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Veloxis Pharmaceuticals Chooses TrialMaster® EDC for Risk-Based Monitoring

March 11, 2015


Dennis Constantinou
OmniComm Systems, Inc.

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Fort Lauderdale, FL, March 11, 2015 - OmniComm Systems, Inc. (OmniComm) (OTCQB: OMCM), a global leading provider of clinical data management technology, today announced that after a rigorous evaluation process of various commercially available EDC technologies, Veloxis selected TrialMaster EDC to run its Phase IV clinical studies.

TrialMaster’s risk-based monitoring capability was a significant factor in the decision process. The ability to collect and utilize many types of key risk indicators and subsequently adapt source data verification (SDV) requirements in response to risk was important in Veloxis’ decision. Now Veloxis will no longer solely depend on on-site monitoring, and will have access to more information remotely, minimizing on-site SDV activities.

Due to the unique nature of these studies, Veloxis specifically sought technology that would be easy to learn and intuitive to use for their investigative sites. Designed with compliance in mind TrialMaster EDC conforms to both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) risk-based monitoring draft guidance. TrialMaster’s depth and breadth of capabilities will ensure data quality, accelerate study setup, and provide enhanced site experience.

“The continued adoption of TrialMaster in the late phase market is a direct result of our strong development focus in this area over the last few years,” said Kuno van der Post PhD, senior vice president of business development at OmniComm Systems. “Our guided data entry and strong site focus as well as our most recent innovations, such as patient direct data entry and data grids, offer our clients a clear advantage in late phase.”

Supporting Information

About Veloxis

Veloxis is a specialty pharmaceutical company focused on the development and commercialization of Envarsus® (LCP-Tacro) for the prevention of organ rejection in kidney transplant patients. Veloxis was founded in June 2002 as a spin-off from H. Lundbeck A/S and is listed on NASDAQ OMX Copenhagen A/S (OMX: VELO). Veloxis is an international company with headquarters in Hørsholm, Denmark, and a fully owned subsidiary in New Jersey, U.S.

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 4,000 clinical trials. For more information, visit www.omnicomm.com.

OmniComm, TrialMaster, TrialOne, and Promasys are registered trademarks of OmniComm Systems, Inc. Other names may be trademarks of their respective owners.


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Dennis Constantinou
OmniComm Systems, Inc.