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OmniComm Systems, Inc. Releases New Version of TrialMaster Suite With Dynamic Monitoring Functionality

July 02, 2012


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

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FORT LAUDERDALE, FL, July 17, 2012 – OmniComm Systems, Inc. (OMCM) announced the immediate availability of TrialMaster version 4.1.2, its flagship product for Electronic Data Capture (EDC). This latest version of TrialMaster introduces Dynamic Monitoring, a feature that allows organizations conducting clinical trials to significantly reduce their monitoring costs, while showing compliance with the FDA’s new draft guidance on risk-based monitoring. This feature allows customers to control how much of the data in a given trial needs to be verified against source documents, such as specifying that half the patients should have full monitoring and half should be monitored for critical variables only.  The specification can vary by investigative site, allowing the sponsor or Contract Research Organization (CRO) to focus its monitoring resources to maximize effectiveness.

This new release also features a variety of significant functionality enhancements including: major improvements to the management of laboratory reference ranges, an upgrade to LogiXML™ version 10 for ad-hoc reporting,  the ability to control security at the item level, and a new capability to attach images and other types of files to electronic Case Report Forms. These attached files are also included in the PDFs of patient data that are produced at the end of the study, allowing FDA reviewers to see images and scanned documents alongside the submitted textual data.

“TrialMaster already offers the industry’s most intuitive EDC product, providing sites an unequalled level of interactivity”, said Keith Howells, SVP of Development at OmniComm. “This new release provides tremendous additional benefits to the sponsor companies, notably allowing them to implement risk-based monitoring plans and thus drive down costs without impacting quality. We are looking forward to a speedy adoption of these new capabilities”.

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.