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OmniComm Systems’ TrialMaster SDTM Export Utility Chosen as a Finalist for the 2012 SCDM Data Driven Innovation Award

September 17, 2012


Kuno van der Post Ph.D
OmniComm Systems, Inc.

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Fort Lauderdale, FL, September 17, 2012 – OmniComm Systems, Inc., one of the fastest growing companies in the Electronic Data Capture marketplace, today announced that its innovative TrialMaster Study Data Tabulation Model (SDTM) Export Utility has been chosen by the Society of Clinical Data Management (SCDM) as a finalist for its 2012 Data Driven Innovation Award.

Created in 2007, the Data Driven Innovation Award is presented once a year at the Society for Clinical Data Management’s Annual Meeting to recognize important innovations within the industry that impact the quality or efficiency of clinical data management efforts among clinical trial research.

The SCDM’s panel of non-partisan Clinical Data Management (CDM) experts reviews each entry to determine the impact on the quality and / or efficiency of a CDM’s work, whether that entry represents an innovative application of a process or technology, and whether that entry represents an active collaboration between a service / technology provider and a study sponsor or between internal teams.

The SDTM Export Utility was specifically designed to interface with OmniComm’s TrialMaster Electronic Data Capture (EDC) suite to automate and facilitate the generation of SDTM datasets for clinical trial analysis and submission.

The SDTM format has gained significant traction in the industry and is the FDA’s preferred format for submission of clinical trial data. The SDTM format consists of a number of standard “domains”, such as demographics and vital signs, each with standard variables of a standard name and data type. Because this structure is always the same, regardless of the therapeutic area and the method and format of data collection, the FDA can review the data with greater efficiency and speed. This in turn leads to shorter approval times.

“Most EDC vendors treat the generation of SDTM datasets as a separate programming exercise at the end of the study, which is needlessly inefficient.” said Keith Howells, SVP of Product Development for OmniComm. “By contrast, TrialMaster allows a study designer to map the source data to the SDTM format using a drag-and-drop mapping tool, which is much more productive and allows reuse across studies. Our customers are generating SDTM datasets within two weeks of study start, giving an enormous head start to the analysis process”.

This marks the 2nd time in the last three years that OmniComm’s technologies have been chosen as a finalist for this coveted award. The winner of the SCDM Data Driven Innovation Award will be chosen by a distinguished group of panelists at the SCDM Annual Conference taking place in Los Angeles, CA September 22nd-25th.

About OmniComm

OmniComm Systems, Inc. (www.omnicomm.com) provides customer-driven Internet solutions to pharmaceutical, biotechnology, research and medical device organizations that conduct life changing clinical trial research. OmniComm's growing base of satisfied customers is a direct result of the company's commitment to deliver products and services that ensure ease of use, faster study build, ease of integration and better performance. OmniComm Systems, Inc. has U.S. headquarters in Fort Lauderdale, FL and European headquarters in Bonn, Germany, with satellite offices in New Jersey and the United Kingdom, as well as sales offices throughout the U.S. and Europe.

Safe Harbor Disclaimer

Statements made by OmniComm included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as the Company's ability to obtain new contracts and accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration of projects, and internal issues at the sponsoring client, integration of acquisitions, competitive factors, technological development, and market demand. As a result, actual results may differ materially from any financial outlooks stated herein. Further information on potential factors that could affect the Company's financial results can be found in the Company's Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.