Nextrials Presents to FDA on the Viability of Integrating Electronic Health Records for Improved Clinical Data and Drug Safety Reporting

June 16, 2015
Company Press Release

Applied Clinical Trials

SAN RAMON, CA and WASHINGTON, DC--(Marketwired - Jun 15, 2015) - (DIA 2015) -- At the invitation of the Food and Drug Administration (FDA), Nextrials, Inc. recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting. Using its electronic health record (EHR) integration tool, E2E™, Nextrials staged a live demonstration for the Center for Drug Evaluation and Research (CDER) Healthcare IT Group and authors of the FDA's eSource Guidance.

This demonstration enabled attendees to examine how the integration of electronic data collection (EDC) in clinical trials with individual patient EHRs could not only provide benefits from a regulatory perspective, but also could boost patient care from the standpoint of healthcare providers.

"We have worked alongside the FDA in the past on the related standards and also collaborated with them on live demos of the integration," said Nextrials CEO James Rogers. "This recent forum allowed us to engage in a productive discussion of how patient data collected directly from his or her EHR record can improve data quality and streamline drug safety reporting."

Nextrials also met with authors of the FDA eSource Guidance. The eSource Guidance provides recommendations for the use of electronic source data in FDA-regulated clinical investigations. The application of this guidance was discussed from the perspective of sponsors, patients, e-clinical software vendors and treating physicians.

Attendees at the Drug Information Association's 51st Annual Meeting, opening today through June 18 at the Walter E. Washington Convention Center in Washington, DC can learn more about the context of the FDA meeting, Nextrials' Prism platform, its EHR integration tool E2E and its new real-time ad-hoc reporting tool by visiting booth 2717.

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