Navigation Links
Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information
Date:1/14/2014

Rockville, MD (PRWEB) January 14, 2014

Global Record Systems, LLC, (GRS), a company dedicated to developing innovative information technology solutions for patients, physicians, the biopharmaceutical industry, regulators, payers, and other health care stakeholders, announced today the signing of a three-year Research Collaboration Agreement (RCA) with the US Food and Drug Administration (FDA). This initiative is designed to generate disruptive solutions to challenges related to patient safety, clinical outcomes, and medication adherence.

It is estimated that 2 million Americans are harmed each year by various drug safety issues that result in as many as 100,000 deaths annually. Further, most current Risk Evaluation and Mitigation Strategies (REMS) are predicated on the passive reporting of adverse events by physicians and biopharmaceutical companies. Given this current approach, it is estimated that only 10% of actual important adverse events are reported to the FDA. The GRS’ EHDI proposes to address these issues by interacting directly with patients and, with patient consent, leveraging the health care information stored in Electronic Medical Records (EMRs).

Global Record Systems is providing a cloud-based digital health platform to collect patient-centered data on a near real-time basis. The FDA will provide GRS with clinical research questions to inform the data collection and analysis. FDA will not provide access to any confidential data. GRS’ EHDI will collect responses using patient-centered digital technologies including voice recognition software, EMRs, Smart Phones and Tablets at the point of care in doctors’ offices, retail pharmacies, and patient homes. The purpose of these queries and subsequent data analyses is to accumulate primary information in the “voice-of-the-patient” to improve patient safety and critical clinical outcomes. It is projected that the EHDI will collect approximately 100 million patient records over the next 3-4 years thus creating the largest database of its kind in the world. Through this system, it is anticipated that coded data from EMRs, global clinical trials, patient safety, clinical outcomes, and medication adherence will be collected and archived. FDA will be able to query the database to identify relevant clinical research information regarding public health benefits of medications.

Sandra Garrett, PhD, CEO of Global Record Systems said, “We envision this collaboration with the FDA as a new paradigm in the assessment of drug safety, clinical outcomes and medication adherence. By integrating longitudinal patient care and clinical outcomes data into a usable output that incorporates the “voice-of-the-patient” (the ultimate end-user of the healthcare system) in the EHDI, we anticipate an improved ability to track evolving patterns of medication safety and use. It is anticipated that the EHDI would provide regulators with the ability to track safety, efficacy, and outcomes in patients across a wide array of disease states. The net result would be important data that would be supplemental to traditional pre- and post-approval outcomes information (especially cardiovascular), REMS, or Registry programs while offering critical analyses of comparative effectiveness. Ultimately, such data could lead to better utilization of financial resources and better medical information directed at improving population health management.”

Read the full story at http://www.prweb.com/releases/2014/01/prweb11486304.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. MedImmune Announces Winners of Its 6th Annual Global Abstract Competition
2. MarketsandMarkets: Global Prostate Cancer Therapeutics Market worth $6,457 Million by 2020
3. Global Cleantech Cluster Association Names New York City Startup Rentricity to Global Top 10 List
4. StemCyte Adds World Class Talent to its North America and Global Operations
5. Sequenom Named to NASDAQ Global Select Market
6. Synthetic Biology: Emerging Global Markets
7. MacroGenics Receives Milestone Payment as Part of Its Global DART™ Alliance with Boehringer Ingelheim
8. Amgen to Present at the 30th Annual J.P. Morgan Global Healthcare Conference
9. Hemodialysis Machine Industry 2012 Global & China Market Research Report - ReportsnReports
10. MarketsandMarkets: Global Seed Treatment Market worth $3430.3 Million by 2016
11. Accuray Surpasses 600 Installations Globally
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/26/2017)... ... July 25, 2017 , ... In this ... understanding of the considerations needed for designing ideal guide RNAs and DNA oligo ... to create targeted double-strand breaks in genomic DNA has greatly simplified strategies for ...
(Date:7/26/2017)... ... July 26, 2017 , ... ... for the improvement of crop productivity and economics for the food, feed and ... scope of the agreement includes the research and development of microbiome-based seed treatments ...
(Date:7/24/2017)... ... July 24, 2017 , ... Charm Sciences, Inc. is pleased to announce ... Conference on Interstate Milk Shipments (NCIMS) Laboratory Committee and Appendix N Committee as a ... 1, 2017. , The NCIMS voted at its annual meeting in April, 2015 to ...
(Date:7/20/2017)... ... July 20, 2017 , ... Resoundant, Inc. is pleased ... centers around the U.S. that offer MR Elastography for liver fibrosis staging. ... biopsy for staging liver fibrosis assessment. , “MRE:connect was created in response to ...
Breaking Biology Technology:
(Date:3/29/2017)... , March 29, 2017  higi, the health IT ... North America , today announced a ... the acquisition of EveryMove. The new investment and acquisition ... of tools to transform population health activities through the ... data. higi collects and secures data today ...
(Date:3/27/2017)... ROCKVILLE CENTRE, N.Y. , March 27, 2017 ... by Healthcare Information and Management Systems Society (HIMSS) ... Analytics Outpatient EMR Adoption Model sm . In ... top 12% of U.S. hospitals using an electronic ... recognized CHS for its high level of EMR ...
(Date:3/24/2017)... Research and Markets has announced the addition of the "Global ... to 2025" report to their offering. ... The Global Biometric Vehicle Access System Market ... the next decade to reach approximately $1,580 million by 2025. ... for all the given segments on global as well as regional ...
Breaking Biology News(10 mins):