A clinical research management system (CTMS) is an enterprise software system that is used to organise and monitor clinical research activities inside an institution. This CTMS (OnCore) is used to manage clinical research at the Fred Hutch Cancer Centre and the University of Washington, as well as across both institutions.
OnCore CTMS provides a broad range of functions that will enhance clinical trial conduct in both cancer and non-oncology:
Administration of clinical research
OnCore functions as a centralised resource that is made available to study teams, central offices, and clinic teams that are responsible for carrying out the day-to-day activities necessary for the execution of clinical research. The system’s functions include the management of study start-up and modification processes, the handling of study financials and billing compliance, the provision of access to study materials, the monitoring of subject activity, and the management of study start-up and modification procedures.
OnCore is able to standardise procedures for research billing, including sponsor billing and subject visit monitoring. In order to facilitate the approval procedures for study billing, the Study Billing Grids that have been generated in OnCore are sent to the UW/Fred Hutch Epic Electronic Medical Record (EMR) system.
FRONT-ENDS / INTEGRATIONS
Both the Epic EMR system used at UW/Fred Hutch and the Vestigo system used by the Investigational Drug Service (IDS) at Fred Hutch are connected to OnCore. This allows for the interchange of billing information as well as information about subject status, patient data, and staff job assignments for procedures.
REPORTING / ANALYSIS
Because OnCore offers powerful data and reporting capabilities, it is much simpler to gather the information and metrics that are necessary to fulfil the reporting requirements of the National Cancer Institute (NCI), as well as billing and financial operations and start-up dates for clinical trials.