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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

llion 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.


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