Site Management/Investigator Payments Featured Articles
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Site Feasibility Tips For Cell And Gene Therapy Clinical Trials
2/22/2024
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
2/13/2024
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
2/5/2024
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.
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Why Pharmas/Biotechs Should Champion Non-Pharmaceutical Interventions For MDR Pathogens
2/5/2024
Multi-drug resistant (MDR) pathogens are an escalating concern. While the primary focus of MDR pathogen treatment strategies has revolved around the creation of innovative therapeutics, diagnostic tools, and antibiotic stewardship, there has been a limited emphasis on implementing non-pharmaceutical interventions (NPIs). Regardless of what indication your drug's clinical trial is investigating, implementing NPIs will actually help your trial be more successful.
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Donating Surplus Clinical Trial Supplies Is Sustainability’s “Low-Hanging Fruit”
1/29/2024
ClinOps professionals know all too well the waste that occurs with leftover trial kits that are destroyed at the end of the trial. Explore donation as a way to give those kits a second life.
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Two Sponsors And A Site Expert Walk Into A DCT Discussion
12/15/2023
Do DCTs live up to the hype? Three experts discuss new technologies, FDA regulations, and whether DCTs are making life easier or harder for patients and sites.
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5 Habits For Ship-Shape Source Data
11/28/2023
ALCOA+ — or Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available — is the basis for these must-follow tips from Moderna Senior Manager of R&D Quality Kaitlin Bova.
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My Opinion: CRCs, CRAs, and CTMs Have It Tough
11/27/2023
With 20+ years as a CRC, CRA, clinical trial manager, and project manager, Tiffany Ashton, MAS, CCRA talks about how difficult it can be working in some of these roles in today’s clinical trials industry.
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Best Practices For Conducting Clinical Trials In Africa
11/21/2023
With its rich ethnic diversity, low trial density, and developing healthcare infrastructures, Africa is poised to become the next frontier of clinical research.
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One Way To Address The Clinical Research Talent Shortage? With Nurses
11/20/2023
Now is the time to expand the clinical research talent pool by focusing on nurses, says consultant Janice "Jan" Nissen. Here, she outlines why they're a valuable resource and how to recruit them.