracking console assists institutions with tracking staff effort from pre-activation through study closure.

Subject Safety Management
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.

Protocol and Subject Calendar Management
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.

Study Financial Management
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 module also includes an enterprise charge master. The Coverage Analysis module assists with maintaining billing compliance.

Electronic Data Capture and Data Management (EDC and CDM)
Provides flexible capabilities for the design, utilization, monitoring, and export of electronic case report forms (eCRFs) and the data they contain. This module gives granular control over clinical data and monitoring activities across the entire research center in support of investigator initiated trials.

Paperless Committee Management with ePRMS
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.

Study Information Portal
Supports community outreach activities by providing up-to-date protocol information to the general public and outside 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.

Custom Reporting Technology
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. Custom reports that support the needs of clinical and translational science institutes are also available.