FORT LAUDERDALE, FL--(Marketwired - March 17, 2014) -
OmniComm Systems, Inc. (OTCQB: OMCM
) signed a $2.5 million contract for one Phase II and four Phase III global studies with a major east coast biotechnology company to supply OmniComm's market leading electronic data capture (EDC) technology, TrialMaster 4.2. TrialMaster EDC was selected in part for its award-winning Custom Data Export Utility. This enables compliance with FDA's, soon to be mandated, requirement for all clinical data submissions to conform to the Study Data Tabulation Model (SDTM). Conventional methodologies, used for clinical data submission, are very costly and typically take months to complete. TrialMaster's Custom Data Export Utility significantly decreases time to submission and can have SDTM data sets ready within 48 hours of database lock. TrialMaster's unique capability converts clinical study data to SDTM formats during trial conduct in real time, resulting in lower costs, decreased cycle times, and reduced rework.
- These studies are anticipated to enroll over 3,000 subjects in over 20 countries commencing the second quarter of 2014.
- TrialMaster's underlying integration and interoperability technology will be used in these studies to integrate Interactive Voice Response System (IVRS), central and local laboratory and ECG data for these studies.
- These studies will leverage TrialMaster's embedded eLearning functionality that aids in training and ensures rapid user adoption.
- These studies will include the latest version of TrialMaster which includes hundreds of innovative productivity and functionality features, including auto-redaction for faster and more economically efficient, centralized monitoring.
- TrialMaster 4.2 was released in December 2013 with over 300 enhancements and many new innovative features such as auto redaction.
"TrialMaster 4.2 was developed with advanced innovative technology that addresses the increasing regulatory demands and growing interoperability needs of our clients," said Kuno van der Post, Ph.D., SVP Business Development, OmniComm Systems. "We are pleased with the market's very positive response to this highly innovative release, its uptake and adoption. We look forward to partnering with our client in delivering exceptional value and performance in these highly complex studies."
About OmniComm Systems
OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm Systems 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.
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.
OmniComm and TrialMaster are registered trademarks of OmniComm Systems, Inc. Other names may be trademarks of their respective owners.