Managing the Clinical Research Enterprise

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Protocol & Subject Life Cycle Management

The foundation of OnCore clinical research management, this module facilitates and provides the capabilities to set-up and activate studies, manage committees, verify subject eligibility, register subjects, monitor accrual, and report on studies.

Subject Safety Management

Centrally controls 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 & 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 financials management functionality to help ensure accurate and timely billing.

Study Financials Management

Manages financials for the life cycle of a protocol including budget estimation, standard of care versus research charge delineation, milestone-based payment terms, automated invoicing rules, invoice creation, and payment reconciliation. This module also includes an enterprise charge master.

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 on-line submission feature 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. A dynamic web page tied directly to the OnCore database, this module allows users to search and view select protocol information by criteria such as body site, and treatment type.

Custom Reporting Technology

Augmenting the rich collection of standard reports, institutionspecific custom reports are available via integration with the thirdparty report engine technology, JasperReports. Leveraging the builtin access and security controls maintained by the OnCore platform, reports can be produced as needed in a variety of file formats.

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