Jun 25 2013
The ROMaN Project, Inc. announced its global launch of LORACIS™ today, the first all-inclusive remote monitoring platform utilizing a web portal for remotely viewing clinical study documents.
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 needs, 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 document, 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 revolutionary 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 clinical 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.
LORACIS™ 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 president and chief operations officer. "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 [email protected] 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 24 – 26 in booth #2051. Their top executives will be on hand to answer your questions.
For investment opportunities, please email [email protected].
To view a video overview of LORACIS™ remote monitoring, please visit www.youtube.com/LORACIS
The ROMaN Project, Inc., a remote monitoring solutions provider, has revolutionized the way the clinical trial industry does its monitoring. http://www.roman-project.com
Source: http://www.roman-project.com/