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 th
'/>"/>

SOURCE The ROMaN Project, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

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:1/14/2014)... 2014 InformEx, North America,s ... of high-value chemistry, will hold the 30 th ... Miami Beach Convention Center from January 21-24. ... More than 3,500 attendees from top pharmaceutical, fine chemical ... conference, which includes on-site education sessions, daily networking events ...
(Date:1/14/2014)... , Jan. 14, 2014 Animal Emergency Critical Care, a ... Leesburg, Virginia is the first in ... chamber. Dr. Susan M. Barnes , Medical ... Barnes and husband, Dr. Cole Taylor , are avid scuba ... need for oxygen when air is thin," states Dr Barnes. She ...
(Date:1/14/2014)... WASHINGTON, New York , January 14, ... http://www.equashield.com ), the leading provider of Closed System Transfer Devices (CSTD) ... has achieved 60% year-over-year sales growth for ... Equashield,s closed systems reduce the risk of ... other medical professionals who prepare and administer ...
Breaking Medicine Technology:Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2Hyperbaric Veterinary Medicine (hvm) Announces Animal Emergency Critical Care Installs A Small Animal Hyperbaric Chamber 2Equashield's Sales Grow by 60% in 2013 2
... IPSWICH, Mass., April 12, 2011 New England Biolabs ... of reagents for life science research, announces that it ... the Netherlands, and Imperial Life Sciences (ILS), based in ... BIOKE, a Cell Signaling Technology (CST) Europe ...
... leading EchoStim® Echogenic Insulated needle has been improved. ... Blocks (PNBs) using nerve stimulation and ultrasound guidance ... has more, brighter, easier to see reflectors, which ... the benefits of using both nerve block techniques ...
Cached Medicine Technology:New England Biolabs Expands its Distribution Network through Collaborations in India and the Netherlands 2
(Date:4/14/2014)... treat children with uncomplicated acute appendicitis is a reasonable ... fewer missed school days, according to a pilot study. ... Hospital and published online April 12 in the ... the first prospective study on nonoperative management of acute ... , Researchers enrolled 77 patients age 7 to 17 ...
(Date:4/14/2014)... 2014, Perth, Australia. Drug discovery company Proteomics International ... of a companion diagnostic (CDx) test with the ... The research team authenticated the panel of biomarkers ... samples. Seven biomarkers were validated at high stringency ... The mass spectrometry data was then cross-validated using ...
(Date:4/14/2014)... 2014) When it comes to the cost and ... Patients get the best care when they are treated ... extensive experience in their current job, according to a ... and Columbia Business School. The study was published in ... Applied Economics . , The review of more ...
(Date:4/13/2014)... STANFORD, Calif. A low-cost empowerment program for ... and sexual harassment of these girls, who live ... and are frequently attacked, a large new study ... Stanford University School of Medicine, Lucile Packard Children,s ... No Worldwide, validated the program,s effectiveness in combating ...
(Date:4/11/2014)... the processes that control brain cell production could pave ... brain-related disorders. , Scientists have gained new understanding of ... how and when nerve and brain cells are formed ... and keeps it healthy. Their findings could help explain ... which is a fundamental characteristic of many diseases including ...
Breaking Medicine News(10 mins):Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 2Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 3Health News:Longer nurse tenure on hospital units leads to higher quality care 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 3Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 4
... WASHINGTON, May 12 A new report from ... medications for a variety of diseases often are ... and Asian Americans. This comprehensive review of studies ... Origins and Strategies for Addressing Ethnic and ...
... the personal injury attorney firm in Manhattan, is standing up against insurance ... ... 2009 -- New York personal injury lawyers can have a ... business. When it comes to frivolous lawsuits, these monsters want the public ...
... President of CanReg Inc., is pleased to announce that ... Executive Advisory Strategist to assist client firms with their ... with small to medium sized public and private biotechnology ... been on directing and managing regulatory affairs, most recently ...
... other strains of influenza, CDC says , , TUESDAY, May 12 ... seeing some complications among pregnant women as the swine flu ... at higher risk of complications of influenza, whether it,s the ... seeing some severe complications in women with this year,s novel ...
... The Pennsylvania Department of Aging and the Office of ... Council that will advise on new policies and procedures to ... citizens and those with disabilities prefer to live independently and ... so we want to make sure that the services we ...
... (Nasdaq: VOLC ), a leader in the ... and treatment of coronary and peripheral artery disease, said ... Annual JMP Securities Research Conference on Monday, May 18.The ... at 3:00 p.m., Pacific Daylight Time (6:00 p.m., Eastern ...
Cached Medicine News:Health News:Report Reveals Disparities in Pharmaceutical Treatment for Minority Patients 2Health News:Report Reveals Disparities in Pharmaceutical Treatment for Minority Patients 3Health News:Report Reveals Disparities in Pharmaceutical Treatment for Minority Patients 4Health News:Manhattan Personal Injury Attorney Blames Insurance Industry For Negative Perception Of Civil Justice System 2Health News:Swine Flu May Pose Problems for Pregnant Women 2Health News:Swine Flu May Pose Problems for Pregnant Women 3Health News:Swine Flu May Pose Problems for Pregnant Women 4Health News:Swine Flu May Pose Problems for Pregnant Women 5Health News:Swine Flu May Pose Problems for Pregnant Women 6Health News:Swine Flu May Pose Problems for Pregnant Women 7Health News:Swine Flu May Pose Problems for Pregnant Women 8Health News:Swine Flu May Pose Problems for Pregnant Women 9Health News:Pennsylvania Council Formed to Advise on Improving Services to Older Adults, People with Disabilities 2Health News:Volcano Corporation Presentation at JMP Conference to be Webcast 2
Empore Sealing Tape Pads are ideal for covering a 96 well plate during storage or transfer to another work station. Not intended for use with auto-injectors....
Mylar Plate Sealers 100/Box...
TD silicone foam compression pad. Use with plates sealed with TDX or OptiTape....
For use with 96-well plates, catalog # 410150...
Medicine Products: