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4/5/2011
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GE Healthcare Intros Clinical Research Management Solution

Centricity Research will support clinical trial billing compliance and drive better administration of treatment plans, processes, and protocols, said GE.

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GE Healthcare has launched Centricity Research (CR), a clinical research management solution (CRMS) that aims to drive better management of clinical research treatment plans, processes, and protocols while supporting research billing compliance. The tool can also integrate with electronic health record (EHR) systems.

Announced March 28, GE said Centricity Research is the industry's first enterprise-class CRMS. The software has been introduced at a time when healthcare organizations are adopting EHRs, which digitize medical records and allows clinicians to electronically access patient information.

Michael Nolte, VP and general manager of healthcare IT at GE Healthcare, said in an interview that Centricity Research can push and pull data to and from EHR systems.

"For example, when screening a new patient for a clinical research study, the patient is identified in the institution's EHR and all relevant patient information can be pulled into CR," Nolte said. "When a patient makes it past the screening phase of the study and is finally enrolled, CR can push basic information about the study to the patient's record in the EHR and emergency department systems so that emergency or intensive care physicians know about the study drugs or devices affecting the patient, should that patient experience a serious adverse event."

Centricity Research also helps institutions conducting clinical or translational research manage the growing complexity of research processes and compliance requirements. For example, Nolte said clinical research billing compliance requires a very different set of processes and solutions to avoid increasing regulatory risk.

"Even the organizations that have long histories of investment in research typically have highly manual, error-prone processes to manage this," Nolte said. "The advent of investment in other clinical systems (EHRs, etc.) introduces additional complexity in patient care for patients who are participating in clinical research. Finally, organizations like the [Clinical and Translational Science Awards] consortium increasingly create the need for research organizations to have an enterprise level view of their research activities in order to maximize the benefit of the National Institutes of Health investment in clinical research in their institutions."

Built on the foundation of GE's Centricity Patient Protocol Management platform, Centricity Research supports both the institutions' and researchers' efforts in achieving compliance, enhancing safety, and facilitating agency audits.

According to Nolte, the new solution can help address the Clinical Trial Policy established by Centers for Medicare and Medicaid Services. Complying with these policies is often challenging for research sites and healthcare organizations, which rarely have the understanding, experience, or authority necessary to define and implement a solution for compliant research billing.

"Centricity Research allows research staff to define all medical interventions which are part of a given study and link these events through provider calendars and fee schedules to an institution's scheduling and billing systems." Nolte said. "This process automatically labels the charges a patient incurs during the study to either the study's sponsor or the patient's payer with little or none of the human intervention involved in the highly manual and error prone 'bill hold' approach taken by most academic medical centers to solve this problem."

GE Healthcare also said it has developed a strategic partnership with Mdlogix, which developed its CRMS in collaboration with the Johns Hopkins University School of Medicine and other leading clinical research institutions.

"The enterprise deployment of CRMS at Johns Hopkins includes all departments in the School of Medicine," Dr. Dan Ford, vice dean of clinical research at the university, said in a statement. "We have over 4,000 protocols currently in CRMS, with over 1,100 of those being active, and approximately 25% of those protocols [are] using CRMS solely at the discretion of the researchers themselves because of the value they gain from the system. CRMS has helped us more efficiently manage the 30% increase we have achieved in the number of research studies conducted at the Johns Hopkins School of Medicine since 2007."

Centricity Research helps ensure adherence to protocols and maximizes clinical research dollars. In addition to EHR systems, the software can integrate with a variety of existing institutional systems, including electronic institutional review board systems and revenue cycle management systems.

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