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:3/31/2015)... , March 31, 2015  On May ... will convene in Santa Monica, CA ... on Lung-Sparing Therapies for Malignant Pleural Mesothelioma (MPM), ... exposure to asbestos and commonly affects the lining ... co-hosted by UCLA and the Pacific Mesothelioma Center ...
(Date:3/31/2015)... March 31, 2015 PGI has announced an ... North America at its ... The anticipated plant expansion is centered on solving the ... differentiated products for personal care product manufacturers. ... with in-line slitting and packaging, will allow customers to ...
(Date:3/31/2015)... , March 31, 2015 /CNW/ - T-Bird Pharma Inc. (TSXV:TPI) ... developing premium quality medical marijuana products and a licensed ... Medical Purposes Regulations ( Canada ) ("MMPR"), ... from The Corporation of the District of ... the Company,s premises which now allows for commercial distribution ...
Breaking Medicine Technology:Cutting-Edge Research to Be Presented at 5th Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma in Santa Monica 2Cutting-Edge Research to Be Presented at 5th Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma in Santa Monica 3Cutting-Edge Research to Be Presented at 5th Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma in Santa Monica 4PGI Expands Manufacturing Capabilities At Mexico Plant 2T-Bird Pharma Inc. Announces Final Municipal Rezoning Approval 2T-Bird Pharma Inc. Announces Final Municipal Rezoning Approval 3
(Date:3/31/2015)... NJ (PRWEB) March 31, 2015 Dr. Russell ... for Advanced Reconstruction. He was recently quoted in an ... caused by lymphatic issues, causing fluid retention and tissue swelling. ... procedure to relieve and / or improve lymphedema symptoms. ... improve or alleviate the symptoms of lymphedema. The goal ...
(Date:3/31/2015)... Dr. Uzma Parvez is having a busy start to ... Grounds Presentations at St. Michael’s Medical Center for attending staff ... The event was attended by a large gathering of students, ... from the Grand Rounds. It was said that it ... while. , Ahead, Dr. Parvez has been invited to ...
(Date:3/31/2015)... TX (PRWEB) March 31, 2015 One of the ... be a visit to Mount Kilauea on the big island. ... few places where you can see molten lava slowly oozing at ... on earth. , One place you would never expect ... the flat, arid terrain of Mission, Texas -- until now. , ...
(Date:3/31/2015)... March 31, 2015 BESLER Consulting ... entitled, “The Value of an Independent Cost Report ... play a critical role in the determination of ... the appropriate understanding and review, this report can ... strategic planning. , This white paper discusses:, ...
(Date:3/31/2015)... WA (PRWEB) March 31, 2015 ... insurance exchange technology, has announced that Lance Hood, Senior ... HealthCare Consumerism Private Exchange Forum on April 1, 2015. ... Development of Benaissance, will address how employers can streamline ... process. , WHAT: “ Optimizing Employee and Employer ...
Breaking Medicine News(10 mins):Health News:The Physicians at Plastic Surgery Center Each Have Something to Celebrate This March 2Health News:The Physicians at Plastic Surgery Center Each Have Something to Celebrate This March 3Health News:The Physicians at Plastic Surgery Center Each Have Something to Celebrate This March 4Health News:NJ Top Docs Presents, Dr. Uzma Parvez of Total Pain Care 2Health News:Rare Volcano Constructed inside Gold’s Gym in Mission, Texas 2Health News:Rare Volcano Constructed inside Gold’s Gym in Mission, Texas 3Health News:Array Health’s Senior Director of Marketing to Co-Present with Benaissance at The Institute for HealthCare Consumerism Private Exchange Forum 2
... Doheny HealthDay Reporter , THURSDAY, June 24 ... to reduce the risk of invasive breast cancer by ... a woman is considering bisphosphonate use for bone, this ... Chlebowski, a clinical oncologist at the Los Angeles Biomedical ...
... , THURSDAY, June 24 (HealthDay News) -- Ninety percent of ... government report reveals. In fact, salt is so pervasive ... consume less. Too much salt can increase your blood pressure, ... "Nine in 10 American adults consume more salt than ...
... readily and safely distinguished the brains of Alzheimer,s disease ... the doors to making such imaging available beyond facilities ... reported by a Johns Hopkins team in the June ... better ways to distinguish Alzheimer,s from other types of ...
... at Erasmus MC University Medical Centre in The Netherlands ... for the development of de novo cancer in liver ... of Liver Transplantation , a journal published by ... Study of Liver Diseases (AASLD). The 1-year survival ...
... Previous studies have shown that antiviral treatment reduces the ... hepatitis B (CHB). But now, researchers from the Division ... reporting that the antiviral therapy also prevents recurrence of ... of care for patients with HCC is local ablation ...
... NEW YORK (June 24, 2010) A team of ... developed a method to predict post-stroke recovery of language ... to predict recovery has important implications for stroke survivors ... long-term treatment needs. Findings are reported online in the ...
Cached Medicine News:Health News:Bone-Building Pills Appear to Lower Invasive Breast Cancer Risk 2Health News:Bone-Building Pills Appear to Lower Invasive Breast Cancer Risk 3Health News:Most Americans Get Too Much Salt 2Health News:Most Americans Get Too Much Salt 3Health News:Novel radiotracer shines new light on the brains of Alzheimer's disease patients 2Health News:Higher cancer rates found in liver transplant patients receiving cyclosporine for immunosuppression 2Health News:Higher cancer rates found in liver transplant patients receiving cyclosporine for immunosuppression 3Health News:Silencing hepatitis B virus prevent recurrence of liver cancer 2Health News:New metric predicts language recovery following stroke 2
Inquire...
... the elegant and sophisticated woman, ... includes ophthalmic and sunwear styles. ... variety of shapes and colors, ... shapes and complexions. Many styles ...
... updated styling through the use of innovative ... collection is for the value driven consumer ... Eyewear Collection , The futuristic quality ... of the "strongest and lightest metal on ...
Inquire...
Medicine Products: