Resilience is Key to Thriving as Clinical Trial Professional

Realtors half-jokingly say property value often comes down to three things: location, location, and location. For clinical trial practitioners, you might substitute the words “resiliency, resiliency, and resiliency,” says Barbara van der Schalie, a clinical trial manager with Leidos Biomedical Research, Inc. “One of the cornerstones for [your professional] success in clinical research is resilience, […]

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 […]

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 […]