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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 mi
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