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The ROMaN Project, Inc. Release: the First Comprehensive Remote Monitoring Solution for the Clinical Trial Industry


6/24/2013 10:54:58 AM

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CARY, North Carolina, June 2 4 , 2013 – The ROMaN Project, Inc. announced its global launch of LORACIS™ today , the first all - inclusive remote monitoring platform utilizing a web portal for remote ly viewing clinical study documen ts.

In August 2011 , the Food and Drug Administration (FDA) asked the industry to develop new technologies and monitoring strategies to curb the rapidly escalating costs of clinical trials. LORACIS™ remote monitoring platform was created to answer those ne eds , and was specifically designed for study sponsors, contract research organizations, clinical trial centers, universities, cooperative groups, and federally - funded research organizations.

LORACIS™ creates a redacted and certified copy of any study docu ment, including subject source documents, regulatory files, and paper case report forms; where the copies are then transmitted to an ultra - secure web portal. The uploaded documents can be viewed using any standard Internet browser accessed from anywhere in the world.

The combination of its ease of use, integral audit trails for each document, and rapid access to source documents opens the door for use of risk - based and adaptive monitoring strategies. Study sponsors can now view the same documents as their monitors, and project managers can confirm their monitors are reviewing the study documents.

LORACIS™ can not only improve the quality of clinical trials, but it can increase productivity and save on travel costs by 50 percent! This is truly a revolution ary solution – the new future for the clinical trial industry,” states Bruce Ross, The ROMaN Project’s chief executive officer.

Users of this first - of - its - kind platform can reduce their onsite monitoring visits by up to 90 percent while still allowing for complete, 100 percent source document verification. Considering that the c linical trial industry’s global spending exceeded $42 billion in 2012 , there is unlimited potential for remote monitoring systems such as the LORACIS™ remote monitoring platform .

L ORACIS™ is fully compliant with 21 CFR Part 11, HIPAA, and the EU privacy directives. “We deliberately avoided using any “cloud” data storage to maintain the highest possible security of our databases and web portal , ” said Trace Brookins, The ROMaN Project ’s p resident and c hief o perations o fficer. “All incoming data and internal systems use hardware servers located in an ultra - secure data center a few miles from our office.”

For a LORACIS™ remote monitoring demonstration, email us at info@roman - project.com and be sure to visit The Roman Project , Inc. at the Drug Information Association’s 2013 49th Annual Meeting at the Boston Convention and Exhibition Center June 2 4 – 26 in booth #2051. Their top executives will be on hand to answer your questions.

For investment opportunities, please email investors@roman - project.com .

To view a video overview of LORACIS™ remote monitoring, please visit www.youtube.com/LORACIS

The ROMaN Project, Inc. , a remote mon itoring solutions provider, has revolutionized the way the clinical trial industry does its monitoring. http://www.roman - project.com

Media Contact:

Dahlia Kelada

Kelada Creative Group

dahlia@keladacreativ egroup.com



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