Allscripts, Microsoft aim to develop clinical research platform
Allscripts and Microsoft are working to develop a new research model to enable clinical research to be conducted via point-of-care technology platforms.
Initially, Veradigm—a payer and life sciences business unit in Allscripts—will extend its cloud-based electronic health records platforms to focus on supporting use of automated matching of patients and providers who may qualify for research studies.
The vendors expect to run pilot programs to better understand the work ahead.
“By integrating research at the point of care, we have the potential to lower costs, increase efficiencies and remove bottlenecks that inhibit research, all while improving the welfare of patients,” says Tom Langan, CEO at Veradigm. “The barriers preventing this shift have now largely been removed and what is needed is commitment to developing the technologies, workflows, processes and compliance frameworks to support it. Veradigm and Microsoft are stepping up to this commitment.”
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Microsoft believes working with Veradigm will help biopharmaceutical and clinical research organizations to better conduct research that in the future will improve quality of life, adds Chris Sakalosky, vice president of health and life sciences.
Two major research-oriented policy changes at the Food and Drug Administration during 2018 were designed to reduce barriers that have caused research inefficiencies and slowed innovation.
In July 2018, FDA released a guidance document, “Use of Electronic Health Record Data in Clinical Investigations,” which encouraged modernizing research by using electronic health records and newer technologies.
In December 2018, FDA then released more guidance, “Framework for FDA’s Real-World Evidence Program,” that described use of real-word data captured through routine care delivery to support approval of new indications for approved drugs and post-approval study requirements.