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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


1/14/2014 10:06:53 AM

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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.”

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