Enhanced Workforce Training Key to Tackling Chronic FDA Inspection Citations

It’s a classic good news/bad news scenario. The bad news? U.S. Food and Drug Administration (FDA) officials keep finding the same operational problems over and over again during clinical trial site inspections, as evidenced by public Warning Letter reports. The good news? “Sponsors and sites are more open to the idea that we need more […]

CROs Driving Adoption of Innovative Clinical Operations Technology

While the clinical trials industry doesn’t have a reputation as a haven for early adopters when it comes to technology, contract research organizations (CROs) are the driving force for the trend in the industry, based on responses from 461 high-level personnel at CROs and sponsors. “Findings show CROs are leading the adoption of modern clinical […]

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FDA Revises Clinical Trial Expectations for Approved Drugs

To help industry better understand the agency’s latest thinking on when it may require clinical trials or postmarket studies for already-approved prescription drugs, the U.S. Food and Drug Administration (FDA) has released a draft revision of guidance on “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.” The […]

‘Wishful Thinking’ Undermines Clinical Trial Recruitment

Dale Carnegie and Norman Vincent Peale notwithstanding, there are limits to the power of positive thinking when it comes to clinical trial recruitment. It’s a common problem in the industry that contributes to some sobering statistics cited by Katie Eddleton, associate director of the Office of Clinical Research at University of Florida. For example, 11% […]

Risk-Based Monitoring Gains Influence on Clinical Trial Conduct

Risk-based monitoring (RBM) and risk-based quality management (RBQM) are “central to ensuring the safety of patients in clinical trials, and [are] expected to continue to grow in importance as [trials] become more numerous and complex,” according to a new white paper from the Association of Clinical Research Organizations (ACRO). However, the paper sounds an alarm […]