Leading this effort, Veradigm, a payer and life sciences-focused business unit within Allscripts, has signed a memorandum of understanding with Microsoft to develop an innovative integrated research model, enabling clinical research to be performed through point-of-care technology platforms. The initial focus of this collaboration will be to extend Allscripts' cloud-based electronic health record (EHR) platforms with innovative technologies focused on enabling integrated research - for instance point-of-care, automated "match-making" between study protocols and the patients and providers who may qualify for those studies. The joint effort is also expected to include pilot programs to better understand, inform and develop the necessary processes, workflows and compliance framework that may be necessary to support research performed within this new, integrated operating model.
This effort is designed to improve the time to market of new therapies while decreasing the cost of research and development. A major reason for the current inefficiencies in clinical research is that the operating model under which research is conducted today has remained largely unchanged, despite the scientific and technological breakthroughs of the last 30 years.
Interventional clinical trials remain the gold standard, and while real world evidence (RWE) is increasingly used, to date it is largely applied in post market introduction safety scenarios. The value of electronic health records (EHR) can be more fully realized with technologies and workflows to support clinical research and with this new model, research becomes a natural output of the care process.
Stephanie Reisinger, VP & GM at Veradigm explains, "Just as rideshare organizations such as Lyft replaced the traditional specialized taxi driver and dispatch service with technology enabled drivers, we envision a network of technology enabled research clinicians providing an alternative to the roles associated within the traditional clinical trial operating model."
Recent market events have paved the way for this evolution. In July 2018, the U.S. Food and Drug Administration authored a new guidance document titled "Use of Electronic Health Record Data in Clinical Investigations", which encourages modernization of clinical research by leveraging new technologies and Electronic Health Records (EHRs). In addition, in December 2018, the FDA released the "Framework for FDA's Real-World Evidence Program", describing the use of data captured through routine care delivery (real world data) supporting approval of new indications for approved drugs, and post approval study requirements.
"New technologies and models have the potential to drastically improve the clinical research process," said Chris Sakalosky, vice president, U.S. Health and Life Sciences at Microsoft. "Working alongside industry leaders like Veradigm, we believe solutions powered by Microsoft Azure and AI will help biopharmaceutical and clinical research organizations better conduct research, and, in the future, improve quality of life."
Tom Langan, CEO of Veradigm said, "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. The barriers preventing this shift have now largely been removed - what is needed is a commitment to developing the technologies, workflows, processes and compliance frameworks to support it. Veradigm and Microsoft are stepping up to this commitment."
Langan continued, "In partnership with Microsoft, Veradigm is committed to a holistic approach to developing the platform that supports integrated clinical research. The teams are prepared to work with the industry and regulators to ensure that the promise of this new approach is fully realized, bringing the practice of clinical research into the 21st Century."
About AllscriptsAllscripts (NASDAQ:MDRX) is a leader in healthcare information technology solutions that advance clinical, financial and operational results. Our innovative solutions connect people, places and data across an Open, Connected Community of HealthTM. Connectivity empowers caregivers and consumers to make better decisions, delivering better care for healthier populations.