Nextrials Meets with CDER Healthcare IT Group

At the invitation of the FDA, Nextrials 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. 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.