FEATURED ARTICLES
The formation of clinical trial site networks appears to be rising in popularity. Understand how these integrated networks can contribute to more effective, patient-centric trials — if done correctly.
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Site Feasibility Tips For Cell And Gene Therapy Clinical Trials
Site feasibility assessment can be challenging. Therefore, it’s essential to have a solid understanding of the regulatory obligations for investigators and sites when it comes to choosing each.
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Trends In FDA FY2023 Inspection-Based Warning Letters
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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A Tribe Called SOS
A first-hand account of a first-time industry conference. Dan Schell, chief editor of Clinical Leader, talks about his impressions of the Save Our Sites (SOS) conference that happened in Tucson, AZ on Feb. 2, 2024.