ICH E6 (R2) Puts More Pressure on Quality Risk Management Plans

“Any risk management plan is going to be important, but even more so now because we have the ICH E6 revision [from the International Council for Harmonization] that explicitly calls for quality management” in the conduct of clinical trials, notes Deborah Rosenbaum, a clinical research consultant and trainer with Sarrison Clinical Research, llc. The ICH […]

Hiring CRAs: Shifting the Research Industry’s Focus on Experience to Competency

There are certainly benefits to hiring a seasoned professional for a position with significant responsibility. However, a stringent focus on level of experience has hindered clinical research organizations in recent years. The focus on experience has led hiring organizations to turn away capable individuals, particularly for the role of clinical research associate (CRA). Read More […]

Ernest Prentice, PhD, Associate Vice Chancellor for Academic Affairs, University of Nebraska Medical Center

Solid Definitions of ‘Noncompliance’ Can Minimize Clinical Trial Risks

Breaches in research integrity can happen anywhere, anytime, and at any point in the clinical trial process, warns Ernest Prentice, PhD, associate vice chancellor for academic affairs at the University of Nebraska Medical Center. The public must see that clinical research is ethical and in full compliance with regulations, Prentice says. “Conducting clinical trials is […]

FDA's Drug Trial Snapshots Report

FDA Report Shows Growth in Clinical Trial Participation Among Women, African Americans

A new report from the U.S. Food and Drug Administration (FDA) suggests there has been some improvement in terms of advancing diversity in clinical trial research, though recent reports suggest more work remains to be done. In 2016, FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel drugs, either as new molecular entities […]