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:6/24/2016)... discussions on a range of subjects including policies, debt and ... Poloz. Speaking at a lecture to the Canadian ... to the country,s inflation target, which is set by both ... "In certain areas there needs to be ... why not sit down and address strategy together?" ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial spectrophotometers and fluorometers ... the 6000i models are higher end machines that use the more unconventional z-dimension of ... beam from the bottom of the cuvette holder. , FireflySci has developed several ...
(Date:6/23/2016)... ... June 23, 2016 , ... Mosio, ... second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering with experienced clinical ... eBook by providing practical tips, tools, and strategies for clinical researchers. , “The ...
(Date:6/23/2016)... , June 23, 2016   Boston ... of novel compounds designed to target cancer stemness ... has been granted Orphan Drug Designation from the ... treatment of gastric cancer, including gastroesophageal junction (GEJ) ... inhibitor designed to inhibit cancer stemness pathways by ...
Breaking Biology Technology:
(Date:4/28/2016)... , April 28, 2016 First quarter ... (139.9), up 966% compared with the first quarter of 2015 ... totaled SEK 589.1 M (loss: 18.8) and the operating margin was ... (loss: 0.32) Cash flow from operations was SEK 249.9 ... 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. The ...
(Date:4/26/2016)... 27, 2016 Research and ... Biometrics Market 2016-2020"  report to their offering.  , ... The analysts forecast the global multimodal biometrics ... during the period 2016-2020.  Multimodal biometrics ... such as the healthcare, BFSI, transportation, automotive, and ...
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
Breaking Biology News(10 mins):