Major Academic Medical Center Implements New CTMS

Major Academic Medical Center ImplementsNew Clinical Trials Management System

Strategic informatics business model includes programs of organizational readiness -

Fremont, California, USA - October 9, 2008 - Velos announced today that the Duke University Health System (DUHS) has completed a successful go-live of the Velos eResearch system. This clinical trials management system is now operational with a basic set of functionality and in cancer research.

The go-live completes beginning phase activities related to DUHS’ enterprise-wide strategic business model of clinical trials informatics. Velos eResearch will help further execution of site based clinical research, financial standards and compliance with regulatory responsibilities. The Velos platform will provide infrastructure for strategic directions that include collaboration with other institutions on a national and international scale.

DUHS is using Velos eResearch to register protocols and subjects for all cancer trials. The first part of this phase began with registration of new protocols and subjects and most recently completed with the conversion of all current and historic cancer protocols and subjects. Implementation will continue by therapeutic area and it is intended that all new research will go into the system. “At that time, we’ll be managing all research subjects in a common system and taking advantage of the financial aspects of the Velos product,” stated Steve Woody, associate chief information officer for translational and clinical research for Duke Medicine. “We’ve laid out the next logical set of functionality. It’s a pretty healthy list that includes going to other disease specialties.”

Interface Development

Informatics objectives include integration of disparate systems, which has been central to the Velos/Duke development partnership. “If we can provide interfaces through a common portal, then we’ve reduced the burden on our researchers, research staff and support functions,” said Dr. Wesley Byerly, associate dean, Research Support Services. “This will allow them to focus on their patients and on the research.”

DUHS will use Velos in conjunction with other activity – particularly start-up activity – moving a protocol through approval. As part of the role of DUHS in the CTSA (Clinical and Translational Science Award from the National Institutes of Health), DUHS is working on a standardized vocabulary to promote the integration process.

Among interfaces built to date is the Medical Record Number (MRN) Lookup Interface to provide consistency of information and lighten the workload of clinical trial coordinators. Users enter an MRN and pull back the demographic information from the medical record.

Organizational Readiness

DUHS informatics strategies are being carried out in a sequence of phases to ensure that proper groundwork is in place. Organizational readiness is a key factor. That includes restructuring some traditional clinical trials execution models. DUHS has organized its site-based research into 12 groups in which each has its own medical leadership, clinical operations and financial leadership. Site Based Research groups (SBRs) are aligned therapeutically so that there is an SBR for cancer, one for pediatrics, and so forth. Instead of having various research efforts, each going in a different direction, these will be overseen by their own home SBR.

On-site training for more than 120 end users took place two weeks prior to the first go-live phase of Velos eResearch in October 2007. The four-day training schedule targeted three user groups including coordinator, regulatory, and general groups consisting of various other user types.  Each coordinator and regulatory training session was hands-on and 2-3 hours in length.

“We’ve enjoyed immensely working with Duke University Health System,” stated John S. McIlwain, President and CEO of Velos, Inc. “We’re honored to contribute to their informatics initiatives as they improve the efficiency and quality of their clinical trials processes.”

About Velos
Velos, Inc. is thetrusted clinical trial management resource for investigators, sponsors and academic leaders throughout the U.S.  Its customers include 21 of the top 25 academic medical centers and research institutions. These customers receive 30 percent of all NIH extramural grants. Founded more than ten years ago, Velos offers an entire suite of products, including eResearch, eCardio, eTools and eSample.

Velos eResearch is deployed for clinical research in all parts of the healthcare enterprise and supports a broad diversity of clinical departments and functional needs. The system fundamentally improves the way data is collected, organized and shared. A pure Internet technology platform, Velos eResearch harnesses advanced powers of the Internet to enable research sites, sponsors, and patients to collaborate in a secure, integrated system platform.  System users are freed of redundant data entry and related time delays associated with most clinical research today. With emphasis on workflow, Velos integrates the clinical, administrative and financial information needs of research management.

Founded in 1996, Velos is privately held with headquarters in Fremont, California.  For more information, visit www.velos.com.