Clinical Guest Contributors
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Post-Pandemic Planning: Using Direct-To-Patient Deliveries For Supply Chain Management
2/23/2024
UCB Vice President – Head of Global Clinical Science and Operations Tero Laulajainen gets us up to speed on direct-to-patient (DTP) trials and how UCB is leveraging it today.
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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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4 Things I Learned At SCOPE 2024
2/21/2024
The Summit for Clinical Ops Executives (SCOPE) ran from Feb. 11-4. Discover four things Executive Editor Abby Proch learned at the annual event.
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The FDA Speaks Up For Quality Management: Must They Beg?
2/20/2024
The FDA's quality by design (QbD) and risk-based monitoring (RBM) messaging began more than 10 years ago with their guidance on RBM. Eleven years, five total related key guidance documents (listed below), and one global pandemic later, why aren’t we moving forward at more than a snail’s pace?
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How To Improve Your Clinical Finance Function
2/16/2024
In the finale of this three-part series on clinical finance, IGM Biosciences Vice President, Financial Planning & Analysis Chris Chan discusses how to leverage the role of clinical finance for clinical trial success.
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FDA’s CBER Issues Final Guidance For CAR T Cell Products
2/15/2024
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.
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Why Is Clinical Finance Important?
2/15/2024
In part two, IGM Biosciences Vice President, Financial Planning & Analysis Chris Chan explains just how important the role of clinical finance can be in bringing harmony and success into clinical research.
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Why Is Clinical Finance So Challenging?
2/14/2024
IGM Biosciences Vice President, Financial Planning & Analysis Chris Chan explains why the role of clinical finance can be so challenging to define, uphold, and even defend in the world of clinical research.
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Making Rare Disease Progress With Novel Strategies, Data Standardization, And More
2/14/2024
The integration of innovative research methodologies, coupled with the standardization of data and use of advanced visualization techniques, represents a holistic strategy to address the complexities of rare diseases.
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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.