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news.OmniComm Systems signed a $2.5m contract for one Phase II and four Phase III global studies with a major east coast biotechnology company to supply OmniComm's electronic data capture (EDC) technology, TrialMaster 4.2.
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TrialMaster EDC was selected in part for its Custom Data Export Utility. This enables compliance with the US Food and Drug Administration’s (FDA), 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.
OmniComm Systems business development senior vice president Dr Kuno van der Post noted TrialMaster 4.2 was developed with advanced innovative technology that addresses the increasing regulatory demands and growing interoperability needs of our clients.
"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," Dr Post added.