Vatche Bartekian, President, Vantage BioTrials Inc. in Canada

Project Managers Often Lynchpin to Clinical Trial Success

So, you think you want to be a clinical trial project manager? It’s not an easy task. However, it can be an incredibly rewarding role because you have the opportunity to elevate clinical trial quality, says Vatche Bartekian, president of Vantage BioTrials. “Challenges often arise during a clinical study, and it’s the project manager’s responsibility […]

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 […]

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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.” […]

‘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% […]