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OmniComm’s EDC Technology to Serve Central Role in Infectious Disease Study
Fort Lauderdale, FL - A large nationwide infectious disease observational study in Europe will receive electronic data capture (EDC) technology and related services from OmniComm Systems, Inc., a leading provider of clinical data management technology. As an integral part of the innovative study, a European research hospital selected OmniComm’s TrialMaster EDC to integrate privacy-protected patient data from the hospital’s electronic health records, a process known as eSource.
The study is unique because 100 percent of the research data will be pulled from electronic health records, as opposed to traditional paper sources. Once the data is imported into TrialMaster, the study will be conducted using OmniComm’s EDC technology. TrialMaster will be used as a data management engine - to aggregate, monitor, review, analyze, report and submit study data to regulators.
“This infectious disease study is innovative, and TrialMaster’s role in the project is unique for several reasons. The role of EDC becomes more focused on backend data management and review, as opposed to frontend data capture,” said Ken Light, executive vice president, professional services at OmniComm Systems. “We are extremely proud that the European research hospital is leveraging TrialMaster for the study of a major infectious disease. We are pleased to be partnering and working with such a world- class organization.”
Electronic source data guidance issued by the Food and Drug Administration in 2013 and the European Medicines Agency in 2010 opened the door and set new standards for how data can be gathered for clinical trials and studies. Those guidelines now allow researchers to pull data directly from e-records and mobile devices, while also providing strict safeguards for protecting patient privacy. For example, to maintain patient privacy, the European hospital will remove patient identities prior to exporting the electronic data into TrialMaster.
There are several benefits of this method of data capture, including improved quality of data, greater efficiency and enhanced timeliness. OmniComm was selected for the project because of these factors:
In fact, OmniComm’s expertise in integrating electronic medical record (EMR) systems was a key factor in the selection decision. Data captured from the research hospital’s EMR will automatically import into TrialMaster. This comprehensive eSource solution will help the institution realize the following:
About OmniComm Systems, Inc.
OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive solutions for clinical research with an extensive global experience from over 4,800 clinical trials. For more information, visit www.omnicomm.com.