New Clinical Trial Data System Supports Collaboration, Cost-Savings

EDC-CRDMS working group

Members of the working group that helped USAMRMC achieve the EDC-CRDMS. (Top row) LTC Lee Lefkowitz, PHC; Philip VanWerkhoven, USAMRIID; Lynn Stevens, USAMRIID; Capt. Bruce Barnes, USAMRMC; Maj. Jose Pizarro, PHC; Darrin Power, USAMRMC; (Bottom row) Paileen Mongelli, USAMMDA; Zainab Nanji, WRAIR; Jeanne Barkman, USAMRIID; Anna Marie Seale, USAMMDA; Nan Guo, USAMMDA; Heather Hedrick, USAMMDA; Carlos Vasquez, NRMC; Maj. Kirsten Smith, USAMMDA. (Photo by Ellen Crown, USAMRMC Deputy PAO.)

USAMRMC has updated its clinical trial records keeping with a new Electronic Data Capture-Clinical Research Data Management System (EDC-CRDMS).

EDC-CRDMS utilizes several Oracle commercial off-the-shelf products. Inform® allows USAMRMC to more efficiently develop, conduct and manage electronic data capture-based clinical trials. Utilizing Oracle's Central Designer® software, USAMRMC is able to accelerate trial development, increase trial efficiency, and more readily share clinical data with external partners, collaborators, and the Food and Drug Administration (FDA).

"This is a huge accomplishment," said Deputy Project Manager and EDC Working Group co-chair Capt. Bruce Barnes. "EDC will allow clinical trials at USAMRMC to be stored electronically, which allows for easier reporting, input and data management."

USAMRMC's Enterprise IT Project Management Office and others worked on the project for more than two years. The system became fully operational April 22, approved by Dr. Kenneth Bertram, Principal Assistant for Acquisition.

In addition to providing electronic data capture, USAMRMC has a requirement to conduct paper-based clinical trials in partner countries such as Kenya and Thailand, or where consistent web-based access is not feasible. Utilizing Oracle's Clintrial®, USAMRMC will be able to input the trial data captured on paper into electronic format, utilizing features to assure accurate data entry, and facilitating electronic storage and sharing of clinical trial data with partners and the FDA.

"I am proud of being a part of this productive and successful collaborative effort between so many USAMRMC organizations and the Naval Medical Research Center," said Maj. Kirsten Smith, director of the Clinical Support Services Division and co-chair of the EDC Working Group. "Obtaining, configuring, and fielding this capability will provide a valuable resource to our product development teams, external partners, and the DoD for years to come."

USAMRMC has established training and processes for use of the system, which are available for teams planning to use EDC-CRDMS for clinical trials.

Barnes added that there has been no official mandate for all clinical trials to utilize this system for its data management; however, with use of this system, organizations can expect significant savings over contracting out the service, which could mean more "research for less."

For more information, contact the eIT PMO at usarmy.detrick.medcom-usamrmc.other.eit-pmo@mail.mil or USAMMDA's Clinical Support Services Division at (301) 619-1106.

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Last Modified Date: 15-May-2013