SOURCE: OmniComm Systems, Inc.

January 09, 2007 10:00 ET

Proven Informatics Solutions Provider for the National Institutes of Health (NIH) Partners With Premier EDC Company to Deliver 1st of Its Kind eClinical Solution for Drug Development

CTIS, Inc. and OmniComm Systems, Inc. Sign a Strategic Alliance Deal to Offer Clinical Trial Sponsors a Complete Trial Research and Management Informatics Integration Initiative

FT. LAUDERDALE, FL -- (MARKET WIRE) -- January 9, 2007 -- OmniComm Systems, Inc. (OTCBB: OMCM), one of the fastest growing companies in the EDC marketplace, today announced that it will partner with Capital Technology Information Services, Inc. (CTIS) to form an integration initiative between OmniComm's TrialMaster® and CTIS' proprietary healthcare informatics framework called Trial Bridge™ that supports the largest research organization in the world. The partnership unites OmniComm's First in Functionality™ EDC system, a feature and function rich Electronic Data Capture (EDC) solution for clinical trial data management, with CTIS' Trial Bridge™ framework, currently utilized by CTIS in providing comprehensive clinical trials informatics support to the largest Institutes at the National Institute of Health (NIH) including the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Disease (NIAID) for the past fifteen years.

CTIS addresses the business and regulatory requirements of drug development and testing from pre-clinical to IND filing to NDA submission. Their unparalleled industry experience encompasses 850,000 patients, 100,000 documents, 25,000 physicians, 9,000 sites, 1,000 drug agents and 10,000 protocols. The Trial Bridge framework provides a central point that connects networks, sites and PIs allowing Sponsors and CROs better access and management of all trial related data. The Trial Bridge framework includes numerous components including eProtocol development, IRB management, investigator administration, enrollment, tracking, reporting and safety management of adverse events (AEs) all integrated and presented in an executive dashboard providing vital signs management at all levels.

"CTIS is committed to patient well-being by utilizing Internet based solutions that improve the quality, efficiency and safety of clinical trials resulting in improved outcomes management and increased Return on Investment (ROI)," said Raj Shah, Chairman and CEO of Capital Technology Information Services, Inc., a Capital Surini Group International, Inc. Company.

TrialMaster offers unrivaled freedom to conduct clinical trials, with unparalleled flexibility, ease-of-use and complete control over clinical data. TrialMaster employs forward-looking technology based on a Service Oriented Architecture (SOA) with an underlying Microsoft® .NET architecture, providing a simple "drag and drop" design tool that doesn't require any programming. With a clean user-friendly and intuitive GUI based on a logical build process that allows easy, rapid trial development and deployment, TrialMaster allows research organizations to capitalize on EDC their way. With LogiXML Ad-Hoc reporting fully integrated to the solution users enjoy completely interactive point-and-click access to all of their trial data. On-demand importing of CDISC, HL7, core labs and patient diary data is built in and the sophisticated export features in TrialMaster includes output to client systems in SAS, CDISC, CSV, TAB and XML formats. In a market overview titled "The Promise of Next-Gen eClinical Trial Software" by Forrester Research, OmniComm was given the highest rating among its competitors for industry middleware.

"The depth of experience that CTIS brings to our partnership in the government sector is unmatched in the clinical trial market space," said Cornelis Wit, President and CEO of OmniComm. "This partnership with OmniComm integrates CTIS' government experience with our proven track record in the commercial EDC market creating a first of its kind offering."

About CTIS

CTIS is a Rockville, Maryland company founded in 1988 as a clinical informatics company with an on-going commitment to provide tools and solutions in the clinical trials research and management space that contributes positively to patient safety and effective disease management. From 1997 to 2005, CTIS achieved an aggregate growth rate of over 22.8% generating revenues in excess of $280M and a growing client base. As a result of this success, CTIS has been included in Deloitte and Touche's Fast 50 list of rapidly growing IT companies in Maryland for seven years in a row.

CTIS' credentials are reflected in its receiving "excellent or outstanding" grades on its contract efforts over 90% of the time from its NIH clients. Furthermore, CTIS' NCI CTEP project was judged by OMB as the highest rated IT contract investment across all of the Department of Health and Human Service (DHHS) for the period 2004-2005 with an independently verified 250% ROI.

CTIS provides the methods and tools with which all clinical trials stakeholders (sponsors, regulators, auditors, sites, physicians and patients) are able to reduce the time it takes to complete clinical trials, improve their productivity, and increase their efficiency. CTIS' solutions create value for customers by combining expertise in IT solutions with deep domain knowledge in the clinical trials process. These solutions include regulatory compliant information repositories, stakeholder connectivity and improved quality of information to generate significant return on investment for their clients.

About OmniComm

OmniComm Systems, Inc. ( 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's intuitive pricing model allows companies that range from small to mid-size to large scale institutions to safely and efficiently capitalize on their clinical research investments.

OmniComm is ranked in the top 150 as one of the fastest revenue growth technology companies in North America during the last 5 years. In a market overview titled "The Promise of Next-Gen eClinical Trial Software" by Forrester Research, OmniComm was given the highest rating among its competitors for industry middleware. OmniComm Systems Inc. has corporate headquarters in Ft. Lauderdale, Florida with offices in California, Maryland, New Jersey, North Carolina, Texas and The Netherlands.

Safe Harbor Disclaimer

Statements about OmniComm's future expectations, including without limitation, future revenues and earnings, plans and objectives for the future operations, future agreements, future economic performance, operations and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. OmniComm intends that such forward-looking statements be subject to the Safe Harbors created thereby. Since these statements involve risks and uncertainties, including but not limited to economic competitive, governmental, contractual and technological factors affecting OmniComm's operations, markets and profitability, actual results could differ materially and adversely from the expected results.

Contact Information

    Lizanne Kelley
    OmniComm Systems, Inc.
    954-473-1254 Extension 283
    Email Contact