Clinical Guest Contributors
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Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's What
7/1/2025
What do air traffic control, nuclear power plants, and aircraft carriers have in common? Patient recruitment expert Tatty Scott argues clinical researchers should look at these industries to inspire more precise trial execution.
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Breaking Free From The Acronym Soup: Rethinking The Role Of Technology In Clinical Trials
6/30/2025
Ascendis Pharma's Ivanna Rosendal details how clinical systems hinder clinical trial execution and why we should rethink how technology can support our trials.
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Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric Trials
6/27/2025
Gilead’s Carrie Frenette discusses the company's art campaign centered on primary biliary cholangitis to bring awareness to the condition and create more patient-centric trials for patients.
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Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And Accuracy
6/26/2025
Medicine is not one-size-fits-all. Here, strategic advisor Bill Hanlon implores pharma to develop therapeutics and diagnostics anchored by racial and ethnic diversity.
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It's Time To Change How We Engage Research Sites
6/25/2025
Site operations expert Maria Ladd argues for a major change in how sponsors and CROs communicate and work with clinical research sites.
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The Effects Of Most Favored Nation Drug Pricing On Clinical Trial Management
6/24/2025
Market expert Mathini Ilancheran explains how sponsors can mitigate the effects of "Most Favored Nation" drug pricing while maintaining trial integrity and accelerating time to market.
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Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
6/23/2025
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs
6/20/2025
The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.
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How Is RIM Software Transforming Regulatory Compliance?
6/20/2025
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
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Why CRA Proficiency Needs A Boost From Better Assessment And Training
6/20/2025
CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.