Virginia Nido, Global Head, Product Development Industry Collaborations, Roche and Genentech

Mobile Clinical Trial Success Hinges on Patient Engagement

While the benefits of using mobile technologies in clinical trials are self-evident to many in the industry, patients may still need some encouragement, says Virginia Nido, Global Head, Product Development Industry Collaborations, with Genentech, a member of the Roche Group. For example, some patients may balk at learning they won’t be making as many physician […]

Khady Ndour, Quality Monitor, Columbia University Medical Center

Industry Slow to Reap Benefits of ‘Paperless’ Trials

Good old-fashioned human aversion to change has slowed adoption of electronic tools for clinical trials that could bring industry the long sought “paperless office,” according to a panel of industry experts. A recent survey shows clinical trial site staff say electronic data – particularly electronic health records and electronic data capture – are among the […]

Stephen A. Sonstein, PhD, Chair of the CAAHEP’s Committee on Accreditation of Academic Programs in Clinical Research

New Standards for Accreditation Advance Professionalization of Clinical Research

Clinical research is taking another step toward professionalization with the anticipated approval  of new “Standards and Guidelines for the Accreditation of Academic Programs in Clinical Research” by the Commission on Accreditation of Allied Health Education Programs (CAAHEP), says Stephen A. Sonstein, PhD, professor and director of clinical research administration at Eastern Michigan University. Sonstein is […]

Debi Willis, CEO and Founder, PatientLink

PatientLink Captures ONC Challenge with Patient-Focused Data Platform

PatientLink, a software company based in Oklahoma City, Okla., has won first place in Phase 2 of the Office of the National Coordinator for Health Information Technology (ONC) Consumer Health Data Aggregator challenge. ONC is part of the U.S. Department of Health and Human Services. The competition was designed to inspire the development of third-party, […]

Quality Assurance Coordinators: Ensuring Quality at the Site Level

NOTE: The quality assurance coordinator role outlined in this article is based on how such a position has been implemented in real-world settings. Does risk-based monitoring (RBM) always provide the highest quality in data, compliance, and subject safety? The short answer is no. In 2013, the U.S. Food and Drug Administration (FDA) published guidance to […]