Navigation Links
The First Risk-based & Centralized (Remote) Monitoring Platform is Here
Date:8/16/2013

CARY, N.C., Aug. 16, 2013 /PRNewswire-iReach/ -- The ROMaN Project, Inc. announces its endorsement of the Food and Drug Administration's (FDA) guidance to utilize risk-based monitoring in clinical trials. Risk-based monitoring focuses attention to the most critical data elements in a study and allocates monitoring resources to the investigator sites with problematic or unproven protocol compliance and/or data integrity.

(Photo: http://photos.prnewswire.com/prnh/20130816/MN64195)

The ROMaN Project's LORACIS™ is the first comprehensive remote monitoring platform available for the clinical trials industry, and is designed to fulfill the FDA's guidance on remote, central and risk-based monitoring. With this platform, sponsors and contract research organizations (CROs) can now verify study data and compliance remotely using a centralized database of redacted and certified source documents.

"Risk-based monitoring, including the appropriate use of centralized monitoring and reliance on technological advances can meet statutory and regulatory requirements," according to the FDA's recent statement, Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (FDA, August 2013.) "Incorporation of centralized monitoring practices, where appropriate, should improve a sponsor's ability to ensure the quality of clinical trial data."

Employing monitoring strategies away from the study sites requires a secure central repository containing the study patients' records and important study documents. Although not all centralized monitoring has to be remote (off-site), and not all remote monitoring must use a centralized repository of records; the two terms are usually interchangeable.

Centralized monitoring processes can provide many of the capabilities of on-site monitoring.  "We can ensure that the processes and expectations for site record keeping, data entry and reporting are well defined. Plus, our remote monitoring platform can support rapid access to clinical trial data and documentation from anywhere in the world," states Bruce Ross, The ROMaN Project's chairman and CEO.

At the study site, study personnel use LORACIS™ to process any paper or electronic study document; and in this one step, documents are instantly redacted, certified and uploaded to a secure central repository. Its web portal can be viewed across the globe with a standard Internet browser, allowing sponsors and CROs to quickly verify study data and ensure protocol compliance, thereby eliminating unnecessary travel to each study site. Because each hour of travel time saved by remote monitoring is an hour gained of productive monitoring time, the reduction in travel time and expenses result in significant cost savings.

The FDA believes that verification of study subjects' informed consent is a critical activity that should be monitored. "This is of most importance because LORACIS™ was designed from the first keystroke to allow the remote verification of consent forms," says Ross.

LORACIS™ is fully compliant with 21 CFR Part 11, HIPAA, and the EU privacy directives. 

For a LORACIS™ remote monitoring demonstration, email us at info@roman-project.com or call +1 (919) 228-2279. For investment opportunities, please email mailto: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 monitoring solutions provider, has revolutionized the way the clinical trial industry does its monitoring! LORACIS™ remote monitoring platform allows for study sponsors and CROs to save money, reduce travel time, and get rapid access to their sites' study documents.

www.roman-project.com

Media Contact: Dahlia Kelada, Kelada Creative Group LLC, 281-684-0755, dahlia@keladacreativegroup.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE The ROMaN Project, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) to Report First Quarter Financial Results on April 20
2. Thoratec Schedules First Quarter Conference Call, Webcast
3. Watson to Host Conference Call and Webcast to Discuss First Quarter 2012 Earnings
4. CVS Caremark Corporation to Hold First Quarter 2012 Conference Call
5. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
6. Alexza to Announce 2012 First Quarter Financial Results on Thursday, May 10, 2012
7. 3SBio Inc. Schedules Unaudited First Quarter 2012 Results
8. Insmed to Host 2012 First Quarter Earnings Conference Call
9. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
10. Henry Schein to Webcast First Quarter 2012 Conference Call Tuesday, May 8, at 10:00 a.m. EDT
11. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... 26, 2016 Story Highlights: ... models within the health care industry is causing providers ... , Deloitte offers a suite of solutions for ... impacting efficient cost optimization: labor resource analysis, revenue cycle ... facilitate better outcomes and better economics ...
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
(Date:6/24/2016)... 24, 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... develops, markets and sells medical devices and wearable sleep ... a strategic cooperation agreement with Hongyuan Supply Chain Management ... on June 20, 2016, to develop Dehaier,s new Internet ... agreement, Dehaier will leverage Hongyuan Supply Chain,s sales platform ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... ... is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience ... Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is ...
Breaking Medicine News(10 mins):