Is outsourcing clinical trial services a smart strategy or a risky gamble? The answer depends on how you approach it. This topic was particularly highlighted for me during the Outsourcing in Clinical Trials East Coast conference, which took place at the Valley Forge Casino Resort…
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Business InsightsClinical Trial Writing and DesignPatient EngagementPatient Recruitment and Retention
Clinical Trial Diversity Action Plans: 6 Key Components for Compliance
Diversity in clinical trials is now mandated by law. While the importance of study diversity has long been emphasized, this marks the first time it has been codified into law under the Food and Drug Omnibus Reform Act of 2022 (FDORA).1 Through diversity action plans,…
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Business InsightsClinical Trial Writing and DesignPatient Recruitment and Retention
The Upcoming FDA Clinical Trial Diversity Mandate: What You Need to Know
In January 2024, I wrote about the FDA’s then-pending clinical research diversity requirements. Since that time, the regulatory landscape has shifted dramatically. This update outlines the most recent developments—including federal mandates under the Food and Drug Omnibus Reform Act (FDORA), the status of the FDA…
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Business Insights
What makes an effective clinical trial project manager?
by Hope Cullenby Hope CullenEffective clinical trial project managers do more than just keep tasks on schedule; they play a crucial role in ensuring project success and operational efficiency. Organizations that adopt project management practices achieve a 92% success rate in meeting their project goals and experience 28 times…
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Ancillary Trial Supplies and EquipmentLife-Science EventsSite Materials & Logistics
Keeping Clinical Trials on Track: Navigating Supply Chains, Tariffs, and Regulatory Shifts.
by Dan McDonaldby Dan McDonaldChanges taking place in the United States and internationally may affect the clinical trials landscape in the months and even years to come. Here are a few observations: FDA The U.S. Department of Health and Human Services is reducing its workforce and streamlining its functions.…