Clinical Trials Management System

Most research efforts still rely primarily on the use of paper, consequently one of the biggest opportunities for clinical research automation is to enable research collaboration to occur electronically. If a single system can support multiple studies and multiple departmental areas within a single system framework, collaboration can include increased efficiencies in training, security, system support and functionality that are superior to most Clinical Trials Management System (CTMS) applications employed in the past. A flexible, expandable, and comprehensive CTMS, called Velos, has been deployed to meet immediate requirements, and research collaboration is likely to follow. CTMS is set up to:

• Provide monitoring of many aspects of clinical trials including, but not limited to, study team members, study statuses, and patient enrollment;
• Provide capability to identify, schedule and track study patients;
• Provide up-to-date, comprehensive case report form (CRF) data;
• Provide billing interfaces for all study-related charges;
• Provide other sponsor-required reporting capabilities;
• Increase the flow of accurate patient information among all personnel and with referring physicians to increase patient safety and improve clinical outcomes;
• Improve the flow of accurate information for monitors, auditors, internal and governing agencies; and
• System must be HIPAA compliant and secure.

Velos provides a product called eResearch that is presently considered the best of breed for clinical trials management. Velos eResearch supports clinical research in all parts of the healthcare enterprise and within a broad diversity of clinical departments and functional needs. The system fundamentally improves the way data is collected, organized and shared.

The Velos eResearch application can export of study data in SAS format, Microsoft Excel, or as comma delimited files to transfer data sets into other statistical analysis software packages. The Velos eResearch application also allows for explicit study, user, and user group access definitions to determine which users have access to what data and whether they are permitted to create, read, update, delete or download each item of information stored in the Velos system. Authentication used in the Velos eResearch application is compliant with the UC Davis Health System password and security standards, and contains a mechanism fused with secure session management logic.

Velos eResearch is widely used at UC Davis School of Medicine Departments including the NCI-designated Cancer Center, The NIH-sponsored Clinical and Translational Science Center (CTSC), the MIND Institute, Internal Medicine and others. Velos is expected to replace the ISAAC study management tool at the MIND Institute.

Velos eTools, a companion product to Velos eResearch, empowers customers by giving them ownership and access to functions such as system configuration, data migrations, custom reporting and third-party data submissions.

Velos eSample, a specimen management system, provides investigators and pathologists with a comprehensive operations support system for managing specimen data and integrating specimen data with rich clinical data sets such as those captured in Velos eResearch.

UC Davis Clinical Trials Management System
2450 48th Street, Suite 2800
Sacramento, CA 95817

Phone: (916) 703-9183
FAX: (916) 703-9135

Director of CTMS
Michael Hogarth, M.D.
(916) 703-9185
michael.hogarth@ucdmc.ucdavis.edu

CTMS Project Manager
Paul Pannu
(916) 703-9183
paul.pannu@ucdmc.ucdavis.edu

Database Administrator
Steven Covington
(916) 703-9182
steven.covington@ucdmc.ucdavis.edu