What is a Clinical Trial Management System?

A clinical trial management system (CTMS) is an enterprise software system used to manage and track clinical research activities within an institution. This CTMS (OnCore) serves as a single, centralized, web-based resource used to manage clinical research conducted within or across Fred Hutch Cancer Center and University of Washington.

Features

OnCore CTMS provides an extensive range of functionality that will strengthen the conduct of both oncology and non-oncology clinical trials:

Clinical Research Management

OnCore serves as a centralized resource for study teams, central offices and clinic teams performing the day-to-day activities required during the conduct of clinical research. The system is used to manage study start-up and amendment activities, track regulatory approvals, provide access to study documents, track subject activities and manage study financials and billing compliance.

Billing Compliance

OnCore standardizes study billing processes, including sponsor invoicing and subject visit tracking. Study Billing Grids built in OnCore are sent to UW/Fred Hutch Epic Electronic Medical Record (EMR) system to support research billing review processes.

Integrations / Interfaces

OnCore is integrated with the UW/Fred Hutch Epic EMR and Fred Hutch Investigational Drug Service (IDS) Vestigo systems, facilitating the exchange of billing information, subject status data, patient demographics and protocol staff role assignments.

Reporting / Analytics

OnCore provides robust data and reporting functionality, streamlining the collection of data and metrics used for clinical trial start-up timelines, billing and financial operations and National Cancer Institute (NCI) reporting requirements.