Managing Clinical Trials Just Got Easier

September 19, 2011

OnCore, a Clinical Trials Management System (CTMS) that will facilitate a new level of sophistication and support for clinical and translational research, is up and running.

In a process that was spearheaded by YCCI, OnCore was chosen following an exhaustive search that included 22 vendors and involved 120 faculty members and staff. It has been successfully implemented in 36 institutions, 22 of which are National Cancer Institute designated Cancer Centers.

The implementation of a new CTMS is part of a major effort involving the School of Medicine, the Yale Cancer Center, and the Yale New Haven Health System to overhaul Yale's informatics infrastructure. Last July, Yale signed a multiyear contract with the Epic Systems Corporation to implement an electronic health record (EHR) system that is expected to transform patient care throughout the health system. OnCore will be linked to the EHR, providing investigators with access to comprehensive information that will be a boon to clinical research.

"I'm excited at the selection of a CTMS that can interface with the Epic system and provide the support we need to take clinical and translational research to a whole new level," said Thomas J. Lynch, Jr., MD, director of the Yale Cancer Center. "It's an important part of our strategy to develop new treatments for many diseases."

Yale negotiated with the OnCore vendor to include components that will be a boon to research, such as the automated population of lab values, a biospecimen management system, and a demographic interface that connects to Epic. Down the road, future integration will encompass a number of additional features, such as automated roadmap functions and automatic upload of data to SAS. These tools, which until now have not been available at Yale, are expected be of great benefit to investigators.

Clinical trials are increasingly difficult to administer and costly to undertake due to complex compliance, financial and ethical issues. The OnCore platform spans the entire clinical trials process, including protocol review, electronic data capture, and patient registries, as well as supporting patient safety procedures, and clinical research operations and reporting.

"Just as the EHR allows physicians to manage their patients' information electronically, OnCore will allow researchers to electronically manage the documents, procedures and vast amounts of data associated with clinical research," said Tesheia Johnson, MBA, MHS, YCCI's chief operating officer.

Yale Center for Clinical Investigation (YCCI), Yale Cancer Center, and other staff began using OnCore on July 8, 2011 for protocol entry and administration, subject enrollment and management, and serious adverse events and protocol deviation tracking. The go-live included the migration of six years of legacy data amounting to 365 protocols and 2100 subjects. Lessons learned from the Cancer Center implementation, as well as from other institutions, will lay the groundwork for OnCore's implementation throughout the remainder of the Yale enterprise, which will take approximately 18 to 24 months.

A website is now available online at https://medicine.yale.edu/ycci/oncore/ to familiarize Yale faculty and staff with OnCore and provide updates throughout its implementation. It contains an overview of the project, information about its functionality and training materials to help ease the transition to the new system.